Brand — two products, two applications, one name
AndroGel
Two separately approved gels are sold as AndroGel. One permits the abdomen and one forbids it, one pump press is 12.5 mg or 20.25 mg depending which you hold, and four presses is the starting dose of one product and the maximum of the other.
- Molecule
- testosterone
- Manufacturer
- ASCEND Therapeutics U.S., LLC
- Products under this name
- 2
- Last reviewed
Why "four pumps of AndroGel" is not a dose
AndroGel is two medicines. AndroGel 1% holds NDA 021015 and AndroGel 1.62% holds NDA 022309, and each label opens its dosage section by pointing at the other: "Dosage and Administration for AndroGel 1% differs from AndroGel 1.62%. For dosage and administration of AndroGel 1.62% refer to its full prescribing information." They are dispensed in canisters of the same size, primed the same way with three discarded presses, and applied once daily in the morning. What differs is what a press is worth. One actuation of the 1% delivers 12.5 mg of testosterone in 1.25 g of gel; one actuation of the 1.62% delivers 20.25 mg in the same 1.25 g. Four presses is therefore 50 mg on one product and 81 mg on the other — which happens to be the starting dose of the first and the labelled maximum of the second.
The site instruction diverges in the same way and is easier to get wrong, because it reads like a general fact about testosterone gel. AndroGel 1% permits the abdomen: "AndroGel 1% should be applied to clean, dry, healthy, intact skin of the right and left upper arms/shoulders and/or right and left abdomen." AndroGel 1.62% prohibits it by name: "Do not apply AndroGel 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees." That is not a drafting accident. Section 12.3 of the 1.62% label reports a transfer study in which men applied 81 mg "to abdomen only for 7 days, a site of application not approved for AndroGel 1.62%", and their female partners' mean testosterone rose 60% by day seven despite the site being covered by a T-shirt. Then the wait before water differs too: 5 hours on the 1% against 2 on the 1.62%.
None of this is a property of testosterone. The molecule has no application site, no milligrams per actuation and no swimming interval; each belongs to a product, and the two labels say so in the indications section itself — "Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure." Both then close section 2.1 with the same sentence against exactly this confusion: "The application site and dose of AndroGel 1% are not substitutable with other topical testosterone products."
What is true of AndroGel and not of testosterone
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 | AndroGel | Elsewhere, same molecule |
|---|---|---|
| Whether the abdomen is an allowed application siteA man switched between the two AndroGel products at the same milligram dose can be following his old instructions onto a site his new label prohibits. The 1.62% label measured what happens: applied to the abdomen for seven days, female partners' testosterone rose 60% by day 7 even with the site covered by a T-shirt — against 6% on a covered shoulder. | AndroGel 1% permits it: "AndroGel 1% should be applied to clean, dry, healthy, intact skin of the right and left upper arms/shoulders and/or right and left abdomen." Its prohibited list — genitals, chest, armpits, knees, back — does not include the abdomen. | AndroGel 1.62% forbids it by name: "Do not apply AndroGel 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees." So do TESTIM ("Do not apply TESTIM to the genitals or to the abdomen") and Vogelxo ("Do not apply Vogelxo to the genitals or abdomen"). AndroGel 1% is the only one of the four that permits it. |
| What one pump actuation deliversFour presses is 50 mg on the 1% and 81 mg on the 1.62%, which is the starting dose of one product and the labelled maximum of the other. An instruction expressed in presses rather than milligrams does not survive a switch, and neither does one expressed in packets: no packet size is shared between the two. | AndroGel 1%: 12.5 mg of testosterone in 1.25 g of gel, 60 actuations to a canister, 750 mg in total. | AndroGel 1.62%: 20.25 mg in the same 1.25 g of gel, the same 60 actuations, 1215 mg in total — 62% more drug from an identically sized canister. |
| How long to wait before swimming or showering5 hours against 2. A man who applies at 7 am and swims at 10 has complied with one label and broken the other, and there is nothing on the carton of either that would prompt him to check which one he has. | AndroGel 1%: "The patient should be advised to avoid swimming or showering for at least 5 hours after the application of AndroGel 1%." | AndroGel 1.62%: "The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application." Its section 12.3 supports the shorter figure with data — showering at 2 hours cost 13% of mean Cavg, at 10 hours nothing. |
