Is Rogaine foam the same strength as Rogaine solution?

Both men's products say 5%, and the two figures are not measuring the same thing. The solution is "Minoxidil 5% w/v", a weight-per-volume, so the labelled 1 mL application is 50 mg of minoxidil and the day's dose is 100 mg. The foam is "Minoxidil 5% w/w (without propellant)", a mass fraction, against a dose of "half a capful". No approved minoxidil label states what half a capful weighs or measures, so there is no milligram figure for the foam and no way to compare the two.

Why is women's Rogaine 2% when men's is 5%?

Only one of the two women's products is 2%. The women's topical solution is "Minoxidil 2% w/v" under NDA 019501, delivering 20 mg per 1 mL application against the men's solution's 50 mg — a 2.5-fold difference at an identical volume and frequency. The women's foam, however, is 5% w/w, the same strength as the men's foam and under the same application number, and it is applied once a day rather than twice. "Women's Rogaine" is two products at two strengths.

Can a woman use men's Rogaine?

The men's labels say no, in three places each: the Warnings read "For external use only. For use by men only", the Do not use list opens with "you are a woman", and the carton front prints "Not For Use By Women". Both men's products also add "May be harmful if used when pregnant or breast-feeding." The restriction runs one way — neither women's label tells a man not to use it — and the practical difference between the men's foam and the women's foam is frequency, since both are 5% w/w under NDA 021812.

Does Rogaine work on a receding hairline?

The men's labels say it is not for that, and they say it twice. The Use statement is "to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)", and the Do not use list adds "your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline." The women's solution makes no such restriction — its Use statement is simply "to regrow hair on the scalp" — so the vertex-only rule is a fact about two of the four cartons rather than about minoxidil.

How long does one bottle of Rogaine last?

A 60 mL bottle of either solution lasts 30 days at the labelled rate of 1 mL twice a day, and the carton agrees: "One Month Supply. One 60 mL (2 fl oz) Bottle." A 60 g foam can has no equivalent answer. The men's carton calls one can a month and the women's calls one can two months, but neither label states how many applications a can holds or what half a capful is, so the number of days is not derivable from anything published.

How long before Rogaine works, and when should I stop?

That depends which carton. The men's products say "Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results", and put "you do not see hair regrowth in 4 months" on the Stop use list. The women's foam says results may occur at 3 months with once daily use, that some women need 6 months, and puts "you do not see hair regrowth in 6 months" on its Stop use list. Two months of difference on the same molecule.

One of the four labels answers, and it answers narrowly: "hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men" That is 48 weeks, on the men's 5% solution alone. The men's foam claims only that "hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months"; the 2% solution reports 8-month response rates; the women's foam makes no efficacy claim at all. Every label does agree on what stopping costs: "continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again."

Is Rogaine prescription or over the counter?

All four Rogaine products are over the counter. They carry Drug Facts panels rather than prescribing information — no indications section, no prescriber, no boxed warning. That is a fact about the dosage form and not about minoxidil: the same molecule as a 2.5 mg or 10 mg tablet is prescription-only, opens with a boxed warning about pericardial effusion progressing to tamponade, and is reserved for hypertension not manageable on a diuretic plus two other antihypertensives. The Rogaine panels still carry the family resemblance in one line: "Ask a doctor before use if you have heart disease."

Why do so many minoxidil products on DailyMed look like FDA labels?

Because an SPL existing is not the same as a drug being approved. DailyMed returned 552 minoxidil listings on 2026-09-20; of the 100 whose approval blocks were read, 47 were ANDAs and 53 were filed under a category that is not an approval — 48 as "OTC Monograph Drug", 4 as "unapproved drug other" and 1 as "unapproved homeopathic". That sample is DailyMed’s newest-first page, so it over-represents recent filings and is not a projection onto all 552. Minoxidil is approved by NDA and appears in no OTC monograph, so none of those three categories can properly apply to it, and one 5% listing read for this page carries an antifungal’s directions verbatim. The four products on this page all carry marketing category NDA, under applications NDA019501, NDA020834, NDA021812.

Brand — four over-the-counter products, one name

Rogaine

Four separately approved OTC drug products are sold as Rogaine. Two are 5%, one is 2%, and the two 5% foams share an application number while giving opposite frequencies out of an identical 60 g can.

Molecule: minoxidil
Manufacturer: Kenvue Brands LLC
Products under this name: 4
Last reviewed: September 2026

Why "5% minoxidil" does not identify a product

Minoxidil for hair is sold over the counter in the United States, and Rogaine accounts for four separately approved products under three applications — NDA019501, NDA020834, NDA021812. Two are topical solutions dosed with a dropper and two are pressurised foams dosed by capful. The men's solution is 5% w/v; the women's solution is 2% w/v; both foams are 5% w/w without propellant. Those two five-per-cents are not the same measurement. Weight-per-volume is a concentration you can multiply by a volume to get a dose; weight-per-weight on a foam whose propellant has been excluded from the calculation is a mass fraction with no stated denominator.

