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Effaclar

Adapalene · Gel

Over-the-counter ANDA Official labelling
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
Effaclar
Generic name
Adapalene
Dosage form
Gel
Route
Topical
Marketing category
ANDA · ANDA
Labeler
LOreal USA Products Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
4
Data completeness
76% 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
6

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
091314
Application type
ANDA · Abbreviated New Drug Application
Approval date
July 1, 2010
Sponsor
GLENMARK PHARMS
Products on application
2
Submissions recorded
2
Products approved under application 091314.
Product Trade name Form Strength Ingredient Status TE Flags
091314-001 ADAPALENE GEL ADAPALENE Over-the-counter —
091314-002 ADAPALENE GEL ADAPALENE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 091314.
Type No. Action Status Date Review
Supplement 5 Labeling Approved July 9, 2019 Standard
Original application 1 Approved July 1, 2010 —

Review documents

  • 0 · Original application · January 7, 2021

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251223). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251223 HUMAN OTC DRUG · 20190823

Indications and Usage

openFDA Drug Labeling

Use • for the treatment of acne

Purpose Acne treatment

Dosage and Administration

openFDA Drug Labeling

Directions Adults and children 12 years of age and older: • use once daily • clean the skin gently and pat dry before applying the product • cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face. • do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation. Children under 12 years of age : ask a doctor

Warnings For external use only Do not use • on damaged skin (cuts, abrasions, eczema, sunburn) • if you are allergic to adapalene or any of the ingredients in this product. If pregnant or breast-feeding , ask a doctor before use. When using this product • limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors • do not wax to remove hair in areas where the product has been applied • during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe • irritation (redness, itching, dryness, burning) is more likely to occur: • in the first few weeks of use • if using more than one topical acne medication at a time • but irritation usually lessens with continued use of this product • it may take up to 3 months of once daily use to see results • avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water. • wash hands after use Stop use and ask doctor if • you become pregnant, or are planning to become pregnant, while using the product • you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) • irritation becomes severe • you see no improvement after 3 months of once daily use

Active Ingredient

openFDA Drug Labeling

Active ingredient Adapalene USP, 0.1% (retinoid)* *read consumer information leaflet

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
49967-591-01 49967-591 LOreal USA Products Inc 1 TUBE in 1 CARTON (49967-591-01) / 45 g in 1 TUBE August 23, 2019
49967-591-02 49967-591 LOreal USA Products Inc 1 TUBE in 1 CARTON (49967-591-02) / 3 g in 1 TUBE October 22, 2019
49967-592-01 49967-592 LOreal USA Products Inc 1 TUBE in 1 CARTON (49967-592-01) / 45 g in 1 TUBE September 16, 2024
49967-592-02 49967-592 LOreal USA Products Inc 1 TUBE in 1 CARTON (49967-592-02) / 3 g in 1 TUBE September 16, 2024
49967-591 49967-591 LOreal USA Products Inc — August 23, 2019
49967-592 49967-592 LOreal USA Products Inc — September 16, 2024

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
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.