| The dose range and how it is titratedTwo products of one brand with different step sizes, different numbers of rungs, different target definitions and different monitoring calendars. A 1.62% patient has two scheduled blood draws in his first month; a 1% patient has none the label names. | AndroGel 1%: three doses, 50, 75 and 100 mg, in 25 mg steps, against "the normal range" with no numeric window and no day named for the level. It carries a stop rule the other does not: "If the serum testosterone concentration consistently exceeds the normal range at a daily dose of 50 mg, AndroGel 1% therapy should be discontinued." | AndroGel 1.62%: four doses, 20.25 mg, 40.5 mg, 60.75 mg, 81 mg, in 20.25 mg steps, against a stated window — decrease above 750 ng/dL, no change between 350 and 750, increase below 350 — with the level drawn "at approximately 14 days and 28 days after starting treatment or following dose adjustment". |
| Who the boxed warning namesA box on a testosterone product describes its delivery system, not the hormone. The gel box exists because the drug is on skin someone else can touch, and it disappears the moment the same molecule goes up a nose or into a muscle. Reading "testosterone has a boxed warning about children" back onto an injection or a capsule imports a risk those products do not have. | Children, and only children. Both products open with "Virilization has been reported in children who were secondarily exposed to testosterone gel" and "Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel." Women are elsewhere — 5.1 says "Avoid unintentional exposure of women or children", and 17.2 lists their signs separately: "In women: changes in hair distribution, increase in acne, or other signs of testosterone effects." | NATESTO, the same molecule as an intranasal gel (NDA 205488), carries no boxed warning at all — 11 mg three times daily into the nostrils, 33 mg a day, with no application site to transfer from. AVEED, the intramuscular undecanoate, is boxed for something else entirely: pulmonary oil microembolism and anaphylaxis, with 30 minutes of observation after every dose and a REMS. |
| Which product the blood-pressure figure belongs toThere is no ambulatory blood pressure figure for AndroGel 1% anywhere in its label. The number a prescriber would read off section 5.5 and attribute to the 1% gel was generated on the 1.62% one. This page states the figure with the product it belongs to and refuses to restate it as the 1%'s, which is the whole of the omission below. | Both labels print the same number and it is the 1.62% product's: an ABPM study showing +1.9/1.3 mm Hg from baseline after 16 weeks of treatment, rising to 3.0/2.2 mm Hg in men already on antihypertensives. Section 5.5 of the AndroGel 1% label opens "AndroGel 1% can increase blood pressure" and then attributes every figure, the TRAVERSE result and the closing recommendation to AndroGel 1.62%. | JATENZO states its own: +4.9/2.5 mm Hg at four months, with "Average blood pressures had not plateaued at the end of the trial." XYOSTED states its own: +3.9/1.5 mm Hg at 12 weeks. TLANDO: +4.3/1.4 mm Hg at approximately 16 weeks. Each of those is that product's own study. |
| Whether the label forbids substituting another gelThe non-substitution warning is not a class rule; it is on three topical labels of the five read here. Its absence from Vogelxo does not license substituting Vogelxo for anything, but its presence on AndroGel does mean the manufacturer has been asked this question and answered it, and the answer is in section 2.1 of both products. | Both AndroGel products carry it, each naming itself: "The application site and dose of AndroGel 1% are not substitutable with other topical testosterone products." and "The application site and dose of AndroGel 1.62% are not substitutable with other topical testosterone products." | TESTIM carries the same sentence about itself. Vogelxo — which shares TESTIM's 50 mg starting dose, its 100 mg maximum, its shoulders-and-upper-arms-only site and its one-tube unit — does not carry it at all, and neither does NATESTO. |
| The packets, and whether any is a whole doseNo packet size is shared between the two products, and the 1.62% packets are smaller in gel while larger in drug. A prescription written as "one packet daily" is unresolvable without the strength, and a patient handed the wrong box has no cue from the sachet size that anything has changed. | AndroGel 1%: 25 mg in 2.5 g and 50 mg in 5 g. Only the 50 mg packet is a labelled dose on its own; the 25 mg packet exists to be used two at a time. | AndroGel 1.62%: 20.25 mg in 1.25 g and 40.5 mg in 2.5 g. Both are labelled doses on their own — 20.25 mg is the minimum and 40.5 mg the starting dose — and two 40.5 mg packets make the 81 mg maximum. |
Boxed warning — secondary exposure to testosterone. It names children, and only children
Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)]. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)]. Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration (2.2), Warnings and Precautions (5.1) and Patient Counseling Information (17)].
