Tretinoin

Product NDC: 43478-242
11-digit product format: 434780242
Labeler code: 43478
Product ID: 43478-242_a61787f3-f3c8-4ea7-b659-f1ba1655336b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: Rouses Point
Application: ANDA075265
Marketing category: ANDA
Marketing start: 1998-12-24
Marketing end: 2019-08-01
Substance: TRETINOIN
Active strength: 1 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	43478-242		D	Discontinued by firm	2026-08-03
excluded package	package	43478-242	43478-242-20	D	Discontinued by firm	2026-08-03
excluded package	package	43478-242	43478-242-45	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	43478-242-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43478-242-20	`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	43478-242-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43478-242-20	`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	43478-242-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43478-242-20	`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	43478-242-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43478-242-20	`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	43478-242-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43478-242-20	`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	43478-242-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43478-242-20	`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	43478-242-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43478-242-20	`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	43478-242-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43478-242-20	`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	43478-242-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43478-242-20	`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	43478-242-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43478-242-20	`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	43478-242-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43478-242-20	`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	43478-242-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43478-242-20	`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
A075265-001	TRETINOIN	TRETINOIN	0.05%	CREAM / TOPICAL	AB1		1998-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075265-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075265-001	TRETINOIN	0.05%	CREAM / TOPICAL	AB1	1998-12-24	`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	A075265-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075265-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075265-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075265-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075265-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075265-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075265-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075265-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075265-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075265-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075265-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075265-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075265-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075265-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075265-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075265-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075265-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075265-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075265-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075265-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075265-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075265-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075265-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075265-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075265-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075265-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075265-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075265-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075265-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075265-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075265-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075265-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075265-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075265-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075265-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075265-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075265-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075265-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075265-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075265-001	AB1	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43478-242-20	GM - Gram	43478-242	93560464-e615-4193-8e93-d0b7760ac53b	1	2012-07-24
43478-242-45	GM - Gram	43478-242	df9924cd-3420-4b3c-86a4-a59acdb72d1a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRETINOIN	ACTIVE INGREDIENT	5688UTC01R	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
TRETINOIN	ACTIVE MOIETY	5688UTC01R	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
BRUCINE SULFATE	INACTIVE INGREDIENT	KY7O12XPOQ	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
TERT-BUTYL ALCOHOL	INACTIVE INGREDIENT	MD83SFE959	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	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	8929196c-389a-4c43-843c-00fbb26a1dd9	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075265 application number: ANDA075265
TRETINOIN	TRETINOIN	A-S Medication Solutions	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075265 application number: ANDA075265
TRETINOIN	TRETINOIN	Padagis US LLC	4889c7f8-37d0-4f1a-9829-bca107806586	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075265 application number: ANDA075265

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	4af7484c-53e8-4ccb-a387-f20efb7a0bea	6
106303	tretinoin 0.05 % Topical Cream	PSN	4af7484c-53e8-4ccb-a387-f20efb7a0bea	6
198300	tretinoin 0.1 % Topical Cream	PSN	4af7484c-53e8-4ccb-a387-f20efb7a0bea	6
106302	tretinoin 0.25 MG/ML Topical Cream	SCD	4af7484c-53e8-4ccb-a387-f20efb7a0bea	6
106303	tretinoin 0.5 MG/ML Topical Cream	SCD	4af7484c-53e8-4ccb-a387-f20efb7a0bea	6
198300	tretinoin 1 MG/ML Topical Cream	SCD	4af7484c-53e8-4ccb-a387-f20efb7a0bea	6
106302	tretinoin 0.025 % Topical Cream	SY	4af7484c-53e8-4ccb-a387-f20efb7a0bea	6
106303	tretinoin 0.05 % Topical Cream	SY	4af7484c-53e8-4ccb-a387-f20efb7a0bea	6
198300	tretinoin 0.1 % Topical Cream	SY	4af7484c-53e8-4ccb-a387-f20efb7a0bea	6
106302	tretinoin 0.025 % Topical Cream	PSN	f5ce22e8-1a9b-408c-86ae-4084b7afeca1	1
313451	tretinoin 0.025 % Topical Gel	PSN	f5ce22e8-1a9b-408c-86ae-4084b7afeca1	1
106303	tretinoin 0.05 % Topical Cream	PSN	f5ce22e8-1a9b-408c-86ae-4084b7afeca1	1
313451	tretinoin 0.00025 MG/MG Topical Gel	SCD	f5ce22e8-1a9b-408c-86ae-4084b7afeca1	1
106302	tretinoin 0.25 MG/ML Topical Cream	SCD	f5ce22e8-1a9b-408c-86ae-4084b7afeca1	1
106303	tretinoin 0.5 MG/ML Topical Cream	SCD	f5ce22e8-1a9b-408c-86ae-4084b7afeca1	1
106302	tretinoin 0.025 % Topical Cream	SY	f5ce22e8-1a9b-408c-86ae-4084b7afeca1	1
313451	tretinoin 0.025 % Topical Gel	SY	f5ce22e8-1a9b-408c-86ae-4084b7afeca1	1
106303	tretinoin 0.05 % Topical Cream	SY	f5ce22e8-1a9b-408c-86ae-4084b7afeca1	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tretinoin	A-S Medication Solutions	2018-01-22	HUMAN PRESCRIPTION DRUG LABEL	6
Tretinoin	Rebel Distributors Corp	2011-03-15	HUMAN PRESCRIPTION DRUG LABEL	1