Adapalene

Product NDC: 36800-088
Requested package NDC: 36800-088-05
11-digit product format: 368000088
Labeler code: 36800
Product ID: 36800-088_eaf6cd8c-63b5-42e9-aeaa-e911c19b9e4c
Type: HUMAN OTC DRUG
Nonproprietary name: Adapalene
Dosage form: GEL
Route: TOPICAL
Labeler: TOP CARE (Topco Associates LLC)
Application: ANDA091314
Marketing category: ANDA
Marketing start: 2020-07-30
Marketing end: 0000-00-00
Substance: ADAPALENE
Active strength: 1 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-088	36800-088-05	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 46 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
2026-09-14 22:38:34	2026-08	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`84e616aacf4f…`
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…`

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-088-05	Adapalene	15 g in 1 TUBE	GEL	15		3
36800-088-05	Adapalene	1 in 1 CARTON	GEL	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-088	ADAPALENE GEL [TOP CARE (TOPCO ASSOCIATES LLC)]	2	Legacy NDC, 2 package rows	20221129_07351ab9-ed46-4ef8-85f3-bb6cc7af17c3.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 · 14 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 ndc (package): 36800-088-05 ndc (product): 36800-088 ndc11 (package): 36800008805
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	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307731	adapalene 0.1 % Topical Gel	PSN	07351ab9-ed46-4ef8-85f3-bb6cc7af17c3	3
307731	adapalene 0.001 MG/MG Topical Gel	SCD	07351ab9-ed46-4ef8-85f3-bb6cc7af17c3	3
307731	adapalene 0.1 % Topical Gel	SY	07351ab9-ed46-4ef8-85f3-bb6cc7af17c3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-088-05	36800008805	1 TUBE in 1 CARTON (36800-088-05) > 15 g in 1 TUBE	1 tube	2020-07-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adapalene Gel USP 0 1 percent DELISTED	TOP CARE (Topco Associates LLC)	2026-05-19	HUMAN OTC DRUG LABEL	3