Tretinoin Cream, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-04-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:02:42

Label at a glance#

ProductTretinoin

Active ingredientTRETINOIN

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1873-2

Tretinoin cream USP, 0.1%

20 grams

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198300	tretinoin 0.1 % Topical Cream	PSN	1
198300	tretinoin 1 MG/ML Topical Cream	SCD	1
198300	tretinoin 0.1 % Topical Cream	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TRETINOIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60	Product name	6	20251124
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ec	Product name	2	20250521
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
503b047e-e62d-4745-9011-522b13bc701b	Product name	1	20181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4	Product name	2	20170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572	Product name	2	20150818
0a8118e4-08c6-b395-9ddc-d3e425e0493a	Product name	1	20140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579	Product name	1	20140508
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1873-2	Tretinoin	1 in 1 CARTON	CREAM	1	1
70771-1873-2	Tretinoin	20 g in 1 TUBE	CREAM	20	1
70771-1873-4	Tretinoin	1 in 1 CARTON	CREAM	1	1
70771-1873-4	Tretinoin	45 g in 1 TUBE	CREAM	45	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1873	TRETINOIN CREAM [ZYDUS LIFESCIENCES LIMITED]	1	Current NDC, 4 package rows	20240501_047989fc-6e33-4f19-8ba7-5fb63bb06cf3.zip

Products#

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

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

Tretinoin
BUTYLATED HYDROXYTOLUENE
ISOPROPYL MYRISTATE
POLYOXYL 40 STEARATE
SORBIC ACID
STEARIC ACID
STEARYL ALCOHOL
WATER
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1873	70771-1873-2, 70771-1873-4

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
Name	UNII	Kind
TRETINOIN	5688UTC01R	ACTIB
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
POLYOXYL 40 STEARATE	13A4J4NH9I	IACT
SORBIC ACID	X045WJ989B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	IACT

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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218561-001	TRETINOIN	TRETINOIN	0.1%	CREAM / TOPICAL	AB		2024-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218561-001	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218561-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2024-04-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218561-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218561-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218561-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218561-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218561-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218561-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218561-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218561-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218561-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218561-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218561-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218561-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218561-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218561-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218561-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218561-001	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218561-001	AB	1	`a50c72e98297…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Zydus Lifesciences Limited	047989fc-6e33-4f19-8ba7-5fb63bb06cf3	2024-04-26		Exact identifier ndc (package): 70771-1873-4 ndc (package): 70771-1873-2 ndc (product): 70771-1873 ndc11 (package): 70771187302 ndc11 (package): 70771187304 spl id: 650ffd6d-e4dd-49df-be9e-da611704dc40 spl set id: 047989fc-6e33-4f19-8ba7-5fb63bb06cf3

Reported adverse events (FAERS/openFDA)#

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