FDA-filed SPL labeling · retrieved through openFDA

Adapalene

Adapalene is a topical retinoid used to treat acne across multiple products and formulations, including Differin, Curist Acne Relief, Effaclar, and Neutrogena Adapalene 0.1% Acne Treatment.

Brand names DifferinEffaclarPanOxylProactiv MD AdapaleneCurist Acne Relief +2 more
Drug class Retinoid
Rx/OTC Forms 2 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 51 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveNov 28, 2022
Clinical labels in scope 51
AvailabilityRx/OTC
Earliest approval/marketing year 1996
FDA-listed product records 123
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 21, 2026
Adapalene at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Adapalene is a proven topical retinoid for treating acne, available in several brands and formulations for use in patients 12 and older. It works best applied once daily in the evening to clean, dry skin — expect some initial dryness or irritation that usually fades over time. Always use sunscreen during treatment, and contact your doctor if you have a severe reaction.

📖 Adapalene: Patient Information Guide

A plain-language walkthrough of Adapalene — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Adapalene is a topical retinoid approved for the treatment of acne vulgaris (acne) across multiple products and formulations.

  • Differin Gel (0.1% and 0.3%) is indicated for the topical treatment of acne vulgaris in patients 12 years and older
  • Adapalene Gel 0.1% is indicated for treating acne vulgaris
  • Adapalene Gel 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years and older
  • Adapalene Cream 0.1% is indicated for the topical treatment of acne vulgaris
  • Adapalene Topical Solution 0.1% is indicated for the topical treatment of acne vulgaris
  • Curist Acne Relief, Effaclar, Neutrogena Adapalene 0.1% Acne Treatment, and other listed gel products are each indicated for the treatment of acne
⚙️How it works

Adapalene belongs to a class of medications called retinoids. It binds to specific retinoic acid nuclear receptors (proteins inside skin cell nuclei) but does not bind to a different receptor type called the cytosolic receptor. By acting on these nuclear receptors, adapalene helps regulate how follicular epithelial cells — the cells lining your pores — grow and mature. This reduces the formation of microcomedones (tiny blocked pores that are the starting point of most acne) and also modulates the inflammatory processes that make acne worse.

💊How it's taken

All adapalene products are applied to the skin once daily, generally in the evening. Gently wash and dry the affected area first, then apply a thin layer to the entire affected area — not just individual blemishes. Avoid the eyes, lips, and mucous membranes.

  • Differin Gel and Adapalene Gel 0.1%: apply a thin film to the face and any other affected areas once daily in the evening after washing with a non-medicated soap
  • Adapalene Topical Solution: apply once daily in the evening to clean, dry skin; if using the single-use swab form, discard the swab after one use
  • For any form: applying more than once a day will not improve results faster and may worsen irritation
  • If you see no improvement after 8–12 weeks, check back with your prescriber
🤒Side effects — in detail

The most common side effects with adapalene are skin reactions at the application site, especially in the first few weeks of treatment.

  • Dryness
  • Redness (erythema)
  • Scaling or flaking
  • Burning or stinging
  • Skin peeling (desquamation)
  • Temporary acne flare in early weeks of use
  • Skin discomfort

These effects are usually mild to moderate and tend to improve as treatment continues. Serious reactions are rare but include swelling of the face, eyelids, or lips, and severe allergic reactions — stop use and get medical help right away if those occur.

⚠️Warnings & precautions
  • Allergic reactions: Rare but serious reactions including anaphylaxis (severe whole-body allergic response), face swelling, and lip swelling have been reported. Stop using adapalene and seek medical attention immediately if these occur.
  • Sun sensitivity: Adapalene can make skin more sensitive to sunlight. Minimize sun exposure, avoid sunlamps, and use sunscreen and protective clothing when outdoors. People with naturally high sun sensitivity should be especially careful.
  • Skin irritation: Redness, dryness, peeling, and stinging are most likely in the first four weeks. Avoid applying to cuts, sunburned, or eczema-affected skin. Extreme weather (wind, cold) can also worsen irritation.
  • Waxing: Avoid waxing skin treated with adapalene, as it can cause injury to irritated skin.
  • Other irritating products: Be cautious when combining adapalene with medicated soaps, astringents, strong alcohol-based products, or preparations containing sulfur, resorcinol, or salicylic acid — these can increase skin irritation.
🔀What it interacts with

Adapalene itself has few systemic drug interactions, but it can interact with other topical products by increasing skin irritation.