Quoted from the boxed warning on the approved product label. See the full prescribing information for the complete warning.
AndroGel 1%
- Dosage form
- Gel, 1%, for topical use — CIII
- Route
- Topical, once daily in the morning, to the upper arms/shoulders and/or abdomen
- Marketing category
- NDA — NDA021015
- Label read
- SPL version 140, effective July 31, 2025
What this product is approved to treat
- —AndroGel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism (congenital or acquired).
- —Limitation of use: "Safety and efficacy of AndroGel 1% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established."
- —Limitation of use: "Safety and efficacy of AndroGel 1% in males less than 18 years old have not been established."
- —Limitation of use, and the one that makes this page necessary: "Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure." That sentence is in section 1, the indications section, not buried in a warning.
The labelled ladder
| When | Dose | What the label attaches to this step |
|---|---|---|
| Before the first dose | None | "Prior to initiating AndroGel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range." |
| Starting dose | 50 mg once daily in the morning | 4 pump actuations at 12.5 mg each, or two 25 mg packets, or one 50 mg packet. Section 2.1: "The recommended starting dose of AndroGel 1% is 50 mg of testosterone". |
| Titration step | 75 mg once daily in the morning | 6 pump actuations at 12.5 mg each. |
| Maximum the label names | 100 mg once daily in the morning | 8 pump actuations at 12.5 mg each. Nothing above 100 mg is named for this product. |
| Titration | Adjusted on a serum level | To ensure proper dosing, serum testosterone concentrations should be measured at intervals. — section 2.1 names no day. If the concentration is below the normal range the daily dose may be increased from 50 mg to 75 mg and from 75 mg to 100 mg. "If the serum testosterone concentration consistently exceeds the normal range at a daily dose of 50 mg, AndroGel 1% therapy should be discontinued." — the label's only stop rule, and it has no counterpart on the 1.62%. |
| Every application, for as long as treatment continues | Unchanged | AndroGel 1% should be applied to clean, dry, healthy, intact skin of the right and left upper arms/shoulders and/or right and left abdomen. Do not apply AndroGel 1% to any other part of the body including the genitals, chest, armpits (axillae), knees, or back. "The patient should avoid swimming or showering for at least 5 hours after the application of AndroGel 1%." |
Ceiling. The label names 100 mg once daily as the top of its three-dose range — "the daily AndroGel 1% dose may be increased from 50 mg to 75 mg and from 75 mg to 100 mg for adult males as instructed by the physician" — which is 8 pump actuations. It does not use the phrase "maximum recommended dose"; TESTIM and Vogelxo, which share the 50 mg starting dose, both do. The 1.62% product's maximum is 81 mg, a lower number of milligrams reached in fewer presses.
How it is supplied
| Presentation | Total strength | Concentration | Delivers |
|---|---|---|---|
| Metered-dose pump, 88 g canister — 60 metered actuations after priming | 750 mg of testosterone per full pump | 1% gel — 12.5 mg of testosterone in 1.25 g of gel per actuation | Prime with three discarded actuations before the first dose, then one press per 12.5 mg. Four presses is 50 mg on this product. |
| Unit-dose foil packet, cartons of 30 — 2.5 g of gel | 25 mg of testosterone | 1% gel | Not a whole labelled dose on its own; the 50 mg starting dose is two of these. No packet size is shared with the other AndroGel product. |
| Unit-dose foil packet, cartons of 30 — 5 g of gel | 50 mg of testosterone | 1% gel | A whole labelled dose on its own (50 mg once daily). No packet size is shared with the other AndroGel product. |
Administration, as the label words it
- —Section 2.2: "AndroGel 1% should be applied to clean, dry, healthy, intact skin of the right and left upper arms/shoulders and/or right and left abdomen." And: "Do not apply AndroGel 1% to any other part of the body including the genitals, chest, armpits (axillae), knees, or back."
- —"Area of application should be limited to the area that will be covered by the patient's short sleeve t-shirt."
- —"The patient should be advised to avoid swimming or showering for at least 5 hours after the application of AndroGel 1%."
- —Section 2.1, closing sentence: "The application site and dose of AndroGel 1% are not substitutable with other topical testosterone products."
- —"After applying the gel, the application site should be allowed to dry prior to dressing. Hands should be washed thoroughly with soap and water after application. Avoid fire, flames or smoking until the gel has dried since alcohol-based products, including AndroGel, are flammable."
- —Secondary-exposure precautions, section 2.2: "Children and women should avoid contact with unwashed or unclothed application site(s) of men using AndroGel." "Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried." "Prior to situation in which direct skin-to-skin contact is anticipated, patients should wash the application site thoroughly with soap and water to remove any testosterone residue."
- —"In the event that unwashed or unclothed skin to which AndroGel has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible."
- —Section 5.5, blood pressure: "Androgel 1.62% is not recommended for use in patients with uncontrolled hypertension." Note the product named — see the omission below.
- —Section 2.1 dose options: "50 mg of testosterone (4 pump actuations, two 25 mg packets or one 50 mg packet)", rising to 75 mg (6 actuations) and 100 mg (8 actuations).
- —Section 12.3, transfer: in 38 couples, two to twelve hours after a 100 mg application "all unprotected female partners had a serum testosterone concentration >2 times the baseline value at some time during the study. When a shirt covered the application site(s), the transfer of testosterone from the males to the female partners was completely prevented."
Storage
- Pump or packets
- "Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [see USP Controlled Room Temperature]." Alcohol-based and flammable: keep away from fire and flame until dry.
- Until the expiration date; no in-use period is stated
- Empty pumps and used packets
- Disposal is a labelled instruction rather than an afterthought: "Used AndroGel pumps or used AndroGel packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets."
- Dispose of immediately after use
Children and adolescents
"Safety and efficacy of AndroGel 1% in males less than 18 years old have not been established", stated as a Limitation of Use in section 1 and repeated at 8.4. The boxed warning runs the other way as well: children are the population the box exists to protect, not to treat — "Virilization has been reported in children who were secondarily exposed to testosterone gel", with postmarketing cases of enlarged genitalia, pubic hair, increased erections and advanced bone age, some of which did not fully resolve.
This statement belongs to AndroGel 1%. It is not a statement about testosterone, and another brand of the same molecule may say the opposite.
AndroGel 1.62%
- Dosage form
- Gel, 1.62%, for topical use — CIII
- Route
- Topical, once daily in the morning, to the upper arms and shoulders only
- Marketing category
- NDA — NDA022309
- Label read
- SPL version 130, effective October 22, 2025
What this product is approved to treat
- —AndroGel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism (congenital or acquired).
- —Limitation of use: "Safety and efficacy of AndroGel 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established."
- —Limitation of use: "Safety and efficacy of AndroGel 1.62% in males less than 18 years old have not been established."
- —Limitation of use, and the one that makes this page necessary: "Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure." That sentence is in section 1, the indications section, not buried in a warning.