The clearest demonstration is the two foams. They carry the same application number, NDA 021812, the same active-ingredient line and the same 60 g can. The men's directs "apply half a capful 2 times a day to the scalp in the hair loss area"; the women's directs "apply half a capful once daily directly to the scalp in the hair loss area". The men's carton then sells three cans as a "Three Month Supply" and the women's sells one can as a "TWO MONTH SUPPLY". Same drug, same strength, same container, same application — one month per can against two, because the frequency on the panel is different.

None of this is a property of minoxidil. The molecule has no frequency, no scalp region, no sex restriction and no decision point; each of those belongs to a carton. The molecule does not even have an over-the-counter status: the same compound in tablet form is a prescription-only last-line antihypertensive whose label opens with a boxed warning about pericardial effusion and tamponade, and which says in its own words that using minoxidil tablets to promote hair growth "is not an approved indication".

What is true of Rogaine and not of minoxidil

Each row is something a reader would reasonably assume belongs to the molecule, and does not. These are the facts that change when the brand name on the carton changes, while the drug inside it does not.

Attribute	Rogaine	Elsewhere, same molecule
How often you apply itA man handed his partner's Rogaine foam and told to "use it as directed" would be applying half the labelled frequency, and she using his would be applying twice hers. Frequency here is a property of the carton and of nothing else.	Men's foam: "apply half a capful 2 times a day to the scalp in the hair loss area" Women's foam: "apply half a capful once daily directly to the scalp in the hair loss area" Both solutions: twice a day.	The two foams carry the same application number (NDA 021812), the same active-ingredient line (Minoxidil 5% w/w without propellant) and the same 60 g can. Nothing about the molecule or the formulation changes between them — only the panel.
What a 60 g can is worthThe same container is labelled one month and two months by the same manufacturer, which is arithmetically consistent with the frequency difference and completely inconsistent with treating "a can of Rogaine foam" as a unit of anything.	The men's foam carton sells three cans as "Three Month Supply • Three 60 g (2.11 oz) Cans" — one month per can.	The women's foam carton sells one identical can as "TWO MONTH SUPPLY ONE 60 g (2.11 OZ) CAN" — two months from the same 60 g.
The unit the strength is printed inA 5% solution and a 5% foam do not deliver a comparable amount of drug, and nothing on either label lets you work out by how much. The number on the front of the can and the number on the front of the bottle are measuring different things.	Solutions: 5% w/v and 2% w/v — a weight-per-volume, which at the labelled 1 mL gives 50 mg and 20 mg per application.	Foams: 5% w/w, printed as "Minoxidil 5% w/w (without propellant)" — a mass fraction with the propellant excluded, against a dose of "half a capful". No approved minoxidil label states what half a capful weighs or measures, so neither a millilitre nor a milligram figure exists for either Rogaine foam. The strength is printed weight-per-weight without the propellant, which is a mass fraction rather than a concentration, and a capful is defined by the can’s own cap and by nothing else.
The strength itselfTwo bottles that look the same, hold the same 60 mL, are dropped on the scalp in the same 1 mL doses, and are not the same medicine. The men's label records the comparison: the 5% "provided more hair regrowth than 2% minoxidil topical solution".	Men's solution: 5% w/v, 100 mg of minoxidil a day at the labelled rate.	Women's solution: 2% w/v, 40 mg a day at the same 1 mL twice daily. A 2.5-fold difference in delivered drug at an identical volume and frequency.
Which part of the scalp it is forThe single most common complaint about topical minoxidil is that it did nothing for a receding hairline. The men's labels say so in advance and the women's solution label does not make the restriction at all — so "minoxidil is vertex only" is a statement about two of the four cartons.	Men's products confine the Use statement to the crown: "to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)", and the Do not use list adds that the product "is not intended for frontal baldness or receding hairline".	The women's solution Use statement is "to regrow hair on the scalp" — no region named, no vertex parenthetical, no frontal exclusion. The women's foam says "top of the scalp" without "vertex only".
Who may use itThe prohibition runs one way. A product with the same molecule at the same 5% strength is forbidden to women on one carton and sold to them on another, and the difference is the frequency and the trial population behind each panel, not the chemistry.	Men's products: "For external use only. For use by men only." Do not use if "you are a woman". The carton prints "Not For Use By Women" on the front of both.	Neither women's product carries a reciprocal restriction. The women's solution Warnings read "For external use only" and nothing further, and neither women's label tells a man not to use it.
When to give upSomeone who abandons a once-daily women's foam at four months because "the label says four months" is stopping two months before their own label's decision point. The number belongs to the panel, not the drug.	Men's products: "it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results." and the Stop use list carries "you do not see hair regrowth in 4 months".	Women's foam: "it takes time to regrow hair. Results may occur at 3 months with once daily use. For some women, you may need to use this product once a day for at least 6 months before you see results." and its Stop use list carries "you do not see hair regrowth in 6 months" — a decision point two months later than the men's, on the same molecule at the same strength.
How long the regrowth has been shown to last48 weeks is the furthest point any Rogaine label makes a durability claim about, and it is on one of the four products. Quoting it as "minoxidil has not been shown to work past 48 weeks" attaches a single label's sentence to three other products that never said it.	The men's 5% solution alone states it: "hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men"	The men's foam says only "hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months". The 2% solution reports 8-month response rates instead — 19% of women reported moderate regrowth against 7% on placebo. The women's foam makes no efficacy claim at all.
Whether a warning box exists at allWhether this molecule needs a cardiology plan depends entirely on the dosage form. The oral label also settles the question people bring to the topical one: "Use of minoxidil tablets, in any formulation, to promote hair growth is not an approved indication."	None of the four. These are OTC drug products with Drug Facts panels — no boxed warning, no prescriber, no Medication Guide. The strongest cardiovascular language is a Stop use bullet: "chest pain, rapid heartbeat, faintness, or dizziness occurs".	Minoxidil tablets (ANDA 071826) open with a boxed warning: the drug "can cause pericardial effusion, occasionally progressing to tamponade, and angina pectoris may be exacerbated", must "usually" be given with both a beta-blocker and a loop diuretic, and is reserved for hypertension unmanageable on a diuretic plus two other antihypertensives.

MEN'S ROGAINE EXTRA STRENGTH UNSCENTED

Dosage form: Solution, for topical use
Route: Topical, to the scalp, twice daily
Marketing category: NDA — NDA020834
Label read: SPL version 5, effective September 6, 2024

What this product is approved to treat

—Use: "to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)"
—Purpose: "Hair regrowth treatment for men". This is an over-the-counter drug product, not a prescription medicine — there is no indication section, no prescriber and no boxed warning, only a Drug Facts panel.
—Do not use if "your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline."

The labelled ladder

When	Dose	What the label attaches to this step
Day 1 onward	1 mL, 2× daily	"apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area" At 5% w/v that is 50 mg of minoxidil per application and 100 mg a day — derived from the percent and the stated millilitre, not printed on the carton. The label adds: "using more or more often will not improve results."
Month 2	1 mL, 2× daily	The earliest point this label claims anything. "it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results."
Month 4	1 mL, 2× daily	The decision point, from the Stop use and ask a doctor list: "you do not see hair regrowth in 4 months". Nothing on this label describes continuing past a failure at this mark.
Week 48	1 mL, 2× daily	From Other information: "hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men" That is the furthest point any Rogaine label makes a durability claim about, and it is on this product alone.
On stopping	None — treatment discontinued	"continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again" No Rogaine label describes a taper, and none states how quickly the loss resumes.

Ceiling. There is no maximum, because there is no titration and the label forecloses the question: "using more or more often will not improve results". One strength, one frequency, and the only quantity named is 1 mL per application. Anything above that is off-label use of an over-the-counter product.

How it is supplied

Presentation	Total strength	Concentration	Delivers
60 mL bottle — Solution, for topical use. Carton: "One Month Supply. One 60 mL (2 fl oz) Bottle"	60 mL at 5% w/v	50 mg/mL — 50 mg in the labelled 1 mL application	30 days at the labelled rate — the arithmetic the carton's own "1 month" claim agrees with (30 days).

Administration, as the label words it

—Active ingredient: Minoxidil 5% w/v.
—Directions: "apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area"
—Directions: "using more or more often will not improve results"
—Directions: "continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again"
—Warnings: "Ask a doctor before use if you have heart disease." Minoxidil is a potent vasodilator whose oral form is a last-line antihypertensive, which is why an over-the-counter hair product carries a Stop use list that opens with "chest pain, rapid heartbeat, faintness, or dizziness occurs".
—Do not use if "you are under 18 years of age. Do not use on babies and children." Do not use if "your hair loss is sudden and/or patchy", if "you have no family history of hair loss", if "you do not know the reason for your hair loss", if "your scalp is red, inflamed, infected, irritated, or painful", or if "you use other medicines on the scalp".
—"do not apply on other parts of the body" and "avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water."
—"May be harmful if used when pregnant or breast-feeding."
—Warnings: "For external use only. For use by men only." The carton repeats it: "Not For Use By Women". Do not use if "you are a woman".
—Other information: "hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men"
—Other information also records the comparison behind the "Extra Strength" name: "In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution."

