Adapalene and benzoyl peroxide 3 mg/g; 25 mg/g Gel — NDC 59651-604-60 (Billing 59651-0604-60)
This is a package of Adapalene and benzoyl peroxide 3 mg/g; 25 mg/g Gel from Aurobindo Pharma Limited, marketed since Jul 2026 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 59651-604-60 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 59651 labeler · 604 product · 60 package
- Package marketed since
- Jul 22, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5965160460 1
- FDA record last changed
- Aug 20, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1663745
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Peroxides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Adapalene is used to treat acne in adults and children 12 years of and older. Adapalene is in a class of medications called retinoid-like compounds. It works by stopping pimples from forming under the surface of the skin.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 59651-0604-46 59651-604-46 Main listing | 1 BOTTLE, PUMP in 1 CARTON / 45 g in 1 BOTTLE, PUMP | 2026-07-22 | — | Active |
| 59651-0604-60 You're viewing this | 1 BOTTLE, PUMP in 1 CARTON / 60 g in 1 BOTTLE, PUMP | 2026-07-22 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Adapalene and benzoyl peroxide 3 mg/g; 25 mg/g Gel?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Adapalene And Benzoyl Peroxide 3 mg/g; 25 mg/g 45802-0853-45 | Padagis | 45 g | $0.626 | AB | Availability likely | — |
| adapalene and benzoyl peroxide 3 mg/g; 25 mg/g 68308-0662-45 | Mayne | 1 bottle | $0.626 | AB | Availability likely | — |
| Adapalene and benzoyl peroxide 3 mg/g; 25 mg/g 00480-3154-45 | Teva | 1 bottle | $0.626 | AB | Availability likely | — |
| Adapalene and Benzoyl Peroxide 3 mg/g; 25 mg/g 51672-1384-04 | Sun | 1 bottle | — | AB | FDA listed | — |
| Adapalene And Benzoyl Peroxide 3 mg/g; 25 mg/g 63629-9322-01 | Bryant | 45 g | — | AB | FDA listed | — |
| epiduo forte 3 mg/g; 25 mg/g 00299-5906-00 | Galderma | 2 g | — | AB | FDA listed | — |
| Adapalene and benzoyl peroxide 3 mg/g; 25 mg/g 72578-0119-02 | Viona | 1 bottle | — | AB | FDA listed | — |
| Adapalene and benzoyl peroxide 3 mg/g; 25 mg/g 70771-1716-03 | Zydus | 1 bottle | — | AB | FDA listed | — |
| Adapalene And Benzoyl Peroxide 3 mg/g; 25 mg/g 72162-1432-02 | Bryant | 45 g | — | AB | FDA listed | — |
| Adapalene and benzoyl peroxide 3 mg/g; 25 mg/gthis 59651-0604-60 | Aurobindo | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 5F4963KLHS
A synthetic polymer created from acrylamide and sodium acryloyldimethyltaurate that thickens and stabilizes liquid or semi-solid formulations. It helps maintain consistent texture and prevents separation of ingredients in creams, gels, and lotions.
-
UNII F05Q2T2JA0
Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII 918X1OUF1E
Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
-
UNII 1S66E28KXA
Poloxamer 124 is a synthetic polymer that acts as a surfactant and solubilizer in medicines. It helps dissolve and stabilize active ingredients, particularly in liquid formulations and gels.
-
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 06XEA2VD56
Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Aurobindo Pharma Limited labeler code 59651
- Ertugliflozin L-Pyroglutamic Acid 50 kg/50kg Powder NDC 59651-598-37
- Deflazacort 6 mg Tablet NDC 59651-599-01
- Deflazacort 18 mg Tablet NDC 59651-600-30
- Deflazacort 30 mg Tablet NDC 59651-601-30
- Deflazacort 36 mg Tablet NDC 59651-602-30
- Ivacaftor Premix 38 kg/50kg Powder NDC 59651-603-37
- Paclitaxel 50 kg/50kg Powder NDC 59651-605-37
- Atorvastatin Calcium 10 mg Tablet, Film Coated NDC 59651-606-05
- Atorvastatin Calcium 20 mg Tablet, Film Coated NDC 59651-607-05
- Atorvastatin Calcium 40 mg Tablet, Film Coated NDC 59651-608-05
- Atorvastatin Calcium 80 mg Tablet, Film Coated NDC 59651-609-05
- Imatinib Mesylate 50 kg/50kg Powder NDC 59651-610-37
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Adapalene and benzoyl peroxide gel, is a combination of adapalene, a retinoid, and benzoyl peroxide and is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For topical use only. Adapalene and benzoyl peroxide gel is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of adapalene and benzoyl peroxide gel to affected areas of the face and/or trunk once daily after washing.
Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Wash hands after application as adapalene and benzoyl peroxide gel may bleach hair or colored fabrics. Avoid the eyes, lips and mucous membranes.
For topical use only Adapalene and benzoyl peroxide gel is not for oral, ophthalmic or intravaginal use. ( 2 ) Apply a thin layer of adapalene and benzoyl peroxide gel to affected areas of the face and/or trunk once daily after washing. ( 2 ) Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek).
( 2 ) Avoid the eyes, lips, and mucous membranes. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Each gram of adapalene and benzoyl peroxide gel USP contains 3 mg (0.3%) adapalene USP and 25 mg (2.5%) benzoyl peroxide USP in a homogeneous, white to very pale yellow, opaque gel. Adapalene and benzoyl peroxide gel USP is available in pumps containing 45 g or 60 g. Topical Gel, 0.3%/2.5%. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Adapalene and benzoyl peroxide gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide gel. Adapalene and benzoyl peroxide gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide gel. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity : Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of benzoyl peroxide products. ( 5.1 ) Photosensitivity : Avoid exposure to sunlight and sunlamps. Wear broad spectrum sunscreen and protective clothing when sun exposure cannot be avoided.
( 5.2 ) Skin Irritation : Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of adapalene and benzoyl peroxide gel and may necessitate discontinuation. ( 5.3 )
5.1Hypersensitivity Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with the use of benzoyl peroxide products. If a serious hypersensitivity reaction occurs, discontinue adapalene and benzoyl peroxide gel immediately and initiate appropriate therapy.
5.2Photosensitivity Avoid exposure to sunlight, including sunlamps, during the use of adapalene and benzoyl peroxide gel. Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution. Use of broad spectrum sunscreen products and protective apparel (e.g., hat) are recommended when exposure cannot be avoided.
Weather extremes, such as wind or cold, may be irritating to patients under treatment with adapalene and benzoyl peroxide gel.
5.3Skin Irritation/Contact Dermatitis Erythema, scaling, dryness, and stinging/burning may be experienced with use of adapalene and benzoyl peroxide gel. These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Irritant and allergic contact dermatitis may occur.
Depending upon the severity of these adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application of adapalene and benzoyl peroxide gel, or discontinue use. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with adapalene and benzoyl peroxide gel.
Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices or limes).
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥1%) are skin irritation, eczema, atopic dermatitis and skin burning sensation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience The following adverse reactions are discussed in greater detail elsewhere in the labeling: • Hypersensitivity [see Warnings and Precautions (5.1) ] • Skin Irritation/Contact Dermatitis [see Warnings and Precautions (5.3) ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During the randomized, double-blind, vehicle- and active-controlled clinical trial, 217 subjects were exposed to adapalene and benzoyl peroxide gel.
A total of 197 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Adverse reactions reported within 12 weeks of treatment in at least 1% of subjects treated with adapalene and benzoyl peroxide gel and for which the rate with adapalene and benzoyl peroxide gel exceeded the rate for the vehicle are presented in Table 1: Table 1. Adverse Reactions Occurring in ≥1% of Subjects with Acne Vulgaris in a 12-week Clinical Trial Adapalene and Benzoyl Peroxide Gel (N=217) Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=217) Vehicle (N=69) Skin irritation 4% <1% 0% Eczema 1% 0% 0% Dermatitis atopic 1% 0% 0% Skin burning sensation 1% 0% 0% Local tolerability evaluations presented in Table 2, were conducted at each trial visit in the clinical trial by assessment of erythema, scaling, dryness, and stinging/burning, which peaked at Week 1 of therapy and decreased thereafter.
