Adapalene Paraben Free

Product NDC: 79481-2210
11-digit product format: 794812210
Labeler code: 79481
Product ID: 79481-2210_d1eebb90-aeea-4a70-8268-5babfcaaef7e
Type: HUMAN OTC DRUG
Nonproprietary name: Adapalene
Dosage form: GEL
Route: TOPICAL
Labeler: Meijer Distribution Inc.
Application: ANDA090962
Marketing category: ANDA
Marketing start: 2026-09-15
Substance: ADAPALENE
Active strength: 1 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
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 · 43 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	A090962-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-06-02	`84e616aacf4f…`
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…`

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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Adapalene Paraben Free
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ADAPALENE	1 mg/g

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	Walgreens	2c1cdc03-087d-43b0-b0b3-503a35398a53	2026-08-21	Warnings	Exact identifier application applno (ANDA): 090962 application number: ANDA090962
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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
79481-2210-5	79481221005	1 TUBE in 1 CARTON (79481-2210-5) / 15 g in 1 TUBE	1 tube	2026-09-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adapalene Gel USP 0 1 percent Paraben Free 0 5 oz ENE	Meijer Distribution Inc.	2026-09-15	HUMAN OTC DRUG LABEL	5