Storage

Bottle: Store at controlled room temperature 20° to 25 °C (68° to 77 °F).; Until the expiration date on the carton
Solution: Warnings: "Flammable: Keep away from fire or flame." The vehicle is alcohol, propylene glycol and purified water.; Keep away from fire or flame while wet

Children and adolescents

Do not use if "you are under 18 years of age. Do not use on babies and children." The Drug Facts state this as a Do not use, not as an absence of data — which is stronger than the "have not been established" wording on the prescription testosterone and finasteride labels.

This statement belongs to MEN'S ROGAINE EXTRA STRENGTH UNSCENTED. It is not a statement about minoxidil, and another brand of the same molecule may say the opposite.

MEN'S ROGAINE MINOXIDIL — UNSCENTED FORMULA

Dosage form: Aerosol, foam, for topical use
Route: Topical, to the scalp, twice daily
Marketing category: NDA — NDA021812
Label read: SPL version 7, effective November 11, 2024

What this product is approved to treat

—Use: "to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)"
—Purpose: "Hair regrowth treatment for men". Over-the-counter, Drug Facts only.
—Do not use if "your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam is not intended for frontal baldness or receding hairline."

The labelled ladder

When	Dose	What the label attaches to this step
Day 1 onward	apply half a capful 2 times a day to the scalp in the hair loss area — no stated volume or weight	"apply half a capful 2 times a day to the scalp in the hair loss area" No approved minoxidil label states what half a capful weighs or measures, so neither a millilitre nor a milligram figure exists for either Rogaine foam. The strength is printed weight-per-weight without the propellant, which is a mass fraction rather than a concentration, and a capful is defined by the can’s own cap and by nothing else. There is no titration and no second strength under this carton — the dose is the same on day one and in year three.
Month 2	apply half a capful 2 times a day to the scalp in the hair loss area — no stated volume or weight	The earliest point this label claims anything. "it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results."
Month 4	apply half a capful 2 times a day to the scalp in the hair loss area — no stated volume or weight	The decision point, from the Stop use and ask a doctor list: "you do not see hair regrowth in 4 months". Nothing on this label describes continuing past a failure at this mark.
Trial horizon	apply half a capful 2 times a day to the scalp in the hair loss area — no stated volume or weight	From Other information: "hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months"
On stopping	None — treatment discontinued	"continued use is necessary to increase and keep your hair regrowth or hair loss will begin again" No Rogaine label describes a taper, and none states how quickly the loss resumes.

Ceiling. There is no maximum, because there is no titration and the label forecloses the question: "using more or more often will not improve results". One strength, one frequency, and the only quantity named is half a capful, which no label converts into a volume or a weight. Anything above that is off-label use of an over-the-counter product.

How it is supplied

Presentation	Total strength	Concentration	Delivers
60 g can — Aerosol, foam, for topical use. Carton: "Three Month Supply • Three 60 g (2.11 oz) Cans"	60 g at 5% w/w	Not printed in section 3 of the label	Not derivable. The carton claims 1 month from this can, but the label never states how many applications a can holds.

Administration, as the label words it

—Active ingredient: Minoxidil 5% w/w (without propellant).
—Directions: "apply half a capful 2 times a day to the scalp in the hair loss area"
—Directions: "massage into scalp with fingers, then wash hands well"
—Directions: "see enclosed booklet for complete directions on how to use"
—Directions: "using more or more often will not improve results"
—Directions: "continued use is necessary to increase and keep your hair regrowth or hair loss will begin again"
—Warnings: "Ask a doctor before use if you have heart disease." Minoxidil is a potent vasodilator whose oral form is a last-line antihypertensive, which is why an over-the-counter hair product carries a Stop use list that opens with "chest pain, rapid heartbeat, faintness, or dizziness occurs".
—Do not use if "you are under 18 years of age. Do not use on babies and children." Do not use if "your hair loss is sudden and/or patchy", if "you have no family history of hair loss", if "you do not know the reason for your hair loss", if "your scalp is red, inflamed, infected, irritated, or painful", or if "you use other medicines on the scalp".
—"do not apply on other parts of the body" and "avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water."
—"May be harmful if used when pregnant or breast-feeding."
—Warnings: "For external use only. For use by men only." The carton repeats it: "Not For Use By Women".
—Other information: "hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months" That is the whole of this label's efficacy statement — four months in one study, with no durability claim of any kind and no comparison against the 2% product.
—No approved minoxidil label states what half a capful weighs or measures, so neither a millilitre nor a milligram figure exists for either Rogaine foam. The strength is printed weight-per-weight without the propellant, which is a mass fraction rather than a concentration, and a capful is defined by the can’s own cap and by nothing else.

