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Adapalene Paraben Free

Adapalene · Gel

Over-the-counter ANDA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Adapalene Paraben Free
Generic name
Adapalene
Dosage form
Gel
Route
Topical
Marketing category
ANDA · ANDA
Labeler
CVS PHARMACY, INC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
5
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Adapalene 1 mg/g 829539 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Gel
Route of administration
Topical
Presentations
9

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Retinoid [EPC] EPC All 35 members
Retinoids [CS] CS All 35 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
090962
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 2, 2010
Sponsor
P AND L
Products on application
1
Submissions recorded
3
Products approved under application 090962.
Product Trade name Form Strength Ingredient Status TE Flags
090962-001 ADAPALENE GEL ADAPALENE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 090962.
Type No. Action Status Date Review
Supplement 8 Manufacturing (CMC) Approved March 10, 2026 Unknown
Supplement 5 Manufacturing (CMC) Approved July 8, 2019 Unknown
Original application 1 Approved June 2, 2010 —

Review documents

  • 0 · Original application · June 8, 2010

Adverse event reports

Source: openFDA FAERS
181,513
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ADAPALENE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
51316-219-05 51316-219 CVS PHARMACY, INC 1 TUBE in 1 CARTON (51316-219-05) / 15 g in 1 TUBE September 15, 2026
51316-219-16 51316-219 CVS PHARMACY, INC 1 TUBE in 1 CARTON (51316-219-16) / 45 g in 1 TUBE September 15, 2026
79481-2210-5 79481-2210 Meijer Distribution Inc. 1 TUBE in 1 CARTON (79481-2210-5) / 15 g in 1 TUBE September 15, 2026
30142-542-05 30142-542 The Kroger Co. 1 TUBE in 1 CARTON (30142-542-05) / 15 g in 1 TUBE September 15, 2026
76162-221-05 76162-221 Topco Associates 1 TUBE in 1 CARTON (76162-221-05) / 15 g in 1 TUBE September 15, 2026
51316-219 51316-219 CVS PHARMACY, INC — September 15, 2026
79481-2210 79481-2210 Meijer Distribution Inc. — September 15, 2026
30142-542 30142-542 The Kroger Co. — September 15, 2026
76162-221 76162-221 Topco Associates — September 15, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.