Table 2. Incidence of Local Cutaneous Irritation in 12-week Clinical Trial in Subjects with Acne Vulgaris Maximum Severity During Treatment End of Treatment Severity (Final Score) Moderate Severe Moderate Severe Adapalene and Benzoyl Peroxide Gel (N=213) Erythema 20% 1% 4% <1% Scaling 17% 1% 1% <1% Dryness 15% 2% 3% <1% Stinging/burning 19% 6% 1% 1% Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=212) Erythema 15% 1% 2% <1% Scaling 12% <1% 2% 0% Dryness 13% 1% 2% 0% Stinging/burning 14% 9% 3% 0% Vehicle (N=68) Erythema 6% 1% 1% 0% Scaling 6% 0% 1% 0% Dryness 4% 1% 1% 0% Stinging/burning 3% 1% 0% 0%
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of adapalene and benzoyl peroxide gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders: sunburn, blister (including vesicles and bullae), pruritus, hyperpigmentation and hypopigmentation.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available pharmacovigilance data with adapalene and benzoyl peroxide gel use in pregnant women are insufficient to establish a drugassociated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with the combination gel. Adapalene gel, 0.3% Available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations (see Data) . Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown. Based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine.
Hence, maternal use is not expected to result in fetal exposure of the drug. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the MRHD of 2 grams of adapalene and benzoyl peroxide gel based on a mg/m 2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (41 and 81 times the MRHD, respectively, based on a mg/m 2 comparison).
Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).
8.2Lactation Risk Summary Adapalene gel, 0.3% There are no data on the presence of adapalene topical gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, adapalene is present in rat milk with oral administration of the drug. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk (see Clinical Considerations). Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown. Based on the published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine.
Any amount of benzoyl peroxide excreted into human milk by a nursing mother would be expected to be rapidly metabolized by tissue and stomach esterases. There are no data on the presence of benzoyl peroxide in human milk, its effects on the breastfed infant or its effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adapalene and benzoyl peroxide gel and any potential adverse effects on the breastfed child from adapalene and benzoyl peroxide gel or from the underlying maternal condition.
Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use adapalene and… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available pharmacovigilance data with adapalene and benzoyl peroxide gel use in pregnant women are insufficient to establish a drugassociated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with the combination gel. Adapalene gel, 0.3% Available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations (see Data) . Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown. Based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine.
Hence, maternal use is not expected to result in fetal exposure of the drug. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the MRHD of 2 grams of adapalene and benzoyl peroxide gel based on a mg/m 2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (41 and 81 times the MRHD, respectively, based on a mg/m 2 comparison).
Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of adapalene and benzoyl peroxide gel in pediatric patients under the age of 12 have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of adapalene and benzoyl peroxide gel did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Adapalene Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.
Benzoyl peroxide Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.
12.2Pharmacodynamics Pharmacodynamics of adapalene and benzoyl peroxide gel is unknown.
12.3Pharmacokinetics A pharmacokinetic trial was conducted in 26 adult and adolescent subjects (12 to 33 years of age) with severe acne vulgaris who were treated with once-daily applications during a 4-week period with, on average, 2.3 grams/day (range 1.6 to 3.1 grams/day) of adapalene and benzoyl peroxide gel applied as a thin layer to the face, shoulders, upper chest and upper back. After a 4-week treatment, 16 subjects (62%) had quantifiable adapalene plasma concentrations above the limit of quantification of 0.1 ng/mL, with a mean C max of 0.16 ± 0.08 ng/mL and a mean AUC 0-24hr of 2.49 ± 1.21 ng.h/mL.
The most exposed subject had adapalene C max and AUC 0-24hr of 0.35 ng/mL and 6.41 ng.h/mL, respectively. Excretion of adapalene appears to be primarily by the biliary route. Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.
Drug Interactions No formal drug-drug interaction studies were conducted with adapalene and benzoyl peroxide gel.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Adapalene Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.