The labelled ladder
| When | Dose | What the label attaches to this step |
|---|---|---|
| Before the first dose | None | "Prior to initiating AndroGel 1.62%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range." |
| Minimum the label names | 20.25 mg once daily in the morning | 1 pump actuation at 20.25 mg each, or a single 20.25 mg packet. |
| Starting dose | 40.5 mg once daily in the morning | 2 pump actuations at 20.25 mg each, or a single 40.5 mg packet. Section 2.1: "The recommended starting dose of AndroGel 1.62% is 40.5 mg of testosterone". |
| Titration step | 60.75 mg once daily in the morning | 3 pump actuations at 20.25 mg each. |
| Maximum the label names | 81 mg once daily in the morning | 4 pump actuations at 20.25 mg each, or two 40.5 mg packets. Nothing above 81 mg is named for this product. |
| Titration | Adjusted on a serum level | the dose should be titrated based on the pre-dose morning serum testosterone concentration from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment Above 750 ng/dL, decrease the daily dose by 20.25 mg. Between 350 and 750 ng/dL, no change. Below 350 ng/dL, increase by 20.25 mg. The 1.62% label sets a numeric window; the 1% label says only "the normal range". |
| Every application, for as long as treatment continues | Unchanged | AndroGel 1.62% should be applied to clean, dry, intact skin of the upper arms and shoulders. Do not apply AndroGel 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees. "The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application." |
Ceiling. Section 2.1 states it explicitly: the dose "can be adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation or a single 20.25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets)". Eighty-one milligrams is four presses of this pump — the same number of presses that gives the AndroGel 1% product its 50 mg STARTING dose.
How it is supplied
| Presentation | Total strength | Concentration | Delivers |
|---|---|---|---|
| Metered-dose pump, 88 g canister — 60 metered actuations after priming | 1215 mg of testosterone per full pump | 1.62% gel — 20.25 mg of testosterone in 1.25 g of gel per actuation | Prime with three discarded actuations before the first dose, then one press per 20.25 mg. Four presses is 81 mg on this product. |
| Unit-dose foil packet, cartons of 30 — 1.25 g of gel | 20.25 mg of testosterone | 1.62% gel | A whole labelled dose on its own (20.25 mg once daily). No packet size is shared with the other AndroGel product. |
| Unit-dose foil packet, cartons of 30 — 2.5 g of gel | 40.5 mg of testosterone | 1.62% gel | A whole labelled dose on its own (40.5 mg once daily). No packet size is shared with the other AndroGel product. |
Administration, as the label words it
- —Section 2.2: "AndroGel 1.62% should be applied to clean, dry, intact skin of the upper arms and shoulders." And: "Do not apply AndroGel 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees."
- —"Area of application should be limited to the area that will be covered by the patient's short sleeve t-shirt."
- —"The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application."
- —Section 2.1, closing sentence: "The application site and dose of AndroGel 1.62% are not substitutable with other topical testosterone products."
- —"After applying the gel, the application site should be allowed to dry prior to dressing. Hands should be washed thoroughly with soap and water after application. Avoid fire, flames or smoking until the gel has dried since alcohol-based products, including AndroGel, are flammable."
- —Secondary-exposure precautions, section 2.2: "Children and women should avoid contact with unwashed or unclothed application site(s) of men using AndroGel." "Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried." "Prior to situation in which direct skin-to-skin contact is anticipated, patients should wash the application site thoroughly with soap and water to remove any testosterone residue."
- —"In the event that unwashed or unclothed skin to which AndroGel has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible."
- —Section 5.5, blood pressure: "Androgel 1.62% is not recommended for use in patients with uncontrolled hypertension." Note the product named — see the omission below.
- —Section 2.1 dose options: 20.25 mg (1 actuation or one 20.25 mg packet), 40.5 mg (2 actuations or one 40.5 mg packet), 60.75 mg (3 actuations) and 81 mg (4 actuations or two 40.5 mg packets).
- —Section 12.3, transfer at the approved site: after skin-to-skin contact with an uncovered shoulder two hours post-dose, mean testosterone in female subjects rose 280% (Cavg) and 267% (Cmax); with a T-shirt covering the site, 6% and 11%.
- —Section 12.3, transfer at a site this product is not approved for: applied "to abdomen only for 7 days, a site of application not approved for AndroGel 1.62%", with the area covered by a T-shirt, female partners' mean testosterone rose 43% (Cavg) on day 1 and 60% by day 7 — the shirt did not do on the abdomen what it did on the shoulder.
- —Section 12.3, showering: after 7 days at 81 mg, showering at 2 or 6 hours post-dose reduced mean Cavg by 13% and 12%; "Showering at 10 hours after drug application had no effect on bioavailability."
Storage
- Pump or packets
- "Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [see USP Controlled Room Temperature]." Alcohol-based and flammable: keep away from fire and flame until dry.
