Adapalene

Product NDC: 0093-6301
11-digit product format: 000936301
Labeler code: 0093
Product ID: 0093-6301_82f52f42-7b25-4153-8aaf-1d68e1486554
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Adapalene
Dosage form: GEL
Route: TOPICAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA090962
Marketing category: ANDA
Marketing start: 2010-06-02
Marketing end: 2021-09-30
Substance: ADAPALENE
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0093-6301		D	Discontinued by firm		2026-08-17
excluded package	package	0093-6301	0093-6301-95	D	Discontinued by firm		2026-08-17

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 · 24 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	0093-6301-95	`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	0093-6301-95	`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	0093-6301-95	`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	0093-6301-95	`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	0093-6301-95	`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	0093-6301-95	`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	0093-6301-95	`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	0093-6301-95	`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	0093-6301-95	`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	0093-6301-95	`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	0093-6301-95	`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	0093-6301-95	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090962-001	ADAPALENE	ADAPALENE	0.1%	GEL / TOPICAL			2010-06-02

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 · 42 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
2026-08-18 06:07:40	2026-07	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-06-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-06-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-06-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090962-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090962-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090962-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090962-001	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
91d0a1ed-5d14-5017-c7aa-3602ee038695	Product name	3	20210111
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
5c3dfd42-8936-4261-a420-cfcbbf3030aa	Product name	2	20161206
08f39758-2d46-8afe-73ca-39fe69052a2b	Product name	1	20140508
8ae7bcde-1dd2-b073-852b-f464987f7427	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
0093-6301-95	GM - Gram	0093-6301	828aa75a-03df-4bc0-9bfd-9a11401bf583	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ADAPALENE	ACTIVE INGREDIENT	1L4806J2QF	ADAPALENE GEL [TEVA PHARMACEUTICALS USA INC]	2
ADAPALENE	ACTIVE MOIETY	1L4806J2QF	ADAPALENE GEL [TEVA PHARMACEUTICALS USA INC]	2
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	ADAPALENE GEL [TEVA PHARMACEUTICALS USA INC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ADAPALENE GEL [TEVA PHARMACEUTICALS USA INC]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ADAPALENE GEL [TEVA PHARMACEUTICALS USA INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ADAPALENE GEL [TEVA PHARMACEUTICALS USA INC]	2
POLOXAMER 182	INACTIVE INGREDIENT	JX0HIX6OAG	ADAPALENE GEL [TEVA PHARMACEUTICALS USA INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ADAPALENE GEL [TEVA PHARMACEUTICALS USA INC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ADAPALENE GEL [TEVA PHARMACEUTICALS USA INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ADAPALENE GEL [TEVA PHARMACEUTICALS USA INC]	2
ADAPALENE	ACTIVE INGREDIENT	1L4806J2QF	ADAPALENE GEL [PHYSICIANS TOTAL CARE, INC.]	1
ADAPALENE	ACTIVE MOIETY	1L4806J2QF	ADAPALENE GEL [PHYSICIANS TOTAL CARE, INC.]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	ADAPALENE GEL [PHYSICIANS TOTAL CARE, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ADAPALENE GEL [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ADAPALENE GEL [PHYSICIANS TOTAL CARE, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ADAPALENE GEL [PHYSICIANS TOTAL CARE, INC.]	1
POLOXAMER 182	INACTIVE INGREDIENT	JX0HIX6OAG	ADAPALENE GEL [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ADAPALENE GEL [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ADAPALENE GEL [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ADAPALENE GEL [PHYSICIANS TOTAL CARE, 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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adapalene	ADAPALENE	Safeway, Inc.	a9816181-d643-4579-8b12-3927120dc627	2026-06-18	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment	ADAPALENE	Kenvue Brands LLC	4dfe533e-d3dc-b7ff-e063-6394a90ac61b	2026-04-08	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	The Kroger Co.	1238c72c-1c51-46e4-b15c-61093b03608e	2026-03-23	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	P & L Development, LLC	e9155950-6c92-4f57-851a-51be6ba9062f	2025-12-16	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	YYBA CORP	44eb8cf6-d8ed-0e08-e063-6394a90ac8ef	2025-12-01	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	Topco Associates	5693e3c9-00e5-4e62-b44a-47be2dc31811	2025-10-06	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatment	ADAPALENE	Kenvue Brands LLC	3f9b75cf-75aa-9012-e063-6294a90a6469	2025-10-01	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	Meijer Distribution Inc.	f2c25c70-87b7-482f-b23a-467008761a3e	2025-09-09	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	Walgreens	2c1cdc03-087d-43b0-b0b3-503a35398a53	2025-05-16	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	Walgreens	84ab65a4-b343-4ad9-8049-aea1ec029031	2025-03-12	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Neutrogena Adapalene 0.1% Acne Treatment	ADAPALENE	Kenvue Brands LLC	0682cb55-6ae3-437f-e063-6294a90ac510	2024-11-12	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
Adapalene	ADAPALENE	CVS PHARMACY, INC	ff9a929e-121b-42b4-8e79-f8f46c22a8be	2024-02-21	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1L4806J2QF	ADAPALENE	106685-40-9	ADAPALENE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307731	adapalene 0.1 % Topical Gel	PSN	a81f2db7-78b0-45fd-93cc-b7fe43bcb45a	1
307731	adapalene 0.001 MG/MG Topical Gel	SCD	a81f2db7-78b0-45fd-93cc-b7fe43bcb45a	1
307731	adapalene 0.1 % Topical Gel	SY	a81f2db7-78b0-45fd-93cc-b7fe43bcb45a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-6301-95	00093630195	45 g in 1 TUBE (0093-6301-95)	45 g	2010-06-02	2021-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ADAPALENE GEL, 0.1% Rx only 6301	Teva Pharmaceuticals USA, Inc.	2020-10-28	HUMAN PRESCRIPTION DRUG LABEL	7
ADAPALENE GEL, 0.1%	Physicians Total Care, Inc.	2010-06-02	HUMAN PRESCRIPTION DRUG LABEL	1