Tretinoin

Product NDC: 0378-8093
11-digit product format: 003788093
Labeler code: 0378
Product ID: 0378-8093_c9f92ca9-5c8e-4a76-9304-a92bc552246b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tretinoin
Dosage form: GEL
Route: TOPICAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA020475
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-12-17
Marketing end: 0000-00-00
Substance: TRETINOIN
Active strength: 1 mg/g
Pharmacologic classes: Retinoid [EPC],Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-8093		D	Discontinued by firm	2026-08-03
excluded package	package	0378-8093	0378-8093-20	D	Discontinued by firm	2026-08-03
excluded package	package	0378-8093	0378-8093-45	D	Discontinued by firm	2026-08-03
excluded package	package	0378-8093	0378-8093-50	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 · 8 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	0378-8093-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-8093-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-8093-20	`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	0378-8093-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-8093-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-8093-20	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020475-001	RETIN-A MICRO	TRETINOIN	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07
N020475-002	RETIN-A MICRO	TRETINOIN	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10
N020475-003	RETIN-A-MICRO	TRETINOIN	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28
N020475-004	RETIN-A-MICRO	TRETINOIN	0.06%	GEL / TOPICAL	AB	RLD, RS	2017-10-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020475-003	AB
N020475-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020475-001	RETIN-A MICRO	0.1%	GEL / TOPICAL		RLD, RS	1997-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020475-002	RETIN-A MICRO	0.04%	GEL / TOPICAL		RLD, RS	2002-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020475-003	RETIN-A-MICRO	0.08%	GEL / TOPICAL	AB	RLD, RS	2014-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020475-004	RETIN-A-MICRO	0.06%	GEL / TOPICAL		RLD, RS	2017-10-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020475-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020475-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020475-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020475-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020475-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020475-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020475-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020475-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020475-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020475-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020475-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020475-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020475-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020475-003	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N020475-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020475-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020475-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020475-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020475-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020475-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020475-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020475-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020475-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020475-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020475-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020475-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020475-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020475-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020475-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020475-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020475-003	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020475-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020475-004	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-8093-20	GM - Gram	0378-8093	a85555c8-8c90-49c1-a15c-edbc9679b92e	1	2019-01-24
0378-8093-45	GM - Gram	0378-8093	808d9006-f3ce-4e1c-ac70-85e51e4da91a	1	2019-01-24
0378-8093-50	GM - Gram	0378-8093	e1cf1897-ff9f-48c7-b8e5-a3ac4e03f1ec	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-8093	TRETINOIN GEL [MYLAN PHARMACEUTICALS INC.]	9	Legacy NDC	20240824_ff10a007-5814-4794-8ce3-da5cc85fca85.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Oceanside Pharmaceuticals	d3c528d2-429d-4f37-9ebf-eee8b9fd3050	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020475 application number: NDA020475
Retin-A MICRO	TRETINOIN	Bausch Health US LLC	08ab7e0c-1437-455f-815c-98904d96a289	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020475 application number: NDA020475

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
0378-8093-20	00378809320	1 TUBE in 1 CARTON (0378-8093-20) > 20 g in 1 TUBE	1 tube	2018-12-17	0000-00-00	No	No	Current
0378-8093-45	00378809345	1 TUBE in 1 CARTON (0378-8093-45) > 45 g in 1 TUBE	1 tube	2018-12-17	0000-00-00	No	No	Current
0378-8093-50	00378809350	1 BOTTLE, PUMP in 1 CARTON (0378-8093-50) > 50 g in 1 BOTTLE, PUMP		2019-10-16	0000-00-00	No	No	Current