Storage

Can: Store at controlled room temperature 20° to 25 °C (68° to 77 °F).; Until the expiration date on the carton
Pressurised container: "contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 °F (49 °C)." The Warnings add "Extremely Flammable. Avoid fire, flame, or smoking during and immediately following application."; No exposure above 49 °C at any time

Children and adolescents

This statement belongs to MEN'S ROGAINE MINOXIDIL — UNSCENTED FORMULA. It is not a statement about minoxidil, and another brand of the same molecule may say the opposite.

WOMEN'S ROGAINE UNSCENTED

Dosage form: Solution, for topical use
Route: Topical, to the scalp, twice daily
Marketing category: NDA — NDA019501
Label read: SPL version 4, effective September 6, 2024

What this product is approved to treat

—Use: "to regrow hair on the scalp" — the whole of it. Unlike the men's products this Use statement names no region of the scalp and carries no vertex restriction.
—Purpose: "Hair regrowth treatment". Over-the-counter, Drug Facts only.
—Do not use if "your hair loss is associated with childbirth" — a Do not use that appears on neither men's carton.

The labelled ladder

When	Dose	What the label attaches to this step
Day 1 onward	1 mL, 2× daily	"apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area" At 2% w/v that is 20 mg of minoxidil per application and 40 mg a day — derived from the percent and the stated millilitre, not printed on the carton. The label adds: "using more or more often will not improve results."
Month 2	1 mL, 2× daily	The earliest point this label claims anything. "it takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results."
Month 4	1 mL, 2× daily	The decision point, from the Stop use and ask a doctor list: "you do not see hair regrowth in 4 months". Nothing on this label describes continuing past a failure at this mark.
Trial horizon	1 mL, 2× daily	From Other information: "In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth)."
On stopping	None — treatment discontinued	"continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again" No Rogaine label describes a taper, and none states how quickly the loss resumes.

How it is supplied

Presentation	Total strength	Concentration	Delivers
60 mL bottle — Solution, for topical use. Carton: "One Month Supply One 60 mL (2 fl oz) Bottle"	60 mL at 2% w/v	20 mg/mL — 20 mg in the labelled 1 mL application	30 days at the labelled rate — the arithmetic the carton's own "1 month" claim agrees with (30 days).

Administration, as the label words it

—Active ingredient: Minoxidil 2% w/v.
—Directions: "apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area"
—Directions: "using more or more often will not improve results"
—Directions: "continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again"
—Warnings: "Ask a doctor before use if you have heart disease." Minoxidil is a potent vasodilator whose oral form is a last-line antihypertensive, which is why an over-the-counter hair product carries a Stop use list that opens with "chest pain, rapid heartbeat, faintness, or dizziness occurs".
—Do not use if "you are under 18 years of age. Do not use on babies and children." Do not use if "your hair loss is sudden and/or patchy", if "you have no family history of hair loss", if "you do not know the reason for your hair loss", if "your scalp is red, inflamed, infected, irritated, or painful", or if "you use other medicines on the scalp".
—"do not apply on other parts of the body" and "avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water."
—"May be harmful if used when pregnant or breast-feeding."
—There is no sex restriction on this label. The Warnings read "For external use only" and stop there; there is no "For use by men only" and no "Not For Use By Women".
—Other information: "In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth)."

Storage

Bottle: Store at controlled room temperature 20° to 25 °C (68° to 77 °F).; Until the expiration date on the carton
Solution: Warnings: "Flammable: Keep away from fire or flame." The vehicle is alcohol, propylene glycol and purified water.; Keep away from fire or flame while wet

Children and adolescents

This statement belongs to WOMEN'S ROGAINE UNSCENTED. It is not a statement about minoxidil, and another brand of the same molecule may say the opposite.

WOMEN'S ROGAINE UNSCENTED (foam)

Dosage form: Aerosol, foam, for topical use
Route: Topical, to the scalp, once daily
Marketing category: NDA — NDA021812
Label read: SPL version 6, effective November 13, 2024

What this product is approved to treat

—Use: "to regrow hair on the top of the scalp (see pictures on side of this carton)" — the top of the scalp, but without the parenthetical "vertex only" the men's cartons carry.
—Purpose: "Hair regrowth treatment for women". Over-the-counter, Drug Facts only.
—Do not use if "your hair loss is associated with childbirth".