- Until the expiration date; no in-use period is stated
- Empty pumps and used packets
- Disposal is a labelled instruction rather than an afterthought: "Used AndroGel pumps or used AndroGel packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets."
- Dispose of immediately after use
Children and adolescents
"Safety and efficacy of AndroGel 1.62% in males less than 18 years old have not been established", stated as a Limitation of Use in section 1 and repeated at 8.4. The boxed warning runs the other way as well: children are the population the box exists to protect, not to treat — "Virilization has been reported in children who were secondarily exposed to testosterone gel", with postmarketing cases of enlarged genitalia, pubic hair, increased erections and advanced bone age, some of which did not fully resolve.
This statement belongs to AndroGel 1.62%. It is not a statement about testosterone, and another brand of the same molecule may say the opposite.
The same molecule under other brand names
Everything below is testosterone. None of it is AndroGel, 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 |
|---|---|---|---|---|
| Natesto | Intranasal gel, metered pump — 5.5 mg of testosterone per actuation, NDA 205488 | Replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. No boxed warning — there is no application site for anyone else to touch | 11 mg (2 actuations, one per nostril) three times daily — 33 mg a day total | No dose above 11 mg three times daily is named; discontinue if total testosterone consistently exceeds 1050 ng/dL |
| Testim | Topical gel 1%, 50 mg per one-tube dose — NDA 021454 | The same two hypogonadism indications. Boxed for secondary exposure, like AndroGel; abdomen prohibited, unlike AndroGel 1% | 50 mg once daily → 100 mg if the pre-dose level is below normal | The maximum recommended dose of TESTIM is 100 mg once daily |
| Vogelxo | Topical gel 1% — tube, packet or metered pump, 50 mg per dose — NDA 204399 | The same two indications, boxed for secondary exposure, abdomen and genitals prohibited. Carries no non-substitution sentence | 50 mg once daily → 100 mg if the pre-dose level is below normal | The maximum recommended dose of Vogelxo is 100 mg once daily |
Switching between products
Section 2.1 closes by ruling out the substitution
The application site and dose of AndroGel 1% are not substitutable with other topical testosterone products.
AndroGel 1%
The same sentence, naming the other product
The application site and dose of AndroGel 1.62% are not substitutable with other topical testosterone products.
AndroGel 1.62%
The warning is in section 1, not buried in a precaution
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.
Both, in the indications section
Each label sends you to the other rather than covering it
Dosage and Administration for AndroGel 1% differs from AndroGel 1.62%. For dosage and administration of AndroGel 1.62% refer to its full prescribing information.
Both, opening the dosage section
What this page does not tell you
- Price — list, cash or copay
- No price appears anywhere on this page, and no price is emitted in its structured data. AndroGel is dispensed as a brand and as authorised and independent generics, in pumps and in two packet sizes per strength, with copay assistance and pharmacy discount programmes that move the number a patient actually pays by a multiple. We could find no source for a current US figure that we could cite and re-verify the way every label quote here is cited, so the field is absent rather than estimated.
- An ambulatory blood pressure figure for AndroGel 1%
- There is not one, anywhere in its label, and this page will not borrow the other product's. Section 5.5 of the AndroGel 1% prescribing information opens "AndroGel 1% can increase blood pressure" and then gives every subsequent figure for AndroGel 1.62% — +1.9/1.3 mm Hg from baseline after 16 weeks of treatment, 3.0/2.2 mm Hg in men on antihypertensives, and the TRAVERSE systolic difference of 1.5 mm Hg — before closing with "Androgel 1.62% is not recommended for use in patients with uncontrolled hypertension." A reader looking up the 1% product's blood pressure effect will find a number that belongs to a gel with 62% more drug per actuation and a different approved application site. The recommendation applies to both; the number is one product's.
- What NDC 17139-550-30 actually contains
- The current AndroGel 1% label contradicts itself here, so this page states the conflict rather than picking a side. The HOW SUPPLIED prose reads "Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, respectively", and the table two lines below describes NDC 17139-550-30 as "30 packets (each unit dose packet contains 20.25 mg of testosterone provided in 1.25 g of gel)" — which is the AndroGel 1.62% packet specification. It cannot be right for a 1% gel: the structured product data for that same NDC records 10 mg of testosterone per gram, so 1.25 g is 12.5 mg, not 20.25 mg. The tables on this page use the section 3 and prose figures, 25 mg in 2.5 g and 50 mg in 5 g, and anyone checking a dispensed packet against a label should check the packet.