Benzoyl peroxide Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Adapalene and benzoyl peroxide gel USP, 0.3% / 2.5% is homogeneous, white to very pale yellow opaque gel, and is supplied as follows: 45 gram pump NDC 59651-604-46 60 gram pump NDC 59651-604-60
16.2Storage and handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep away from heat. Protect from light. Keep out of reach of children.
📋 Description ▾
11 DESCRIPTION Adapalene and benzoyl peroxide gel USP, 0.3%/2.5% is a homogeneous, white to very pale yellow, opaque gel for topical use containing adapalene USP 0.3% and benzoyl peroxide USP 2.5%. Adapalene USP, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid).
It has the following structural formula: Adapalene: Molecular formula: C 28 H 28 O 3 Molecular weight: 412.5 Benzoyl peroxide USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula: Benzoyl Peroxide: Molecular formula: C 14 H 10 O 4 Molecular weight: 242.23 Adapalene and benzoyl peroxide gel USP contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan oleate. srt1 str2
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA approved patient labeling (Patient Information). Hypersensitivity Inform patients that serious hypersensitivity reactions occurred with the use of benzoyl peroxide products. If a patient experiences a serious hypersensitivity reaction, instruct patient to discontinue adapalene and benzoyl peroxide gel immediately and seek medical help [see Warnings and Precautions (5.1) ] .
Photosensitivity Advise patients to minimize or avoid exposure to natural or artificial light, including tanning beds or UVA/B treatment. Recommend the use of broad spectrum sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided [see Warnings and Precautions (5.2) ] . Skin Irritation/Contact Dermatitis Inform patients that adapalene and benzoyl peroxide gel may cause irritation such as erythema, scaling, dryness, stinging or burning [see Warnings and Precautions (5.3) ] .
Lactation Use adapalene and benzoyl peroxide gel on the smallest part of the skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply adapalene and benzoyl peroxide gel directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2) ] . Administration Instructions Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry.
Apply adapalene and benzoyl peroxide gel as a thin layer, avoiding the eyes, lips and mucous membranes. Advise patients not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation. Wash hands after application as adapalene and benzoyl peroxide gel may bleach hair and colored fabric.
Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: April 2026
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics A pharmacokinetic trial was conducted in 26 adult and adolescent subjects (12 to 33 years of age) with severe acne vulgaris who were treated with once-daily applications during a 4-week period with, on average, 2.3 grams/day (range 1.6 to 3.1 grams/day) of adapalene and benzoyl peroxide gel applied as a thin layer to the face, shoulders, upper chest and upper back. After a 4-week treatment, 16 subjects (62%) had quantifiable adapalene plasma concentrations above the limit of quantification of 0.1 ng/mL, with a mean C max of 0.16 ± 0.08 ng/mL and a mean AUC 0-24hr of 2.49 ± 1.21 ng.h/mL.
The most exposed subject had adapalene C max and AUC 0-24hr of 0.35 ng/mL and 6.41 ng.h/mL, respectively. Excretion of adapalene appears to be primarily by the biliary route. Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.
Drug Interactions No formal drug-drug interaction studies were conducted with adapalene and benzoyl peroxide gel.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Pharmacodynamics of adapalene and benzoyl peroxide gel is unknown.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The safety and efficacy of adapalene and benzoyl peroxide gel applied once daily for 12 weeks for the treatment of acne vulgaris were assessed in a multicenter, randomized, double-blind, vehicle-controlled trial, comparing adapalene and benzoyl peroxide gel to vehicle gel in subjects with acne vulgaris. The trial also evaluated adapalene and benzoyl peroxide gel, 0.1%/2.5%, a lower strength product than adapalene and benzoyl peroxide gel, 0.3%/2.5%. In this trial, 217 subjects were treated with adapalene and benzoyl peroxide gel, 217 subjects with adapalene and benzoyl peroxide, gel, 0.1%/2.5% and 69 subjects with the vehicle gel.