The labelled ladder

When	Dose	What the label attaches to this step
Day 1 onward	apply half a capful once daily directly to the scalp in the hair loss area — no stated volume or weight	"apply half a capful once daily directly to the scalp in the hair loss area" No approved minoxidil label states what half a capful weighs or measures, so neither a millilitre nor a milligram figure exists for either Rogaine foam. The strength is printed weight-per-weight without the propellant, which is a mass fraction rather than a concentration, and a capful is defined by the can’s own cap and by nothing else. There is no titration and no second strength under this carton — the dose is the same on day one and in year three.
Month 2	apply half a capful once daily directly to the scalp in the hair loss area — no stated volume or weight	The earliest point this label claims anything. "it takes time to regrow hair. Results may occur at 3 months with once daily use. For some women, you may need to use this product once a day for at least 6 months before you see results."
Month 6	apply half a capful once daily directly to the scalp in the hair loss area — no stated volume or weight	The decision point, from the Stop use and ask a doctor list: "you do not see hair regrowth in 6 months". Nothing on this label describes continuing past a failure at this mark.
Beyond the decision point	apply half a capful once daily directly to the scalp in the hair loss area — no stated volume or weight	This label makes no efficacy or durability claim at any timepoint. Its Other information section carries storage, the carton pictures and the pressurised-container warnings, and nothing about how long regrowth lasts.
On stopping	None — treatment discontinued	"continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again" No Rogaine label describes a taper, and none states how quickly the loss resumes.

Ceiling. There is no maximum, because there is no titration and the label forecloses the question: "using more or more often will not improve results". One strength, one frequency, and the only quantity named is half a capful, which no label converts into a volume or a weight. Anything above that is off-label use of an over-the-counter product.

How it is supplied

Presentation	Total strength	Concentration	Delivers
60 g can — Aerosol, foam, for topical use. Carton: "TWO MONTH SUPPLY ONE 60 g (2.11 OZ) CAN"	60 g at 5% w/w	Not printed in section 3 of the label	Not derivable. The carton claims 2 months from this can, but the label never states how many applications a can holds.

Administration, as the label words it

—Active ingredient: Minoxidil 5% w/w (without propellant).
—Directions: "see enclosed booklet for complete directions on how to use"
—Directions: "apply half a capful once daily directly to the scalp in the hair loss area"
—Directions: "massage into scalp with fingers, then wash hands well"
—Directions: "using more or more often will not improve results"
—Directions: "continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again"
—Warnings: "Ask a doctor before use if you have heart disease." Minoxidil is a potent vasodilator whose oral form is a last-line antihypertensive, which is why an over-the-counter hair product carries a Stop use list that opens with "chest pain, rapid heartbeat, faintness, or dizziness occurs".
—Do not use if "you are under 18 years of age. Do not use on babies and children." Do not use if "your hair loss is sudden and/or patchy", if "you have no family history of hair loss", if "you do not know the reason for your hair loss", if "your scalp is red, inflamed, infected, irritated, or painful", or if "you use other medicines on the scalp".
—"do not apply on other parts of the body" and "avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water."
—"May be harmful if used when pregnant or breast-feeding."
—There is no sex restriction on this label beyond its Purpose line.
—Other information makes no efficacy or durability claim at all — no trial, no timepoint, no percentage. The 8-month response figures belong to the 2% solution and the 48-week durability sentence belongs to the men's 5% solution; neither transfers here.
—No approved minoxidil label states what half a capful weighs or measures, so neither a millilitre nor a milligram figure exists for either Rogaine foam. The strength is printed weight-per-weight without the propellant, which is a mass fraction rather than a concentration, and a capful is defined by the can’s own cap and by nothing else.

Storage

Can: Store at controlled room temperature 20° to 25 °C (68° to 77 °F).; Until the expiration date on the carton
Pressurised container: "contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 °F (49 °C)." The Warnings add "Extremely Flammable. Avoid fire, flame, or smoking during and immediately following application."; No exposure above 49 °C at any time

Children and adolescents

This statement belongs to WOMEN'S ROGAINE UNSCENTED (foam). It is not a statement about minoxidil, and another brand of the same molecule may say the opposite.

The same molecule under other brand names

Everything below is minoxidil. None of it is Rogaine, and a dose from one column carried into another is not a smaller or larger version of the same instruction — it is a different product’s schedule.