- A conversion between the 1% and the 1.62%
- Both labels forbid it in section 2.1 and this page does not supply one. It is technically possible to write "50 mg of the 1% is 50 mg of the 1.62%" and technically wrong for the only reason that matters: the two products were titrated against different targets, at different application sites, with different absorption, and the 1.62% cannot make 50 mg in whole pump actuations at all. The nearest honest statement is the one the labels make — that topical testosterone products "may have different doses, strengths, or application instructions that may result in different systemic exposure" — and that a switch is a new titration rather than an arithmetic conversion.
Frequently asked questions
- What is the difference between AndroGel 1% and 1.62%?
- They are two separately approved products, NDA 021015 and NDA 022309, and they disagree on three things. One pump actuation is 12.5 mg of the 1% and 20.25 mg of the 1.62%. The 1% may be applied to the shoulders, upper arms and/or abdomen; the 1.62% prohibits the abdomen by name. And the wait before swimming or showering is 5 hours on the 1% against 2 on the 1.62%. The dose ranges differ too: 50 to 100 mg in 25 mg steps against 20.25 to 81 mg in 20.25 mg steps.
- How many pumps of AndroGel is a dose?
- Only answerable once you know which product. Four presses is 50 mg of AndroGel 1% — the starting dose — and 81 mg of AndroGel 1.62%, which is that product's labelled maximum. The 1.62% starting dose is 40.5 mg, which is two presses. Both pumps must be primed with three discarded actuations before the first dose, and both canisters give 60 metered actuations after priming, so a full 1% pump holds 750 mg and a full 1.62% pump holds 1215 mg.
- Can I apply AndroGel to my stomach?
- Depends which one. AndroGel 1%: "AndroGel 1% should be applied to clean, dry, healthy, intact skin of the right and left upper arms/shoulders and/or right and left abdomen." AndroGel 1.62%: "Do not apply AndroGel 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees." TESTIM and Vogelxo also prohibit the abdomen, so AndroGel 1% is the outlier among the topical gels rather than the rule. The 1.62% label explains itself in section 12.3: in a study where men applied 81 mg to the abdomen only for seven days with the site covered by a T-shirt, their female partners' mean testosterone rose 43% on day 1 and 60% by day 7 — where a covered shoulder produced a 6% rise.
- How long after applying AndroGel can I shower or swim?
- Five hours on AndroGel 1% and two on AndroGel 1.62%, each stated in its own section 2.2. The 1.62% label has the data behind it: after seven days at 81 mg, showering at 2 or 6 hours post-dose reduced mean concentration by 13% and 12% respectively, while "Showering at 10 hours after drug application had no effect on bioavailability." Tape-stripping showed the testosterone remaining in the outer skin at the site was reduced by at least 80% after any shower between 2 and 10 hours.
- Does the AndroGel boxed warning cover women?
- Not the box itself. The boxed warning names children three times and women not at all: "Virilization has been reported in children who were secondarily exposed to testosterone gel" and "Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel." Women appear outside the box — section 5.1 directs avoiding "unintentional exposure of women or children", and section 17.2 lists what to watch for in each group separately, giving women "changes in hair distribution, increase in acne, or other signs of testosterone effects". The transfer studies in section 12.3 were run in female partners, and a T-shirt over a shoulder cut the rise from 280% to 6%.
- How much does AndroGel raise blood pressure?
- There is a figure for the 1.62% and none for the 1%, and this page keeps them apart. An ambulatory monitoring study of AndroGel 1.62% found a mean rise of +1.9/1.3 mm Hg from baseline after 16 weeks of treatment, and 3.0/2.2 mm Hg in men already on antihypertensive therapy. Section 5.5 of the AndroGel 1% label repeats those same 1.62% numbers under a heading about the 1% and never gives one of its own. For comparison, the oral and subcutaneous products state larger figures for themselves: JATENZO +4.9/2.5 mm Hg at four months, TLANDO +4.3/1.4 at about 16 weeks, XYOSTED +3.9/1.5 at 12 weeks. Both AndroGel labels close with the same instruction: not recommended in uncontrolled hypertension.
