OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Retin-A

Tretinoin · Cream

Prescription NDA TE AB RLD
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
Retin-A
Generic name
Tretinoin
Dosage form
Cream
Route
Topical
Marketing category
NDA · NDA
Labeler
Bausch Health US, LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
6
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
Tretinoin .25 mg/g 106302 View
Tretinoin .5 mg/g 106302 View
Tretinoin 1 mg/g 106302 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Cream
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
017340
Application type
NDA · New Drug Application
Approval date
January 26, 1973
Sponsor
BAUSCH
Products on application
1
Submissions recorded
30
Products approved under application 017340.
Product Trade name Form Strength Ingredient Status TE Flags
017340-001 RETIN-A CREAM TRETINOIN Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 017340.
Type No. Action Status Date Review
Supplement 48 Manufacturing (CMC) Approved May 13, 2016 Standard
Supplement 47 Manufacturing (CMC) Approved December 17, 2015 Standard
Supplement 46 Manufacturing (CMC) Approved January 8, 2013 Standard
Supplement 38 Manufacturing (CMC) Approved December 6, 2002 Standard
Supplement 36 Labeling Approved June 10, 2002 Standard
Supplement 33 Labeling Approved June 10, 2002 Standard
Supplement 32 Labeling Approved June 10, 2002 Standard
Supplement 37 Manufacturing (CMC) Approved March 20, 2001 Standard
Supplement 35 Manufacturing (CMC) Approved January 25, 1999 Standard
Supplement 34 Manufacturing (CMC) Approved July 23, 1998 Standard
Supplement 30 Manufacturing (CMC) Approved January 24, 1992 Standard
Supplement 28 Labeling Approved August 28, 1990 —
Supplement 27 Labeling Approved August 28, 1990 —
Supplement 29 Manufacturing (CMC) Approved July 3, 1990 Standard
Supplement 26 Manufacturing (CMC) Approved December 1, 1989 Standard
Supplement 25 Labeling Approved April 12, 1989 —
Supplement 23 Manufacturing (CMC) Approved August 26, 1986 Standard
Supplement 21 Manufacturing (CMC) Approved July 24, 1986 Standard
Supplement 22 Manufacturing (CMC) Approved June 11, 1985 Standard
Supplement 20 Manufacturing (CMC) Approved March 30, 1984 Standard
Supplement 19 Manufacturing (CMC) Approved June 6, 1983 Standard
Supplement 17 Labeling Approved December 13, 1982 —
Supplement 18 Manufacturing (CMC) Approved July 28, 1981 Standard
Supplement 15 Labeling Approved December 4, 1978 —
Supplement 14 Labeling Approved January 4, 1977 —
Supplement 13 Manufacturing (CMC) Approved June 30, 1976 Standard
Supplement 10 Manufacturing (CMC) Approved August 27, 1974 Standard
Supplement 9 Supplement Approved April 15, 1974 Standard
Supplement 7 Supplement Approved April 15, 1974 Standard
Original application 1 Type 3 - New Dosage Form Approved January 26, 1973 Standard

Review documents

  • 0 · Supplement · June 10, 2002
  • 0 · Supplement · June 10, 2002
  • 0 · Supplement · June 10, 2002
  • 0 · Supplement · June 10, 2002
  • 0 · Supplement · June 10, 2002
  • 0 · Supplement · June 10, 2002

Adverse event reports

Source: openFDA FAERS
8,793
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: TRETINOIN. 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
0187-5160-20 0187-5160 Bausch Health US, LLC 1 TUBE in 1 CARTON (0187-5160-20) / 20 g in 1 TUBE October 30, 1988
0187-5160-45 0187-5160 Bausch Health US, LLC 1 TUBE in 1 CARTON (0187-5160-45) / 45 g in 1 TUBE October 30, 1988
0187-5162-20 0187-5162 Bausch Health US, LLC 1 TUBE in 1 CARTON (0187-5162-20) / 20 g in 1 TUBE July 30, 1974
0187-5162-45 0187-5162 Bausch Health US, LLC 1 TUBE in 1 CARTON (0187-5162-45) / 45 g in 1 TUBE July 30, 1974
0187-5164-20 0187-5164 Bausch Health US, LLC 1 TUBE in 1 CARTON (0187-5164-20) / 20 g in 1 TUBE April 30, 1973
0187-5164-45 0187-5164 Bausch Health US, LLC 1 TUBE in 1 CARTON (0187-5164-45) / 45 g in 1 TUBE April 30, 1973
0187-5160 0187-5160 Bausch Health US, LLC — October 30, 1988
0187-5162 0187-5162 Bausch Health US, LLC — July 30, 1974
0187-5164 0187-5164 Bausch Health US, LLC — April 30, 1973

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
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.