Brand	Form	Approved for	Ladder	Maximum
Minoxidil tablets (generic; no brand currently marketed)	Oral tablet, 2.5 mg and 10 mg — prescription only, ANDA 071826	Hypertension "that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs". Boxed warning for pericardial effusion and tamponade; must usually be given with a beta-blocker and a loop diuretic	5 mg once daily → 10 → 20 → 40 mg (patients over 12)	The maximum recommended dosage is 100 mg per day
Kirkland Signature Minoxidil	5% topical aerosol foam — ANDA 091344, Costco Wholesale Company	Hair regrowth treatment for men, over the counter, on the same Drug Facts template as the branded foam	Half a capful twice a day — no volume or weight stated	No maximum; "using more or more often will not improve results"
Nizoral Hair Regrowth Treatment for Men	5% topical aerosol foam — ANDA 218616, Kramer Laboratories	Hair regrowth treatment for men. The Nizoral name belongs to a ketoconazole shampoo; this product is minoxidil and contains no ketoconazole	Half a capful twice a day — no volume or weight stated	No maximum; "using more or more often will not improve results"

Switching between products

The label forecloses the commonest self-adjustment

using more or more often will not improve results

All four Rogaine products

The only comparison between two Rogaine strengths that a label makes

In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

Men's Rogaine Extra Strength — the 5% solution

The oral label answers the question the topical labels are silent on

Use of minoxidil tablets, in any formulation, to promote hair growth is not an approved indication. While clinical trials with ROGAINE® Topical Solution 2% demonstrated that formulation and dosage were safe and effective, the effects of extemporaneous formulations and dosages have not been shown to be safe or effective.

Minoxidil tablets — the prescription oral product

What this page does not tell you

Price — shelf, subscription or per-month: No price appears anywhere on this page, and no price is emitted in its structured data. Rogaine is an over-the-counter product sold at whatever each retailer sets, in one-, three- and six-container cartons, alongside store-brand ANDAs of the same strength at a different figure in the same aisle. There is no list price to cite and re-verify the way every label quote here is cited, and a number that is stale the week after it is written is worse than no number. Our minoxidil bottle-duration tool works out how long a container lasts instead, which is the half of the cost question that is actually sourceable.
How much minoxidil is in half a capful of either foam: No approved minoxidil label states what half a capful weighs or measures, so neither a millilitre nor a milligram figure exists for either Rogaine foam. The strength is printed weight-per-weight without the propellant, which is a mass fraction rather than a concentration, and a capful is defined by the can’s own cap and by nothing else. This page will not divide a 60 g can by a thirty-day month and two applications to produce one gram per dose, because that would be our arithmetic printed as the manufacturer's, and the answer would then be quoted back as a labelled figure. The two solutions do get a milligram figure — 50 mg and 20 mg per application — because a percent weight-per-volume multiplied by a stated millilitre is a calculation the label supplies both halves of.
How many days a foam can lasts: Not derivable, and the page prints the refusal in the "How it is supplied" table rather than leaving the cell blank. The carton claims one month for the men's can and two for the women's, and both claims are reported above; neither label states how many applications a can holds or what one application is, so there is nothing to divide. The solutions get 30 days because 60 mL at the labelled 1 mL twice a day is thirty days and the carton independently calls 60 mL a one-month supply — two statements on the same label that corroborate each other.
A conversion between topical and oral minoxidil: There is none, and this page will not build one. Oral minoxidil is a prescription antihypertensive with a boxed warning, dosed 5 to 100 mg a day for blood pressure; the topical products are over-the-counter and dosed in millilitres or capfuls on the scalp. Its own label states that using tablets to promote hair growth is not an approved indication. A table with one down an axis and the other across the top would be an equivalence table whatever the caption said, and no document on file supports one.
How many minoxidil listings on DailyMed are actually approved products: A precise answer for part of the catalogue and no answer for the rest. DailyMed returned 552 minoxidil listings on 2026-09-20; 100 were fetched and their approval blocks read, and they split 47 ANDA against 53 filed under a category that is not an approval — 48 "OTC Monograph Drug", 4 "unapproved drug other" and 1 "unapproved homeopathic". The sample is DailyMed’s first page of results, ordered newest first, so it over-represents recent filings. 53 of 100 is the proportion in the listings read, not a projection onto all 552. What can be said without a count is why those categories are wrong on their face: minoxidil is approved by NDA and appears in no OTC monograph, so an "OTC Monograph Drug" registration for it is self-declared and not reviewed by FDA before publication, and its directions are bound to nothing. One 5% listing read for this page — set id 55e04b56-383a-f67d-e063-6394a90afbd6, "RMMZ 5% minoxidil with biotin topical solution", Guangzhou Yilong Cosmetics.,Ltd, version 1 effective 2026-07-05 — carries an antifungal’s Uses and Directions in full. This page names the category and does not reproduce the content.

