Tretinoin Cream

Product NDC: 62032-412
Requested package NDC: 62032-412-20
11-digit product format: 620320412
Labeler code: 62032
Product ID: 62032-412_c96be1f7-0c29-4bc7-ac51-c3da8b4788fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: Obagi Cosmeceuticals LLC
Application: NDA017522
Marketing category: NDA
Marketing start: 1974-07-19
Substance: TRETINOIN
Active strength: .5 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62032-412	62032-412-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62032-412	62032-412-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62032-412	62032-412-20	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N017522-001	RETIN-A	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017522-001	AB1

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017522-001	RETIN-A	0.05%	CREAM / TOPICAL	AB1	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017522-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017522-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017522-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017522-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017522-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017522-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017522-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017522-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017522-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017522-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017522-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017522-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017522-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017522-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017522-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017522-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017522-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017522-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017522-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017522-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017522-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017522-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017522-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017522-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017522-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017522-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017522-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017522-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017522-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017522-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017522-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017522-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017522-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017522-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017522-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017522-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017522-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017522-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017522-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017522-001	AB1	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tretinoin Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRETINOIN	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5688UTC01R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106302	Internal RxNorm lookup
106303	Internal RxNorm lookup
198300	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
745cc3ce-60b4-4479-a055-316817567949	Available on FDA.report

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62032-412-20	2025-02-11	C162847	48780-1	2cef2736-5adc-d83d-e063-dadaa90ab31f	TRETINOIN CREAM
62032-412-20	2025-01-30	C162847	48780-1	2cef2736-5adc-d83d-e063-dadaa90ab31f	TRETINOIN CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62032-412-20	Tretinoin Cream	1 in 1 CARTON	CREAM	1		13
62032-412-20	Tretinoin Cream	20 g in 1 TUBE	CREAM	20		13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRETINOIN	ACTIVE INGREDIENT	5688UTC01R	TRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]	4
TRETINOIN	ACTIVE MOIETY	5688UTC01R	TRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	TRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]	4
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]	4
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	TRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]	4
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	TRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]	4
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	TRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62032-412	TRETINOIN CREAM (TRETINOIN) CREAM [OBAGI COSMECEUTICALS LLC]	13	Current NDC, Legacy NDC, 2 package rows	20250213_745cc3ce-60b4-4479-a055-316817567949.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin Cream	TRETINOIN	Obagi Cosmeceuticals LLC	745cc3ce-60b4-4479-a055-316817567949	2025-02-11	Adverse reactions	Exact identifier application applno (NDA): 017522 application number: NDA017522 ndc (package): 62032-412-20 ndc (product): 62032-412 ndc11 (package): 62032041220
Tretinoin	TRETINOIN	Mylan Pharmaceuticals Inc.	ba377a5e-e48a-4bd9-9d76-929d70793396	2024-10-09	Adverse reactions	Exact identifier application applno (NDA): 017522 application number: NDA017522
Retin-A	TRETINOIN	Bausch Health US, LLC	9556d73d-c573-4e0a-9feb-764ce2d1107b	2024-05-17	Adverse reactions	Exact identifier application applno (NDA): 017522 application number: NDA017522

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5688UTC01R	TRETINOIN	302-79-4	TRETINOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106302	tretinoin 0.025 % Topical Cream	PSN	745cc3ce-60b4-4479-a055-316817567949	13
106303	tretinoin 0.05 % Topical Cream	PSN	745cc3ce-60b4-4479-a055-316817567949	13
198300	tretinoin 0.1 % Topical Cream	PSN	745cc3ce-60b4-4479-a055-316817567949	13
106302	tretinoin 0.25 MG/ML Topical Cream	SCD	745cc3ce-60b4-4479-a055-316817567949	13
106303	tretinoin 0.5 MG/ML Topical Cream	SCD	745cc3ce-60b4-4479-a055-316817567949	13
198300	tretinoin 1 MG/ML Topical Cream	SCD	745cc3ce-60b4-4479-a055-316817567949	13
106302	tretinoin 0.025 % Topical Cream	SY	745cc3ce-60b4-4479-a055-316817567949	13
106303	tretinoin 0.05 % Topical Cream	SY	745cc3ce-60b4-4479-a055-316817567949	13
198300	tretinoin 0.1 % Topical Cream	SY	745cc3ce-60b4-4479-a055-316817567949	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62032-412-20	62032041220	1 TUBE in 1 CARTON (62032-412-20) / 20 g in 1 TUBE	1 tube	1974-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRETINOIN CREAM	Obagi Cosmeceuticals LLC \| Bausch Health Companies Inc.	2025-02-11	HUMAN PRESCRIPTION DRUG LABEL	13