Tretinoin

Product NDC: 71335-2898
11-digit product format: 713352898
Labeler code: 71335
Product ID: 71335-2898_ca82745d-d880-4b6a-af76-97b8ce1519ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tretinoin
Dosage form: GEL
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: NDA017579
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-07-12
Substance: TRETINOIN
Active strength: .25 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
N017579-002	RETIN-A	TRETINOIN	0.025%	GEL / TOPICAL	AB	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
N017579-002	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.

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	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017579-002	RETIN-A	0.025%	GEL / TOPICAL	AB	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	N017579-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017579-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017579-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017579-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017579-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017579-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017579-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017579-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017579-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017579-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017579-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017579-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017579-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017579-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017579-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017579-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017579-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017579-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017579-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017579-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017579-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017579-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017579-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017579-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017579-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017579-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017579-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017579-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017579-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017579-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017579-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017579-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017579-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017579-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017579-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017579-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017579-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017579-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017579-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017579-002	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRETINOIN	.25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313451	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
a1ae0000-3411-47e5-94f2-ae2ee70eadfb	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-2898-1	Tretinoin	45 g in 1 TUBE	GEL	45		100
71335-2898-1	Tretinoin	1 in 1 CARTON	GEL	1		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2898-1	GM - Gram	71335-2898	ae317241-d58e-4acd-a595-2e9f786c122e	1	2025-12-16

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	TRETINOIN	Bryant Ranch Prepack	a1ae0000-3411-47e5-94f2-ae2ee70eadfb	2025-10-21	Adverse reactions	Exact identifier application applno (NDA): 017579 application number: NDA017579 ndc (product): 71335-2898
Tretinoin	TRETINOIN	Mylan Pharmaceuticals Inc.	ba377a5e-e48a-4bd9-9d76-929d70793396	2024-10-09	Adverse reactions	Exact identifier application applno (NDA): 017579 application number: NDA017579
Retin-A	TRETINOIN	Bausch Health US, LLC	9556d73d-c573-4e0a-9feb-764ce2d1107b	2024-05-17	Adverse reactions	Exact identifier application applno (NDA): 017579 application number: NDA017579

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
313451	tretinoin 0.025 % Topical Gel	PSN	a1ae0000-3411-47e5-94f2-ae2ee70eadfb	100
313451	tretinoin 0.00025 MG/MG Topical Gel	SCD	a1ae0000-3411-47e5-94f2-ae2ee70eadfb	100
313451	tretinoin 0.025 % Topical Gel	SY	a1ae0000-3411-47e5-94f2-ae2ee70eadfb	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2898-1	71335289801	1 TUBE in 1 CARTON (71335-2898-1) / 45 g in 1 TUBE	1 tube	2025-10-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRETINOIN CREAM – TRETINOIN GEL	Bryant Ranch Prepack	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	100