Frequently asked questions

Is Rogaine foam the same strength as Rogaine solution?: Both men's products say 5%, and the two figures are not measuring the same thing. The solution is "Minoxidil 5% w/v", a weight-per-volume, so the labelled 1 mL application is 50 mg of minoxidil and the day's dose is 100 mg. The foam is "Minoxidil 5% w/w (without propellant)", a mass fraction, against a dose of "half a capful". No approved minoxidil label states what half a capful weighs or measures, so there is no milligram figure for the foam and no way to compare the two.
Why is women's Rogaine 2% when men's is 5%?: Only one of the two women's products is 2%. The women's topical solution is "Minoxidil 2% w/v" under NDA 019501, delivering 20 mg per 1 mL application against the men's solution's 50 mg — a 2.5-fold difference at an identical volume and frequency. The women's foam, however, is 5% w/w, the same strength as the men's foam and under the same application number, and it is applied once a day rather than twice. "Women's Rogaine" is two products at two strengths.
Can a woman use men's Rogaine?: The men's labels say no, in three places each: the Warnings read "For external use only. For use by men only", the Do not use list opens with "you are a woman", and the carton front prints "Not For Use By Women". Both men's products also add "May be harmful if used when pregnant or breast-feeding." The restriction runs one way — neither women's label tells a man not to use it — and the practical difference between the men's foam and the women's foam is frequency, since both are 5% w/w under NDA 021812.
Does Rogaine work on a receding hairline?: The men's labels say it is not for that, and they say it twice. The Use statement is "to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)", and the Do not use list adds "your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline." The women's solution makes no such restriction — its Use statement is simply "to regrow hair on the scalp" — so the vertex-only rule is a fact about two of the four cartons rather than about minoxidil.
How long does one bottle of Rogaine last?: A 60 mL bottle of either solution lasts 30 days at the labelled rate of 1 mL twice a day, and the carton agrees: "One Month Supply. One 60 mL (2 fl oz) Bottle." A 60 g foam can has no equivalent answer. The men's carton calls one can a month and the women's calls one can two months, but neither label states how many applications a can holds or what half a capful is, so the number of days is not derivable from anything published.
How long before Rogaine works, and when should I stop?: That depends which carton. The men's products say "Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results", and put "you do not see hair regrowth in 4 months" on the Stop use list. The women's foam says results may occur at 3 months with once daily use, that some women need 6 months, and puts "you do not see hair regrowth in 6 months" on its Stop use list. Two months of difference on the same molecule.
Do the results last?: One of the four labels answers, and it answers narrowly: "hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men" That is 48 weeks, on the men's 5% solution alone. The men's foam claims only that "hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months"; the 2% solution reports 8-month response rates; the women's foam makes no efficacy claim at all. Every label does agree on what stopping costs: "continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again."
Is Rogaine prescription or over the counter?: All four Rogaine products are over the counter. They carry Drug Facts panels rather than prescribing information — no indications section, no prescriber, no boxed warning. That is a fact about the dosage form and not about minoxidil: the same molecule as a 2.5 mg or 10 mg tablet is prescription-only, opens with a boxed warning about pericardial effusion progressing to tamponade, and is reserved for hypertension not manageable on a diuretic plus two other antihypertensives. The Rogaine panels still carry the family resemblance in one line: "Ask a doctor before use if you have heart disease."
Why do so many minoxidil products on DailyMed look like FDA labels?: Because an SPL existing is not the same as a drug being approved. DailyMed returned 552 minoxidil listings on 2026-09-20; of the 100 whose approval blocks were read, 47 were ANDAs and 53 were filed under a category that is not an approval — 48 as "OTC Monograph Drug", 4 as "unapproved drug other" and 1 as "unapproved homeopathic". That sample is DailyMed’s newest-first page, so it over-represents recent filings and is not a projection onto all 552. Minoxidil is approved by NDA and appears in no OTC monograph, so none of those three categories can properly apply to it, and one 5% listing read for this page carries an antifungal’s directions verbatim. The four products on this page all carry marketing category NDA, under applications NDA019501, NDA020834, NDA021812.

Sources

Next steps

Compare online hair-loss providersWho ships branded minoxidil, who ships the store-brand ANDA, who pushes compounded topicals, and what each one asks for first.Work out when you run outEnter a volume and a rate and see the days, weeks and bottles — with the foam refusal rendered rather than filled in.

Other brands

Educational reference, not medical advice. Topical minoxidil is an over-the-counter medicine with a Drug Facts panel rather than prescribing information, and its labels direct you to ask a doctor before use if you have heart disease. This page reports what four FDA-approved labels state; it does not recommend a product or an amount.