FDA.reportPublic FDA data

Tretinoin Cream USP, 0.025%

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-09-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-02 01:07:39

Label at a glance#

ProductTretinoin
Active ingredientTRETINOIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1933-2

Tretinoin cream USP, 0.025%

20 grams

tube label
tube label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372578155094GTIN-13: 0372578155094
EAN-13: 0372578155094
GTIN-12: 372578155094
UPC-A: 372578155094
GTIN storage (14 digits): 00372578155094		1df91300-7a8d-4354-8451-512247804a71-01.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-193370771-1933-2, 70771-1933-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRETINOIN5688UTC01RACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYOXYL 40 STEARATE TYPE I13A4J4NH9IIACT
SORBIC ACIDX045WJ989BIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218560-001TRETINOINTRETINOIN0.025%CREAM / TOPICALAB2026-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218560-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A218560-001TRETINOIN0.025%CREAM / TOPICALAB2026-09-15c2088c7a36db…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A218560-001AB1c2088c7a36db…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TretinoinTRETINOINPar Health USA, LLC9c4ae9d9-c2a0-4995-a27a-e3f0f0284db92026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TretinoinTRETINOINRedpharm Drug57d1e8ed-ffc8-5e19-e063-6294a90af9412026-07-30Warnings, Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TretinoinTRETINOINAlembic Pharmaceuticals Limited5304df69-5d29-48f5-8227-80c7a6f12e6d2026-07-01Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TretinoinTRETINOINAlembic Pharmaceuticals Inc.49e542a3-57cc-482f-9118-4174c80742dd2026-06-26Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TretinoinTRETINOINMajor Pharmaceuticals045258e2-5efb-4147-bf74-4c43af04dccc2026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TretinoinTRETINOINAmneal Pharmaceuticals NY LLC4b6006e3-f7a4-4823-8217-3e5b0f7e58d92026-04-29Warnings, Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TRETINOINTRETINOINEncube Ethicals, Inc.57558405-42fa-40bb-a61c-48e030d976de2026-04-16Warnings, Adverse reactionsName fallback
brand name: TRETINOIN
generic name: TRETINOIN
TRETINOINTRETINOINREMEDYREPACK INC.c4d5155b-046d-4f94-bafc-651b572c2bd52026-04-07Warnings, Adverse reactionsName fallback
brand name: TRETINOIN
generic name: TRETINOIN
TretinoinTRETINOINEncube Ethicals, Inc.5e3fb8ea-234c-4be2-95a7-d139e069cf982026-03-31Warnings, Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TretinoinTRETINOINBryant Ranch Prepack2b58cf56-e713-4cdd-8b4e-e6651ef766502026-03-04Warnings, Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
RenovaTRETINOINBausch Health US LLC9f0a0e8d-1051-48a4-80c5-1bd260dd9c362026-02-24Warnings, Adverse reactionsName fallback
generic name: TRETINOIN
TretinoinTRETINOINA-S Medication Solutions44be2556-1ea9-49e9-86dd-991fbcc6348d2026-02-02Warnings, Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TretinoinTRETINOINGlenmark Pharmaceuticals Inc., USA264138c1-9e5f-45ef-be87-79ca97c989d92026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TRETINOINTRETINOINPreferred Pharmaceuticals Inc.d6819051-4748-479e-8b53-c298edcbd4102026-01-28Warnings, Adverse reactionsName fallback
brand name: TRETINOIN
generic name: TRETINOIN
TretinoinTRETINOINAlembic Pharmaceuticals Inc.872b3f8f-c073-4808-a106-840188ac7a002026-01-23Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TRETINOINTRETINOINNuCare Pharmaceuticals,Inc.47fc341b-8cff-9d63-e063-6394a90abdfd2026-01-09Warnings, Adverse reactionsName fallback
brand name: TRETINOIN
generic name: TRETINOIN
TretinoinTRETINOINAmerican Health Packagingb22d5a07-623a-4645-b87d-a151b86da8d52025-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TretinoinTRETINOINBryant Ranch Prepack04f14d6e-5b44-44bd-a7f3-d684d9c5d7cb2025-10-21Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TretinoinTRETINOINBryant Ranch Prepacka1ae0000-3411-47e5-94f2-ae2ee70eadfb2025-10-21Adverse reactionsName fallback
brand name: Tretinoin
generic name: TRETINOIN
TRETINOINTRETINOINBryant Ranch Prepack8929196c-389a-4c43-843c-00fbb26a1dd92025-10-17Warnings, Adverse reactionsName fallback
brand name: TRETINOIN
generic name: TRETINOIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.