Treatment response was defined as the percent of subjects who were rated “clear” or “almost clear’ at Week 12 with at least a two-grade improvement based on the Investigator’s Global Assessment (IGA), and mean absolute change from baseline at Week 12 in both inflammatory and non-inflammatory lesion counts. An IGA score of ‘Clear’ corresponded to clear skin with no inflammatory or non-inflammatory lesions. An IGA score of “almost clear” corresponded to a few scattered comedones and a few small papules.
At baseline, 50% of subjects were graded as “moderate” (IGA Grade 3) and 50% were graded as “severe” (IGA Grade 4) on the IGA scale. Subjects had an average of 98 (range 51 to 226) total lesions of which the mean number of inflammatory lesions was 38 (range: 20 to 99) and the mean number of non-inflammatory lesions was 60 (range 30 to 149). Subjects ranged in age from 12 to 57 years, with 273 (54%) of subjects 12 to 17 years of age.
Approximately equal number of males (48%) and females (52%) were enrolled. The IGA success rate, mean reduction, and percent reduction in acne lesion counts from baseline after 12 weeks of treatment are presented in the following table. Table 3.
Clinical Efficacy of Adapalene and Benzoyl Peroxide Gel at Week 12 in Subjects with Acne Vulgaris Adapalene and Benzoyl Peroxide Gel (N=217) Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=217)* Vehicle (N=69) IGA: two-grade improvement and “clear” or “almost clear” 33.7% 27.3% 11.0% Inflammatory lesions: mean absolute (percent) reduction 27.8 (68.7%) 26.5 (69.3%) 13.2 (39.2%) Non-inflammatory lesions: mean absolute (percent) reduction 40.5 (68.3%) 40.0 (68.0%) 19.7 (37.4%) * This trial was not designed or powered to compare the efficacy of adapalene and benzoyl peroxide gel to the lower strength adapalene and benzoyl peroxide gel, 0.1%/2.5%, nor to compare the lower strength adapalene and benzoyl peroxide gel, 0.1%/2.5% to the vehicle control.
In subjects graded as “severe” (IGA Grade 4), efficacy was observed in the adapalene and benzoyl peroxide gel group.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, genotoxicity, or fertility studies were conducted with adapalene and benzoyl peroxide gel. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m 2 /day). The highest dose levels are 3.2 (mice) and 2.4 (rats) times the MRHD of adapalene and benzoyl peroxide gel based on a mg/m 2 comparison.
In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed. No significant increase in tumor formation was observed in rodents topically treated with 15 to 25% benzoyl peroxide carbopol gel (6 to 10 times the concentration of benzoyl peroxide in adapalene and benzoyl peroxide gel) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg/kg benzoyl peroxide (27 to 40 times the MRHD based on a mg/m 2 comparison).
Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 year study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years. Benzoyl peroxide is a tumor promoter in several animal species. The significance of this finding in humans is unknown.
Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). Benzoyl peroxide caused DNA strand breaks and DNA-protein cross-links in mammalian cells, increased sister chromatid exchanges in Chinese hamster ovary cells, and was mutagenic in a few, but not all, in vitro bacterial mutagenicity assays (Ames tests) conducted. In rat oral studies, 20 mg/kg/day adapalene (32 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.
No fertility studies were conducted with benzoyl peroxide.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, genotoxicity, or fertility studies were conducted with adapalene and benzoyl peroxide gel. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m 2 /day). The highest dose levels are 3.2 (mice) and 2.4 (rats) times the MRHD of adapalene and benzoyl peroxide gel based on a mg/m 2 comparison.
In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed. No significant increase in tumor formation was observed in rodents topically treated with 15 to 25% benzoyl peroxide carbopol gel (6 to 10 times the concentration of benzoyl peroxide in adapalene and benzoyl peroxide gel) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg/kg benzoyl peroxide (27 to 40 times the MRHD based on a mg/m 2 comparison).
Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 year study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years. Benzoyl peroxide is a tumor promoter in several animal species. The significance of this finding in humans is unknown.
Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). Benzoyl peroxide caused DNA strand breaks and DNA-protein cross-links in mammalian cells, increased sister chromatid exchanges in Chinese hamster ovary cells, and was mutagenic in a few, but not all, in vitro bacterial mutagenicity assays (Ames tests) conducted. In rat oral studies, 20 mg/kg/day adapalene (32 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.
