Tretinoin

Product NDC: 66530-257
11-digit product format: 665300257
Labeler code: 66530
Product ID: 66530-257_6dee9a3b-1c6a-43ac-a6fa-45a17ab4efd6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tretinoin
Dosage form: GEL
Route: TOPICAL
Labeler: Spear Dermatology Products Inc
Application: NDA017579
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-02-06
Marketing end: 2021-06-06
Substance: TRETINOIN
Active strength: 0 mg/g
Pharmacologic classes: Retinoid [EPC],Retinoids [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66530-257		D	Discontinued by firm	2026-08-03
excluded package	package	66530-257	66530-257-15	D	Discontinued by firm	2026-08-03
excluded package	package	66530-257	66530-257-45	D	Discontinued by firm	2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66530-257-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66530-257-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66530-257-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66530-257-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66530-257-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66530-257-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66530-257-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66530-257-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66530-257-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66530-257-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66530-257-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66530-257-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66530-257-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66530-257-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66530-257-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66530-257-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66530-257-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66530-257-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66530-257-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66530-257-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66530-257-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66530-257-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66530-257-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66530-257-15	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRETINOIN	ACTIVE INGREDIENT	5688UTC01R	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
TRETINOIN	ACTIVE MOIETY	5688UTC01R	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
BRUCINE SULFATE HEPTAHYDRATE	INACTIVE INGREDIENT	O900CDH328	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
TERT-BUTYL ALCOHOL	INACTIVE INGREDIENT	MD83SFE959	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TRETINOIN CREAM TRETINOIN GEL [SPEAR DERMATOLOGY PRODUCTS INC]	1

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66530-257-15	66530025715	1 TUBE in 1 CARTON (66530-257-15) > 15 g in 1 TUBE	1 tube	2014-02-06	2021-05-17	No	No	Current
66530-257-45	66530025745	1 TUBE in 1 CARTON (66530-257-45) > 45 g in 1 TUBE	1 tube	2014-02-06	2021-06-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRETINOIN CREAM TRETINOIN GEL FOR TOPICAL USE ONLY	Spear Dermatology Products Inc \| Bausch Health Companies Inc.	2018-10-18	HUMAN PRESCRIPTION DRUG LABEL	7