  • Medicated or abrasive soaps and cleansers — can worsen skin irritation when used alongside adapalene
  • Products with high alcohol content, strong astringents, or cosmetics with a strong drying effect — increase risk of irritation
  • Preparations containing sulfur, resorcinol, or salicylic acid — use particular caution; let these products clear from the skin before starting adapalene topical solution
  • Spice- or lime-based skincare products — can aggravate local skin reactions

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use adapalene if you are allergic to adapalene or any ingredient in the product
  • Not established as safe or effective in children under 12 years of age — ask a doctor first
  • Safety and effectiveness in adults 65 and older have not been established
  • If you are pregnant or planning to become pregnant: animal studies at high oral doses showed fetal harm; discuss the risks and benefits with your doctor before using
  • If you are breastfeeding: it is unknown whether topical adapalene passes into breast milk in meaningful amounts; use on the smallest area for the shortest time possible, and avoid applying near areas where your infant could be exposed
  • If you currently have sunburn, wait until your skin has fully healed before starting adapalene
  • Tell your doctor about all other topical products you use on the same areas of skin
🚑If you take too much

Adapalene is for skin use only — if applied too much, it will not work faster or better, and it may cause marked redness, peeling, or discomfort. If adapalene is accidentally swallowed, chronic ingestion may produce effects similar to excessive oral intake of Vitamin A. Contact a poison control center or seek medical care if accidental ingestion occurs.

📡Pharmacodynamics — effects in the body

Adapalene acts as a modulator of cellular differentiation (how skin cells mature), keratinization (how skin cells form and shed), and inflammatory processes — all of which play important roles in acne development. By normalizing how the cells lining hair follicles grow and turn over, it helps prevent the formation of microcomedones, the early blocked pores that develop into acne lesions. The FDA label notes that formal clinical pharmacodynamic studies have not been conducted for the 0.3% gel formulation specifically.

🔬Pharmacokinetics — how your body processes it

Very little adapalene is absorbed into the bloodstream when applied to the skin. In a clinical study using Adapalene Gel 0.3% applied to the face, chest, and back once daily, blood levels were measurable but very low, with a mean peak concentration well under 1 ng/mL. The time the drug stays in the body (half-life) ranged from 7 to 51 hours, and adapalene was largely cleared from the blood within 72 hours of the last application. When used at typical daily amounts on the face only, blood levels were generally undetectable. Adapalene is excreted primarily through bile (the biliary route).

📦How to store it

Store at controlled room temperature 68° to 77°F (20° to 25°C). Protect from freezing.

📄 Written from Adapalene’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Adapalene — the kind of thing our pharmacy team would talk through with you at the counter.

How long does it take for adapalene to clear up my acne?
Most people start to see meaningful improvement after 8 to 12 weeks of consistent use. In the early weeks, your acne might actually look a little worse before it gets better — this is normal and happens because the medication is bringing underlying clogged pores to the surface. Stick with it unless you develop severe irritation, and check in with your doctor or pharmacist at the 12-week mark if you're not seeing results.
My skin is really red and dry after starting adapalene — is that normal?
Yes, redness, dryness, flaking, and mild stinging are the most common side effects, especially in the first few weeks. They're usually mild to moderate and tend to get better as your skin adjusts. Try using a gentle, non-medicated moisturizer to ease discomfort, and make sure you're only applying adapalene once daily — using more won't help faster and can make irritation worse. If your skin is severely irritated, it's okay to talk to your pharmacist or doctor about applying it every other day until your skin adapts.
Can I use my regular face wash or toner along with adapalene?
You can use a gentle, non-medicated cleanser, but be careful with anything harsh or drying. Strong astringents, alcohol-heavy toners, abrasive scrubs, or products with salicylic acid, sulfur, or resorcinol can really amp up the irritation when combined with adapalene. If you use any of those, talk to your pharmacist before starting — you may need to let your skin clear from those products first.
Do I need to wear sunscreen while using adapalene?
Yes — this is an important one. Adapalene can make your skin more sensitive to sunlight. The label specifically recommends minimizing sun exposure, avoiding sunlamps, and using sunscreen and protective clothing whenever you go outside. This is especially important if you already have sensitive or sun-prone skin.
Is adapalene safe to use if I'm pregnant or breastfeeding?
This is a conversation to have with your doctor before continuing or starting adapalene. Animal studies at high oral doses showed fetal harm, and the available human data in pregnancy isn't enough to rule out risk. If you're breastfeeding, it's not known whether enough adapalene passes into breast milk to affect a baby — so the guidance is to use it on the smallest area of skin for the shortest time needed, and keep it away from areas where your baby could come into contact with it.
Can my 10-year-old use adapalene for acne?
The FDA label says adapalene's safety and effectiveness have not been established in children under 12 years of age. For kids under 12, you should ask a doctor before using any adapalene product. For teens 12 and older, adapalene is approved and appropriate — just follow the product directions and start with once-daily use as directed.
Is Adapalene available over the counter?
Both — Adapalene is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Adapalene first available?
Adapalene has been available in the United States since at least 1996, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Adapalene?
Adapalene is supplied by 65 manufacturers listed in the FDA NDC Directory, including Walgreens, Galderma Laboratories, L.P., Yyba Corp.

💬 Answers drafted from Adapalene’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Adapalene comes

Adapalene is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

On the skin
Brands Curist Acne Relief Differin Effaclar Neutrogena Adapalene 0.1% Acne Treatment PanOxyl Proactiv MD Adapalene
How this form is used
What it may be used for
  • Differin Gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older
  • Adapalene Gel 0.1% is a topical retinoid used for treating acne vulgaris
  • Curist Acne Relief, Effaclar, and Neutrogena Adapalene 0.1% Acne Treatment are each indicated for the treatment of acne
  • Adapalene Cream 0.1% is indicated for the topical treatment of acne vulgaris
Important instructions
  • Differin Gel: wash affected areas gently with a non-medicated soap, then apply a thin film to the entire face and other affected areas once daily in the evening; avoid the eyes, lips, and mucous membranes
  • Neutrogena Adapalene 0.1%, Curist Acne Relief, and Effaclar: clean skin gently and pat dry, then cover the entire affected area with a thin layer once daily; do not apply more than once a day
  • Adapalene Gel 0.1%: apply a thin film to the entire face and any other affected areas once daily in the evening after washing gently with a non-medicated soap
  • For adults and children 12 and older; children under 12 should ask a doctor before use
Available strengths 6 strengths
108 FDA-listed product records

Topical solution

On the skin
How this form is used
What it may be used for
  • Adapalene Topical Solution 0.1% is indicated for the topical treatment of acne vulgaris
Important instructions
  • Adapalene Topical Solution: apply once daily to affected areas; before retiring in the evening, wash and dry areas to be treated, then apply a thin film
  • Adapalene Topical Solution (swab form): remove swab from foil just before use, apply to affected areas, and discard swab after single use — do not reuse
  • Avoid the eyes, lips, and mucous membranes; replace cap after each use for the bottle form
  • Adapalene Topical Solution: an apparent worsening of acne may occur in early weeks — this is normal and not a reason to stop; results are typically noticed after 8 to 12 weeks
Available strengths 1 strength
3 FDA-listed product records

📊 Adapalene across the U.S. market

How Adapalene appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms
65
Manufacturers
11
Brand names
123
FDA-listed product records
1996
First marketed

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Walgreens8%
Galderma Laboratories, L.P.6%
Yyba Corp5%
P & L Development, LLC4%
Taro Pharmaceuticals U.S.A., Inc.4%
Bryant Ranch Prepack4%
Other makers68%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Adapalene is used

A general measure of how commonly Adapalene is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Adapalene is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

126,305
Medicaid prescriptions filled (Q1–Q4 2025)
$9.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Adapalene prescribed? Of the 1,596 medications we measure, Adapalene ranks #474 by Medicaid prescriptions — more than 70% of them.

Where Adapalene ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Adapalene product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mg/mL topical cream is the most-dispensed Adapalene product — about 42% of these Medicaid prescriptions.

adapalene 1 MG/ML Topical Cream Most dispensed

52,877 Medicaid prescriptions (Q1–Q4 2025) 42% of Adapalene prescriptions shown $7M gross reimbursement (before rebates) ≈ $132 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313852

adapalene 0.003 MG/MG Topical Gel

42,208 Medicaid prescriptions (Q1–Q4 2025) 33% of Adapalene prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $40 per prescription (gross)

Summed across the 9 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 722111

adapalene 0.001 MG/MG Topical Gel

31,173 Medicaid prescriptions (Q1–Q4 2025) 25% of Adapalene prescriptions shown $613,173 gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 9 of 70 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 307731

Other Adapalene products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

47 Medicaid prescriptions (Q1–Q4 2025) <1% of Adapalene prescriptions shown $24,220 gross reimbursement (before rebates) ≈ $515 per prescription (gross)

Summed across the 1 of 30 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Adapalene, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 21 of 130 listed Adapalene NDCs with Medicaid activity.

🔍 Compare Adapalene products

A representative set of FDA-listed product records for Adapalene — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 123 of 123 products — FDA National Drug Code Directory. See every product, package size and price: browse all 123 Adapalene NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Adapalene RxCUI 60223 5 dose forms · 6 strengths
  1. Dose form (SCDF) Medicated Pad RxCUI 798060 No current FDA listing
    Clinical drug / strength (SCD) 1 MG/ML RxCUI 798061
  2. Dose form (SCDF) Topical Cream RxCUI 377847 In current FDA listings
    Clinical drug / strength (SCD) 1 MG/ML RxCUI 313852
  3. Dose form (SCDF) Topical Gel RxCUI 377966 In current FDA listings
    Clinical drug / strength (SCD) 0.001 MG/MG RxCUI 307731 0.003 MG/MG RxCUI 722111
  4. Dose form (SCDF) Topical Lotion RxCUI 905384 In current FDA listings
    Clinical drug / strength (SCD) 1 MG/ML RxCUI 905385
  5. Dose form (SCDF) Topical Solution RxCUI 385086 In current FDA listings
    Clinical drug / strength (SCD) 1 MG/ML RxCUI 307732

Look up RxCUI 60223 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Differin Effaclar PanOxyl Proactiv MD Adapalene Curist Acne Relief Neutrogena Adapalene 0.1% Acne Treatment Proactiv MD Adapalene Acne Treatment

🏭 Manufacturers & labelers

Walgreens 8 Galderma Laboratories, L.P. 6 Yyba Corp 5 P & L Development, LLC 4 Taro Pharmaceuticals U.S.A., Inc. 4 Bryant Ranch Prepack 4 Kenvue Brands LLC 3 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 3 TOP CARE (Topco Associates LLC) 3 Crown Laboratories 3 Glenmark Therapeutics Inc., Usa 3 CALL INC. (dba Rochester Pharmaceuticals) 3 LOreal USA Products Inc 3 Alchemee, LLC 3 Cvs Pharmacy, Inc 2 L�Oreal USA Products Inc 2 Little Pharma, Inc. 2 Stryke Club, Inc. 2 Safeway, Inc. 2 Galderma Laboratories, L.p 2 Meijer Distribution Inc. 2 Excella GmbH & Co.KG 2 Meijer, Inc. 2 Actavis Pharma, Inc. 2

…and 16 more on the FDA NDC directory.

RxNorm drug class

Adapalene belongs to the Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Retinoids for topical use in acne

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 28, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Adapalene.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Adapalene after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
51
NDC products indexed
123
Distinct labelers/manufacturers represented
65
Linked representative label
Mayne Pharma Commercial LLC.
Linked label effective
Nov 28, 2022
Composite sections available
24
Linked SPL Set ID
9a0d9a0d-a9f3-4eb9-be76-166ef182d13a
Linked SPL Document ID
86366747-19bc-4279-8e62-afc7c8682e4b
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 2

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 51 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Mayne Pharma Commercial LLC. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.