Is Adapalene registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Adapalene, including ADOLIN 0.1% W-W CREAM (0.1 %, Cream, SAR 17.15); ADOLIN 0.1% W-W GEL (0.1 %, Gel, SAR 17.15); DIFFERIN 0.1% CREAM (0.1 %, Cream, SAR 18.75); DIFFERIN 0.1% GEL (0.1 %, Gel, SAR 18.75); SURECURE 0.1% TOPICAL GEL (0.1 %, Gel, SAR 18.05).

Is Adapalene approved by the US FDA?

Drugs@FDA lists 16 application product lines for Adapalene, including DIFFERIN (Over-the-counter); DIFFERIN (Prescription); DIFFERIN (Prescription); ADAPALENE (Over-the-counter); ADAPALENE (Prescription).

Are there safety signals or safety updates for Adapalene?

US FDA: 3 entries (latest 2023-12-27).

Active substance

Adapalene

SFDA 7
US FDA 16
Health Canada 3
US price lines 6
NHS prices 2
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ADOLIN 0.1% W-W CREAM	0.1 %	Cream · Topical	1 Bottle	SAR 17.15	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
ADOLIN 0.1% W-W GEL	0.1 %	Gel · Topical	1 Bottle	SAR 17.15	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
DIFFERIN 0.1% CREAM	0.1 %	Cream · Topical	1 Bottle	SAR 18.75	NCE · Prescription	GALDERMA	Valid
DIFFERIN 0.1% GEL	0.1 %	Gel · Topical	1 Bottle	SAR 18.75	NCE · Prescription	GALDERMA	Valid
SURECURE 0.1% TOPICAL GEL	0.1 %	Gel · Topical	1 Bottle	SAR 18.05	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
WATENE 0.1% CREAM	0.1 %	Cream · Topical	1 Bottle	SAR 21.95	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
WATENE 0.1% GEL	0.1 %	Gel · Topical	1 Bottle	SAR 21.95	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
DIFFERIN	0.1%	gel · topical	GALDERMA LABS LP	Over-the-counter	31 May 1996
DIFFERIN	0.1%	cream · topical	GALDERMA LABS LP	Prescription	26 May 2000
DIFFERIN	0.3%	gel · topical	GALDERMA LABS LP	Prescription	19 Jun 2007
ADAPALENE	0.1%	gel · topical	P AND L	Over-the-counter	2 Jun 2010
ADAPALENE	0.1%	cream · topical	FOUGERA PHARMS	Prescription	30 Jun 2010
ADAPALENE	0.1%	gel · topical	GLENMARK PHARMS	Over-the-counter	1 Jul 2010
ADAPALENE	0.3%	gel · topical	ENCUBE ETHICALS	Prescription	14 Jun 2012
ADAPALENE	0.3%	gel · topical	ACTAVIS MID ATLANTIC	Prescription	27 Oct 2014
ADAPALENE	0.1%	solution · topical	WAYLIS THERAP	Prescription	5 Jan 2016
ADAPALENE	0.3%	gel · topical	SUN PHARMA CANADA	Prescription	23 Jun 2016
ADAPALENE	0.1%	solution · topical	WAYLIS THERAP	Prescription	23 Sep 2016
ADAPALENE	0.3%	gel · topical	ALEMBIC	Prescription	18 Jun 2020
ADAPALENE	0.1%	gel · topical	SUN PHARMA CANADA	Over-the-counter	14 Jan 2022
ADAPALENE	0.1%	gel · topical	UNIQUE	Over-the-counter	30 Jun 2026
DIFFERIN	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · topical	GALDERMA LABS LP	Discontinued	31 May 1996
DIFFERIN	0.1%	lotion · topical	GALDERMA LABS LP	Discontinued	17 Mar 2010

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DIFFERIN	02148749	0.1 %	GEL · TOPICAL	GALDERMA CANADA INC.
DIFFERIN	02231592	0.1 %	CREAM · TOPICAL	GALDERMA CANADA INC.
DIFFERIN XP	02274000	0.3 %	GEL · TOPICAL	GALDERMA CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ADAPALENE 0.1% CREAM	$2.85454	per GM	23 Sep 2026
US NADAC	ADAPALENE 0.1% GEL	$0.4655	per GM	23 Sep 2026
US NADAC	ADAPALENE 0.1% GEL	$0.33648	per GM	23 Sep 2026
US NADAC	ADAPALENE 0.3% GEL	$0.50376	per GM	23 Sep 2026
US NADAC	ADAPALENE 0.3% GEL PUMP	$0.85025	per GM	23 Sep 2026
US NADAC	GNP ADAPALENE 0.1% GEL	$0.4655	per GM	23 Sep 2026
NHS Drug Tariff	Adapalene 0.1% cream	£18.26	50 gram	1 Oct 2026
NHS Drug Tariff	Adapalene 0.1% gel	£18.26	50 gram	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 27 Dec 2023 DIFFERIN — safety-related labeling change
Labeling sections changed: Contraindications; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Apr 2023 DIFFERIN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Apr 2022 EPIDUO FORTE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for adapalene →

Combinations containing Adapalene

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.