Adapalene

Product NDC: 59726-114
11-digit product format: 597260114
Labeler code: 59726
Product ID: 59726-114_1475ee8f-99c8-4bfb-b17f-008a11672860
Type: HUMAN OTC DRUG
Nonproprietary name: Adapalene
Dosage form: GEL
Route: TOPICAL
Labeler: P & L Development, LLC
Application: ANDA090962
Marketing category: ANDA
Marketing start: 2023-11-30
Marketing end: 2027-03-30
Substance: ADAPALENE
Active strength: 1 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Current FDA listing: Yes

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
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 · 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`cb3db0bc1861…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Adapalene

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ADAPALENE	1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1L4806J2QF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307731	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e9155950-6c92-4f57-851a-51be6ba9062f	Available on FDA.report

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
59726-114-05	Adapalene	1 in 1 CARTON	GEL	1		3
59726-114-05	Adapalene	15 g in 1 TUBE	GEL	15		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59726-114	ADAPALENE GEL [P & L DEVELOPMENT, LLC]	2	Current NDC, 2 package rows	20240223_e9155950-6c92-4f57-851a-51be6ba9062f.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 · 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 ndc (product): 59726-114
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	e9155950-6c92-4f57-851a-51be6ba9062f	3
307731	adapalene 0.001 MG/MG Topical Gel	SCD	e9155950-6c92-4f57-851a-51be6ba9062f	3
307731	adapalene 0.1 % Topical Gel	SY	e9155950-6c92-4f57-851a-51be6ba9062f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59726-114-05	59726011405	1 TUBE in 1 CARTON (59726-114-05) / 15 g in 1 TUBE	1 tube	2023-11-30	2027-03-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adapalene Gel USP 0 1 percent ENE 0 5 OZ DELISTED	P & L Development, LLC	2025-12-16	HUMAN OTC DRUG LABEL	3