- Is AndroGel approved for low testosterone caused by age?
- No. Both labels carry it as a Limitation of Use in section 1: "Safety and efficacy of AndroGel in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established." The approved indications are primary hypogonadism and hypogonadotropic hypogonadism — testicular failure from causes such as cryptorchidism, torsion, orchitis, orchiectomy, Klinefelter's syndrome, chemotherapy or heavy-metal damage, or gonadotropin and LHRH deficiency from pituitary-hypothalamic injury. Males under 18 are a second limitation on both products.
- Can I switch between AndroGel and Testim or Vogelxo at the same milligrams?
- Three of those four labels say no in the same words. AndroGel 1%, AndroGel 1.62% and TESTIM each close section 2.1 with "The application site and dose of [this product] are not substitutable with other topical testosterone products"; Vogelxo carries no such sentence. Testim and Vogelxo do share AndroGel 1%'s 50 mg starting dose and 100 mg maximum, but both prohibit the abdomen where AndroGel 1% permits it, and Testim is a single 50 mg tube rather than a countable actuation. A switch is a new titration, not a conversion.
Sources
- [1]FDA label — ANDROGEL (testosterone) gel 1%, for topical use, ASCEND Therapeutics U.S., LLC. DailyMed SPL version 140, effective 2025-07-31, marketing category NDA, application NDA021015
- [2]FDA label — ANDROGEL (testosterone) gel 1.62%, for topical use, ASCEND Therapeutics U.S., LLC. DailyMed SPL version 130, effective 2025-10-22, marketing category NDA, application NDA022309
- [3]FDA label — NATESTO (testosterone) nasal gel, Aytu BioScience, Inc. DailyMed, marketing category NDA, application NDA205488 — cited for the 5.5 mg per actuation, the 11 mg three times daily schedule and the absence of any boxed warning
- [4]FDA label — TESTIM (testosterone) gel, Endo USA, Inc. DailyMed SPL version 29, effective 2025-07-15, marketing category NDA, application NDA021454 — cited for the 50 mg starting dose, the 100 mg maximum, the abdomen prohibition and the non-substitution sentence
- [5]FDA label — VOGELXO (testosterone) gel and gel, metered, Upsher-Smith Laboratories, LLC. DailyMed SPL version 13, effective 2025-07-14, marketing category NDA, application NDA204399 — cited for the identical 50 mg/100 mg range, the abdomen prohibition and the absence of a non-substitution sentence
Next steps
- Testosterone gel: the compound reference
- Depo-Testosterone — the intramuscular oil
- Xyosted — the weekly subcutaneous autoinjector
- Jatenzo — the oral capsule
- Testosterone dosage chart
- Free testosterone calculator
Other brands
- Depo-TestosteroneTestosterone cypionate in cottonseed oil, 50 to 400 mg deep intramuscularly every two to four weeks, in two strengths that differ by more than concentration.
- XyostedTestosterone enanthate in a sealed single-dose autoinjector, 75 mg once weekly into the abdomen, titrated in 25 mg steps against a trough.
- JatenzoOral testosterone undecanoate in three capsule strengths, taken with food twice daily and adjusted on a level drawn six hours after the morning dose.
- OzempicA weekly injection capped at 2 mg and a daily tablet capped at 9 mg, sold under the same brand name and described in two different labels.
- WegovyA once-weekly injection and a once-daily 25 mg tablet sharing one label, one boxed warning and almost nothing else.
- MounjaroTirzepatide for type 2 diabetes and cardiovascular risk, with a conditional ladder, two maximum doses and no named maintenance dose.
Educational reference, not medical advice. Testosterone gel is a Schedule III controlled substance and a prescription-only medicine, contraindicated in pregnant women and in men with breast or suspected prostate carcinoma, and it can be transferred to another person by skin contact. This page reports what two FDA labels state; it does not recommend a product, a dose or an application site.