Neutrogena Adapalene 0.1% Acne Treatment

Product NDC: 69968-0826
Requested package NDC: 69968-0826-1
11-digit product format: 699680826
Labeler code: 69968
Product ID: 69968-0826_21bf71d1-8aea-5bec-e063-6294a90aed2c
Type: HUMAN OTC DRUG
Nonproprietary name: Adapalene
Dosage form: GEL
Route: TOPICAL
Labeler: Kenvue Brands LLC
Application: ANDA090962
Marketing category: ANDA
Marketing start: 2023-12-04
Substance: ADAPALENE
Active strength: 1 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 69968-0826-1 ndc (product): 69968-0826 ndc11 (package): 69968082601
Adapalene	ADAPALENE	CVS PHARMACY, INC	ff9a929e-121b-42b4-8e79-f8f46c22a8be	2024-02-21	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962

Additional Listing Data#

Finished product: Yes
Brand name base: Neutrogena Adapalene 0.1% Acne Treatment
Listing expiration: 2026-12-31

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
0682cb55-6ae3-437f-e063-6294a90ac510	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
69968-0826-1	Neutrogena Adapalene 0.1% Acne Treatment	1 in 1 CARTON	GEL	1		2
69968-0826-1	Neutrogena Adapalene 0.1% Acne Treatment	45 g in 1 TUBE	GEL	45		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0826	NEUTROGENA ADAPALENE 0.1% ACNE TREATMENT (ADAPALENE) GEL [KENVUE BRANDS LLC]	2	Current NDC, 2 package rows	20241115_0682cb55-6ae3-437f-e063-6294a90ac510.zip

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	0682cb55-6ae3-437f-e063-6294a90ac510	2
307731	adapalene 0.001 MG/MG Topical Gel	SCD	0682cb55-6ae3-437f-e063-6294a90ac510	2
307731	adapalene 0.1 % Topical Gel	SY	0682cb55-6ae3-437f-e063-6294a90ac510	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69968-0826-1	69968082601	1 TUBE in 1 CARTON (69968-0826-1) / 45 g in 1 TUBE	1 tube	2023-12-04	No	No	Current