Tretinoin

Product NDC: 43478-243
11-digit product format: 434780243
Labeler code: 43478
Product ID: 43478-243_a61787f3-f3c8-4ea7-b659-f1ba1655336b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: Rouses Point
Application: ANDA075264
Marketing category: ANDA
Marketing start: 1998-12-24
Marketing end: 2019-04-01
Substance: TRETINOIN
Active strength: 0 mg/g
Pharmacologic classes: Retinoid [EPC],
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	43478-243		D	Discontinued by firm	2026-08-03
excluded package	package	43478-243	43478-243-20	D	Discontinued by firm	2026-08-03
excluded package	package	43478-243	43478-243-45	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	43478-243-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43478-243-20	`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	43478-243-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43478-243-20	`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	43478-243-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43478-243-20	`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	43478-243-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43478-243-20	`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	43478-243-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43478-243-20	`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	43478-243-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43478-243-20	`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	43478-243-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43478-243-20	`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	43478-243-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43478-243-20	`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	43478-243-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43478-243-20	`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	43478-243-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43478-243-20	`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	43478-243-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43478-243-20	`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	43478-243-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43478-243-20	`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
A075264-001	TRETINOIN	TRETINOIN	0.025%	CREAM / TOPICAL	AB		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
A075264-001	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.

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	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	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	A075264-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075264-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075264-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075264-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075264-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075264-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075264-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075264-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075264-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075264-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075264-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075264-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075264-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075264-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075264-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075264-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075264-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075264-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075264-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075264-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075264-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075264-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075264-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075264-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075264-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075264-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075264-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075264-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075264-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075264-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075264-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075264-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075264-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075264-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075264-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075264-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075264-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075264-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075264-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075264-001	AB	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
503b047e-e62d-4745-9011-522b13bc701b	Product name	1	20181206
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
7d41caa2-0b5d-9b03-ab8d-84271de26ef4	Product name	2	20170314
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
50ca9ff5-82dd-9971-4f2c-5845a76a8572	Product name	2	20150818
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
43478-243-20	GM - Gram	43478-243	049078f2-14ec-4f4f-a11c-c3cec97550d0	1	2012-07-24
43478-243-45	GM - Gram	43478-243	836eb77e-5ba9-46f1-94bd-053bd1c5b5c4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL, UNSPECIFIED FORM	ACTIVE INGREDIENT	L7T10EIP3A	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
TRETINOIN	ACTIVE INGREDIENT	5688UTC01R	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
TRETINOIN	ACTIVE INGREDIENT	5688UTC01R	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
MENTHOL, UNSPECIFIED FORM	ACTIVE MOIETY	L7T10EIP3A	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
TRETINOIN	ACTIVE MOIETY	5688UTC01R	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
TRETINOIN	ACTIVE MOIETY	5688UTC01R	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
BRUCINE SULFATE	INACTIVE INGREDIENT	KY7O12XPOQ	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
CHLOROTHYMOL	INACTIVE INGREDIENT	LJ25TI0CVT	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	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
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
TERT-BUTYL ALCOHOL	INACTIVE INGREDIENT	MD83SFE959	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
THYMOL	INACTIVE INGREDIENT	3J50XA376E	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, 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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRETINOIN	TRETINOIN	Preferred Pharmaceuticals Inc.	d6819051-4748-479e-8b53-c298edcbd410	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264
TRETINOIN	TRETINOIN	NuCare Pharmaceuticals,Inc.	47fc341b-8cff-9d63-e063-6394a90abdfd	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264
TRETINOIN	TRETINOIN	Bryant Ranch Prepack	5e84c976-d4d6-4d8f-a448-8afb47e2fbff	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264
TRETINOIN	TRETINOIN	A-S Medication Solutions	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264
TRETINOIN	TRETINOIN	Padagis US LLC	4889c7f8-37d0-4f1a-9829-bca107806586	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264

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
1946481	Calmoseptine 15.7 % / 0.44 % / 24 % / 20.6 % Topical Ointment	PSN	24682288-1be4-42af-e054-00144ff88e88	1
1946476	lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment	PSN	24682288-1be4-42af-e054-00144ff88e88	1
106302	tretinoin 0.025 % Topical Cream	PSN	f5ce22e8-1a9b-408c-86ae-4084b7afeca1	1
106302	tretinoin 0.025 % Topical Cream	PSN	24682288-1be4-42af-e054-00144ff88e88	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
1946481	lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calmoseptine]	SBD	24682288-1be4-42af-e054-00144ff88e88	1
1946476	lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment	SCD	24682288-1be4-42af-e054-00144ff88e88	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	24682288-1be4-42af-e054-00144ff88e88	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
1946481	Calmoseptine Ointment (lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG) Topical Ointment	SY	24682288-1be4-42af-e054-00144ff88e88	1
1946481	Calmoseptine OIntment (lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % ) Topical Ointment	SY	24682288-1be4-42af-e054-00144ff88e88	1
1946476	Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment	SY	24682288-1be4-42af-e054-00144ff88e88	1
1946481	Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calmoseptine]	SY	24682288-1be4-42af-e054-00144ff88e88	1
1946476	lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment	SY	24682288-1be4-42af-e054-00144ff88e88	1
106302	tretinoin 0.025 % Topical Cream	SY	24682288-1be4-42af-e054-00144ff88e88	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
DERMAWERX ZMT PAK	Patchwerx Labs, Inc. \| Calmo Manufacturing Inc \| BASF Pharmachemikalien GmbH & Co . KG \| DPT Laboratories, Ltd.	2015-11-13	HUMAN PRESCRIPTION DRUG LABEL	1
Tretinoin	Rebel Distributors Corp	2011-03-15	HUMAN PRESCRIPTION DRUG LABEL	1