Regulatory PathRegulatory requirements compared

Active substance

Tretinoin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ACNELIN0.05 %Cream · Topical1 TubeSAR 15.80Generic · PrescriptionHAYAT PHARMACEUTICAL INDUSTRIESValid
ACRETIN0.05 %Cream · Topical1 TubeSAR 19.50Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
ACRETIN0.025 %Cream · Topical1 TubeSAR 18.85Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
AVOTIN- A0.05 %Cream · Topical1 BottleSAR 17.40Generic · PrescriptionMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
Tretinoin Dawaa Health0.05 % (W/W)Cream · Topical1 TubeSAR 17.40Generic · PrescriptionAl Dawaa Medical Services Co LtdValid
ACNE TOP 0.05% W-W CREAM0.05 %Cream · Topical1 TubeSAR 14.30Generic · PrescriptionDEEF PHARMACEUTICAL INDUSTRIESWithdrawn by MAH · Not Marketed
EUDYNA CREAM 0.05%0.05 %Cream · Topical1 TubeSAR 13.65NCE · PrescriptionKnoll PharmaceuticalsInvalid · Not Marketed
EUDYNA GEL 0.05%0.05 %Gel · Topical1 TubeSAR 13.40NCE · PrescriptionKnoll PharmaceuticalsInvalid · Not Marketed
OPTIMAL 0.025% GEL0.025 %Gel · Topical30 TubeSAR 7.00Generic · PrescriptionPharma International Co.Withdrawn by MAH · Not Marketed
OPTIMAL 0.05% CREAM0.05 %Cream · Topical30 TubeSAR 11.65Generic · PrescriptionPharma International Co.Withdrawn by MAH · Not Marketed
RETACNYL 0.025% CREAM0.025 %Cream · Topical1 BottleSAR 15.35Generic · PrescriptionGALDERMAWithdrawn by MAH · Not Marketed
RETACNYL 0.05% CREAM0.05 %Cream · Topical1 BottleSAR 17.80Generic · PrescriptionGALDERMAWithdrawn by MAH · Not Marketed
RETIN-A CREAM 0.05%0.05 %Cream · Topical1 TubeSAR 21.10Generic · PrescriptionJanssen-Cilag International NVWithdrawn by MAH · Not Marketed
RETIN-A GEL 0.025%0.025 %Gel · Topical1 TubeSAR 20.75Generic · PrescriptionJanssen-Cilag International NVWithdrawn by MAH · Not Marketed
SMOODERM CREAM0.05 %Cream · Topical1 TubeSAR 14.40Generic · PrescriptionDAR ALDAWAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

PHYMATOUS ROSACEA (MILD TO MODERATE); SYSTEMIC LUPUS ERYTHEMATOSUS

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

ProductStrengthForm · routeApplicantStatusFirst approved
RETIN-A0.1%cream · topicalBAUSCHPrescription26 Jan 1973
RETIN-A0.05%cream · topicalBAUSCHPrescription19 Jul 1974
RETIN-A0.025%gel · topicalVALEANT INTLPrescription18 Apr 1975
RETIN-A0.01%gel · topicalBAUSCHPrescription17 Oct 1978
RETIN-A0.025%cream · topicalBAUSCHPrescription16 Sep 1988
AVITA0.025%cream · topicalMYLAN PHARMS INCPrescription14 Jan 1997
RETIN-A MICRO0.1%; 0.04%gel · topicalBAUSCHPrescription7 Feb 1997
RETIN-A-MICRO0.08%; 0.06%gel · topicalBAUSCHPrescription7 Feb 1997
TRETINOIN0.1%cream · topicalPADAGIS USPrescription24 Dec 1998
TRETINOIN0.025%cream · topicalPADAGIS USPrescription24 Dec 1998
TRETINOIN0.05%cream · topicalPADAGIS USPrescription24 Dec 1998
TRETINOIN0.025%gel · topicalPADAGIS USPrescription22 Feb 2000
RENOVA0.02%cream · topicalVALEANT PHARMS NORTHPrescription31 Aug 2000
TRETINOIN0.01%gel · topicalPADAGIS USPrescription11 Jun 2002
ATRALIN0.05%gel · topicalDOW PHARMPrescription26 Jul 2007
TRETINOIN10MGcapsule · oralPH HEALTHPrescription24 Oct 2012
TRETINOIN0.05%gel · topicalMYLANPrescription13 Aug 2015
TRETINOIN10MGcapsule · oralGLENMARK PHARMS LTDPrescription23 Dec 2016
ALTRENO0.05%lotion · topicalDOW PHARMPrescription23 Aug 2018
TRETINOIN0.1%cream · topicalSUN PHARMA CANADAPrescription22 Jan 2019
TRETINOIN0.05%cream · topicalSUN PHARMA CANADAPrescription25 Jan 2019
TRETINOIN0.025%cream · topicalSUN PHARMA CANADAPrescription5 Jan 2023
TRETINOIN MICROSPHERE0.08%; 0.06%gel · topicalENCUBEPrescription22 Aug 2023
TRETINOIN0.1%cream · topicalZYDUS LIFESCIENCESPrescription25 Apr 2024
TRETINOIN0.1%cream · topicalALEMBICPrescription29 Apr 2024

24 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
JAMP TRETINOIN0252003610 MGCAPSULE · ORALJAMP PHARMA CORPORATION
RETIN-A004437940.05 % / W/WCREAM · TOPICALBAUSCH HEALTH, CANADA INC.
RETIN-A004438160.025 % / W/WGEL · TOPICALBAUSCH HEALTH, CANADA INC.
RETIN-A MICRO022439140.1 % / W/WGEL · TOPICALBAUSCH HEALTH, CANADA INC.
RETIN-A MICRO022646330.04 % / W/WGEL · TOPICALBAUSCH HEALTH, CANADA INC.
VESANOID0214583910 MGCAPSULE · ORALCHEPLAPHARM ARZNEIMITTEL GMBH
VITAMIN A ACID019264700.025 %GEL · TOPICALBAUSCH HEALTH, CANADA INC.
VITAMIN A ACID019264890.05 %GEL · TOPICALBAUSCH HEALTH, CANADA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACTRETINOIN 0.01% GEL$2.73988per GM23 Sep 2026
US NADACTRETINOIN 0.01% GEL$2.3019per GM23 Sep 2026
US NADACTRETINOIN 0.025% CREAM$0.55294per GM23 Sep 2026
US NADACTRETINOIN 0.025% CREAM$0.45929per GM23 Sep 2026
US NADACTRETINOIN 0.025% GEL$3.54983per GM23 Sep 2026
US NADACTRETINOIN 0.025% GEL$2.50019per GM23 Sep 2026
US NADACTRETINOIN 0.05% CREAM$1.61765per GM23 Sep 2026
US NADACTRETINOIN 0.05% CREAM$1.05049per GM23 Sep 2026
US NADACTRETINOIN 0.05% GEL$3.93282per GM23 Sep 2026
US NADACTRETINOIN 0.1% CREAM$0.91963per GM23 Sep 2026
US NADACTRETINOIN 0.1% CREAM$0.77008per GM23 Sep 2026
US NADACTRETINOIN 10 MG CAPSULE$8.53098per EA23 Sep 2026
NHS Drug TariffTretinoin 10mg capsules£420.00100 capsule1 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 10 Sep 2025 RETIN-A MICRO — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 4 Oct 2024 VESANOID — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 2 Dec 2019 SOLAGE — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for tretinoin →

Combinations containing Tretinoin

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.