No fertility studies were conducted with benzoyl peroxide.
📄 Patient Package Insert ▾
Patient information Adapalene and Benzoyl Peroxide (a dap' a leen and ben' zoe il per ox' ide) Gel, USP Important information: Adapalene and benzoyl peroxide gel is for use on the skin only (topical). Do not use adapalene and benzoyl peroxide gel in or on your mouth, eyes, or vagina. What is adapalene and benzoyl peroxide gel?
Adapalene and benzoyl peroxide gel is a prescription medicine used on the skin (topical) to treat acne vulgaris. It is not known if adapalene and benzoyl peroxide gel is safe and effective in children under 12 years of age. Do not use adapalene and benzoyl peroxide gel if you have had an allergic reaction to benzoyl peroxide or any of the ingredients in adapalene and benzoyl peroxide gel.
See the end of this Patient Information leaflet for a complete list of ingredients in adapalene and benzoyl peroxide gel. Before using adapalene and benzoyl peroxide gel, tell your doctor about all of your medical conditions, including if you: have other skin problems, including cuts, abrasions, sunburn or eczema. are pregnant or plan to become pregnant. It is not known if adapalene and benzoyl peroxide gel can harm your unborn baby. are breastfeeding or plan to breastfeed.
It is not known if adapalene and benzoyl peroxide passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use adapalene and benzoyl peroxide gel. If you use adapalene and benzoyl peroxide gel while breastfeeding, use adapalene and benzoyl peroxide gel on the smallest area of the skin and for the shortest time needed.
Do not apply adapalene and benzoyl peroxide gel directly to the nipple and the areola to minimize contact with your baby. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use adapalene and benzoyl peroxide gel?
Use adapalene and benzoyl peroxide gel exactly as your doctor tells you to use it. Apply adapalene and benzoyl peroxide gel 1 time a day. Do not use more adapalene and benzoyl peroxide gel than you need to cover the treatment area.
Using too much adapalene and benzoyl peroxide gel or using it more than 1 time a day may increase your chance of skin irritation. Applying adapalene and benzoyl peroxide gel: Wash the area where the gel will be applied with a mild or soapless cleanser and pat dry. Adapalene and benzoyl peroxide gel comes in a pump.
Depress the pump to dispense a small amount (about the size of a pea) of adapalene and benzoyl peroxide gel and spread a thin layer over the treatment area. Use a pea-sized amount for each area of the face (forehead, chin, and each cheek). Wash your hands right away after applying the gel.
Adapalene and benzoyl peroxide gel may bleach your hair or colored fabrics. Allow adapalene and benzoyl peroxide gel to dry completely before dressing to prevent bleaching of your clothes. What should I avoid while using adapalene and benzoyl peroxide gel?
Avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. Adapalene and benzoyl peroxide gel can make your skin sensitive to sun and the light from tanning beds and sunlamps. Use sunscreen and wear a hat and clothes that cover the areas treated with adapalene and benzoyl peroxide gel if you have to be in sunlight.
Cold weather and wind may irritate skin treated with adapalene and benzoyl peroxide gel. Avoid applying adapalene and benzoyl peroxide gel to cuts, abrasions, and sunburned skin. Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes.
Avoid the use of “waxing” as a hair removal method on skin treated with adapalene and benzoyl peroxide gel. What are the possible side effects of adapalene and benzoyl peroxide gel? Adapalene and benzoyl peroxide gel may cause serious side effects including: Allergic reac… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Pump Label NDC 59651-604-46 Rx only Adapalene and Benzoyl Peroxide Gel, USP 0.3% / 2.5% PUMP FOR TOPICAL USE ONLY AUROBINDO NET WT. 45 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Label
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Pump Carton Label NDC 59651-604-46 Rx only Adapalene and Benzoyl Peroxide Gel, USP 0.3% / 2.5% PUMP FOR TOPICAL USE ONLY NET WT. 45 g AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Carton Label
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |