adapalene and benzoyl peroxide 1 mg/g; 25 mg/g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Peroxides class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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UNII 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
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UNII NMQ347994Z
Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
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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.
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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.
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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.
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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.
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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.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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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.
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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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $0.329 | $14.80 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $0.7216 | $32.47 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $1.13 | $50.85 / 45 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 mg/g; 25 mg/g 21922-0052-50 | Encube | 1 bottle | $0.329 | AB | Availability likely | — |
| adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g 45802-0846-01 | Padagis | 45 g | $0.329 | AB | Availability likely | — |
| ADAPALENE and BENZOYL PEROXIDE 1 mg/g; 25 mg/g 51672-1364-03 | Sun | 1 bottle | $0.329 | AB | Availability likely | — |
| adapalene and benzoyl peroxide 1 mg/g; 25 mg/gthis 68462-0301-47 | Glenmark | 1 bottle | $0.329 | AB | Availability likely | — |
| Differin Epiduo 1 mg/g; 25 mg/g 00299-4908-00 | Galderma | 2 g | — | — | FDA listed | — |
| adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g 63629-8607-01 | Bryant | 1 bottle | — | AB | FDA listed | — |
| adapalene and benzoyl peroxide .1 g/100g; 2.5 g/100g 72162-1430-02 | Bryant | 45 g | — | AB | FDA listed | — |
| Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% 1 mg/g; 25 mg/g 72162-2296-02 | Bryant | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ 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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68462-0301-47 You're viewing this | 1 BOTTLE, PUMP in 1 CARTON (68462-301-47) / 45 g in 1 BOTTLE, PUMP | $0.3288 / g | $14.80 | 2019-11-08 | Active |
| 68462-0301-55 | 45 g in 1 TUBE (68462-301-55) | — | — | 2019-11-08 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 68462-0301-47?
What NDC number is used to bill for this package of adapalene and benzoyl peroxide 1 mg/g; 25 mg/g Gel?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 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 patients 9 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 patients 9 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 film 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).
Avoid the eyes, lips and mucous membranes. Adapalene and benzoyl peroxide gel is not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply a thin film 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). 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 contains 1 mg (0.1%) adapalene, USP and 25 mg (2.5%) benzoyl peroxide, USP in a white to pale yellow, opaque gel. Each gram of adapalene and benzoyl peroxide gel contains 1 mg (0.1%) adapalene, USP and 25 mg (2.5%) benzoyl peroxide, USP. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided. ( 5.1 ) Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of adapalene and benzoyl peroxide gel and may necessitate discontinuation. ( 5.2 )
5.1Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized 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 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.
5.2Local Cutaneous Reactions 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 Most commonly reported adverse events (≥1%) in patients treated with adapalene and benzoyl peroxide gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Studies Experience 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 clinical trials, 1401 subjects were exposed to adapalene and benzoyl peroxide gel. A total of 1036 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months.
Related adverse events reported within 12 weeks of treatment and in at least 1% of subjects treated with adapalene and benzoyl peroxide gel and those reported in subjects treated with the vehicle gel are presented in Table 1: Table 1 Drug Related Adverse Events Reported in Clinical Trials by At Least 1% of Patients Treated For 12 Weeks System Organ Class/Preferred Term Adapalene and Benzoyl Peroxide gel N = 564 Vehicle gel N = 489 Subjects with AE (s) 14% 4% Dry Skin 7% 2% Contact dermatitis 3% <1% Application site burning 2% <1% Application site irritation 1% <1% Skin irritation 1% 0% Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials by assessment of erythema, scaling, dryness, burning, and stinging.
Table 2 Incidence of Local Cutaneous Irritation in Controlled Clinical Trials (N = 553) Treatment Emergent Signs and Symptoms Maximum Severity During Treatment End of Treatment Severity (12 Weeks) Mild Moderate Severe Mild Moderate Severe Erythema 27% 13% 1% 8% 2% 1% Scaling 35% 11% 1% 9% 1% <1% Dryness 41% 13% 1% 10% 2% <1% Stinging/burning 41% 15% 3% 7% 2% 1% Analysis over the 12-week period showed that local tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 of therapy and decreased thereafter.
During a pediatric clinical trial, 285 children with acne vulgaris, 9 to 11 years of age were treated with adapalene and benzoyl peroxide gel or with the vehicle gel once daily for 12 weeks. Overall, the safety profile of adapalene and benzoyl peroxide gel in these subjects is comparable to the safety profile observed in older subjects 12 years of age and above, both in the nature and frequency of the observed events. Analysis of local tolerability evaluations shows similar incidence of treatment emergent signs and symptoms as in subjects 12 years of age and above, with local tolerability signs and symptoms peaking during the first week and decreasing over time.
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of adapalene and benzoyl peroxide gel: eyelid edema, sunburn, blister, pain of skin, pruritus, swelling face, conjunctivitis, skin discoloration, rash, eczema, throat tightness and allergic contact dermatitis. 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.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted with adapalene and benzoyl peroxide gel.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with adapalene and benzoyl peroxide gel. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide.
Furthermore, such studies are not always predictive of human response; therefore, adapalene and benzoyl peroxide gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus. No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5 mg adapalene/kg/day, up to 25 times (mg/m 2 /day) the maximum recommended human dose (MRHD) of 2 grams of adapalene and benzoyl peroxide gel. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively.
Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits. Dermal teratology studies conducted in rats and rabbits at doses of 0.6 to 6 mg adapalene/kg/day [25 to 59 times (mg/m 2 ) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits.
8.3Nursing Mothers It is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of adapalene and benzoyl peroxide gel. Because many drugs are excreted in human milk, caution should be exercised when adapalene and benzoyl peroxide gel is administered to a nursing woman.
8.4Pediatric Use Safety and effectiveness of adapalene and benzoyl peroxide gel in pediatric patients under the age of 9 have not been established.
8.5Geriatric Use Clinical studies of adapalene and benzoyl peroxide gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with adapalene and benzoyl peroxide gel. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide.
Furthermore, such studies are not always predictive of human response; therefore, adapalene and benzoyl peroxide gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus. No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5 mg adapalene/kg/day, up to 25 times (mg/m 2 /day) the maximum recommended human dose (MRHD) of 2 grams of adapalene and benzoyl peroxide gel. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively.
Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits. Dermal teratology studies conducted in rats and rabbits at doses of 0.6 to 6 mg adapalene/kg/day [25 to 59 times (mg/m 2 ) the MRHD] exhibited no fetotoxicity and only minimal increases in 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 9 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 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 study was conducted in 10 adult subjects with acne vulgaris who were treated once daily for 30 days with 2 grams/day of adapalene and benzoyl peroxide gel applied to 1000 cm 2 of acne involved skin, (face, chest, and upper back). Two subjects (20%) had quantifiable adapalene plasma concentrations above the limit of quantification (LOQ = 0.1ng/mL). The highest adapalene C max and AUC 0-24h was 0.21 ng/mL and 1.99 ng•h/mL, respectively.
Excretion of adapalene appears to be primarily by the biliary route. Pharmacokinetics of adapalene and benzoyl peroxide gel in pediatric subjects have not been evaluated. Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid and eliminated in the urine.
🧬 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 Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is white to pale yellow in color and opaque in appearance, and is supplied as follows: 45 gram tube NDC 68462-301-55 45 gram pump NDC 68462-301-47 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]. Protect from light. Keep out of reach of children. Keep away from heat. Keep tube tightly closed.
📋 Description ▾
11 DESCRIPTION Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is a white to pale yellow, opaque gel for topical use containing adapalene, USP, 0.1%, 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, USP is 6-(4-Methoxy-3-(tricyclo [3.3.1.13,7 ]dec-1-ylphenyl)-2-naphthalene carboxylic acid .
It has the following structural formula: Adapalene, USP: Molecular formula: C 28 H 28 O 3 Molecular weight: 412.52 g/mol Benzoyl peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide, USP is dibenzoyl peroxide. It has the following structural formula: Benzoyl Peroxide, USP: Molecular formula: C 14 H 10 O 4 Molecular weight: 242.23 g/mol Adapalene and Benzoyl Peroxide Gel contains the following inactive ingredients: carbomer homopolymer type C, cyclomethicone, docusate sodium, edetate disodium, glycerin, propylene glycol, poloxamer 124, purified water, sorbitan oleate and sodium hydroxide. adapalenestructure benzoylperoxidestructure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION [See FDA approved Patient Labeling (Patient Information)] Information for Patients - 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. - Adapalene and benzoyl peroxide gel may cause irritation such as erythema, scaling, dryness, stinging or burning. - Advise patients to minimize exposure to sunlight, including sunlamps. - Recommend the use of sunscreen products and protective apparel, (e.g., hat) when exposure cannot be avoided. - Adapalene and benzoyl peroxide gel may bleach hair and colored fabric.
Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com May 2025 logo1