Adapalene

Product NDC: 42546-720
11-digit product format: 425460720
Labeler code: 42546
Product ID: 42546-720_8ba7e13b-3c62-4726-adea-8da242edbded
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Adapalene
Dosage form: GEL
Route: TOPICAL
Labeler: PruGen, Inc.
Application: ANDA091314
Marketing category: ANDA
Marketing start: 2016-03-04
Marketing end: 0000-00-00
Substance: ADAPALENE
Active strength: 45 g/g
Pharmacologic classes: Retinoid [EPC],Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42546-720		I	Inactivated by FDA		2026-08-17
excluded package	package	42546-720	42546-720-45	I	Inactivated by FDA		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 · 30 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	42546-720-45	`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	42546-720-45	`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	42546-720-45	`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	42546-720-45	`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	42546-720-45	`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	42546-720-45	`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	42546-720-45	`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	42546-720-45	`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	42546-720-45	`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	42546-720-45	`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	42546-720-45	`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	42546-720-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42546-720-45	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42546-720-45	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42546-720-45	`1332a3947898…`	`d4bfe170f9cd…`

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
A091314-001	ADAPALENE	ADAPALENE	0.1%	GEL / TOPICAL			2010-07-01

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 · 45 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	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091314-002	ADAPALENE	0.1%	GEL / TOPICAL		2019-07-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-07-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091314-002	ADAPALENE	0.1%	GEL / TOPICAL		2019-07-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-07-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091314-002	ADAPALENE	0.1%	GEL / TOPICAL		2019-07-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL	AB	2010-07-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`3bdfa0b2c4d7…`

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	A091314-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A091314-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091314-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091314-001	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42546-720-45	2023-01-30	C162847	48780-1	f386c64a-22ca-0266-e053-dadaa90a7c1a	Adapalene Gel, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42546-720-45	Adapalene	45 g in 1 TUBE	GEL	45		4
42546-720-45	Adapalene	1 in 1 CARTON	GEL	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42546-720-45	GM - Gram	42546-720	2f027944-5c44-467f-a8d0-051934396594	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42546-720	ADAPALENE GEL [PRUGEN, INC.]	4	Legacy NDC, 2 package rows	20180125_b85b6d8c-afbc-4ce1-9f77-e2579bf72c12.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adapalene	ADAPLANE 0.1%	Acne Free, LLC	0dc574e0-397a-7bc8-e063-6394a90a27e2	2026-07-31	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene Gel	ADAPLAENE	Acne Free LLC	0ce4684a-4733-e669-e063-6394a90a58c1	2026-07-31	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene	ADAPALENE	TOP CARE (Topco Associates LLC)	07351ab9-ed46-4ef8-85f3-bb6cc7af17c3	2026-05-19	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene	ADAPALENE	YYBA Corp	47d3a5f5-410c-288f-e063-6294a90a0d92	2026-02-03	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene	ADAPALENE	GLENMARK THERAPEUTICS INC., USA	42c1c354-2c00-4bc2-bbd3-a5dd5ff9a208	2026-01-31	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene	ADAPALENE	GLENMARK THERAPEUTICS INC., USA	ec6811f7-4728-41b1-8647-d63bb135e24e	2026-01-31	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Curist Acne Relief	ADAPALENE	Little Pharma, Inc.	e6380880-5299-0826-e053-2a95a90a1942	2026-01-11	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Effaclar	ADAPALENE	LOreal USA Products Inc	e94854c5-6bb8-43db-b898-4d47a419d075	2025-12-23	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene	ADAPALENE	Walgreens	53087d52-3fef-4d28-b2ef-93470e3e19b5	2025-12-11	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene	ADAPALENE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	62fab99a-f91b-4f0f-9143-9c9bc69df759	2025-08-25	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene	ADAPALENE	CVS Pharmacy	7fb758ce-4f15-4130-8612-9113a764b5cd	2025-08-25	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene	ADAPALENE	MEIJER, INC.	74715ce7-351f-495b-8637-57d809815681	2023-07-10	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene	ADAPALENE	P & L Development, LLC	a57b4381-03ee-4b4d-b607-9e266f80f773	2022-12-12	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Adapalene	ADAPALENE	LOreal USA Products Inc	24e0fd2f-05dc-4ff4-838f-ee022a3a9c20	2019-11-25	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314
Effaclar	ADAPALENE	LOreal USA Products Inc	a47b204a-3815-4a2b-9a7d-2c2b65b837bb	2019-08-23	Warnings	Exact identifier application applno (ANDA): 091314 application number: ANDA091314

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42546-720-45	42546072045	1 TUBE in 1 CARTON (42546-720-45) > 45 g in 1 TUBE	1 tube	2016-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adapalene Gel, 0.1%	PruGen, Inc. \| GLENMARK PHARMACEUTICALS INC., USA	2018-01-24	HUMAN PRESCRIPTION DRUG LABEL	4