Quick answers
- What is Adapalene used for?
- The FDA-approved label (Differin, Galderma Laboratories, L.P., December 27, 2023) says: “DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. DIFFERIN Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Adapalene have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Adapalene?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Adapalene been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Adapalene?
- 11 companies list prescription products of Adapalene in the FDA NDC Directory, including Bryant Ranch Prepack, CALL INC. (dba Rochester Pharmaceuticals) and E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC.
What Adapalene is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. DIFFERIN Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
— FDA label: Differin, Galderma Laboratories, L.P., effective December 27, 2023. Read the full label on DailyMed →
The FDA has 13 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Gel · Cream · Swab |
|---|---|
| Route | Topical |
| Prescription products | 13 in the FDA NDC Directory |
| Brand names | Differin |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| adapalene 0.1% cream | Generic | $2.72 per gram |
| adapalene 0.3% gel | Generic | $0.4993–$0.9271 per gram 8 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack3 products
- CALL INC. (dba Rochester Pharmaceuticals)1 product
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC1 product
- Alembic Pharmaceuticals Limited1 product
- Alembic Pharmaceuticals Inc.1 product
- Galderma Laboratories, L.P.1 product
- Encube Ethicals, Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Actavis Pharma, Inc.1 product
- Mayne Pharma Commercial LLC1 product
- Padagis Israel Pharmaceuticals Ltd1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020748 DIFFERIN | Galderma Labs LP | May 26, 2000 | 3, latest August 1, 2014 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2001: Manufacturing (CMC) |
| NDA021753 DIFFERIN | Galderma Labs LP | June 19, 2007 | 6, latest December 27, 2023 2023: Labeling · 2023: Labeling · 2022: Labeling |
Generic approvals (6)
- ANDA090824Fougera Pharms · June 30, 2010
- ANDA200298Encube Ethicals · June 14, 2012
- ANDA201000Actavis Mid Atlantic · October 27, 2014
- ANDA204593Waylis Therap · January 5, 2016
- ANDA208322Sun Pharma Canada · June 23, 2016
- ANDA213508Alembic · June 18, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 313852, 722111, 722113, 798061 |
|---|---|
| SPL set ID of the quoted label | a0031324-92a6-4c11-90e2-c2818f7278ec |
| FDA labels (SPL) | 13 |
| FDA applications | NDA020748, NDA021753, 6 ANDA |
| Active ingredients (FDA) | ADAPALENE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Differin, Galderma Laboratories, L.P., effective December 27, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →