Adapalene

Product NDC: 51672-2150
11-digit product format: 516722150
Labeler code: 51672
Product ID: 51672-2150_35328d05-d4b5-7aac-e063-6294a90a2f8b
Type: HUMAN OTC DRUG
Nonproprietary name: Adapalene
Dosage form: GEL
Route: TOPICAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA215940
Marketing category: ANDA
Marketing start: 2022-01-14
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

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	51672-2150		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51672-2150	51672-2150-1	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51672-2150	51672-2150-6	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A215940-001	ADAPALENE	ADAPALENE	0.1%	GEL / TOPICAL			2022-01-14

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215940-001	ADAPALENE	0.1%	GEL / TOPICAL	2022-01-14	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Adapalene
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
a9ca1f7a-71c3-4814-9366-e7e5760bf32c	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	SPL version
51672-2150-1	Adapalene	15 g in 1 TUBE	GEL	15	6
51672-2150-1	Adapalene	1 in 1 CARTON	GEL	1	6
51672-2150-6	Adapalene	45 g in 1 TUBE	GEL	45	6
51672-2150-6	Adapalene	1 in 1 CARTON	GEL	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2150-1	GM - Gram	51672-2150	e9853787-d745-44a1-b2ef-bc2815b9adac	1	2025-08-11
51672-2150-6	GM - Gram	51672-2150	3434f184-cd91-4079-8317-ac182a102054	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-2150	ADAPALENE GEL [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Current NDC, 4 package rows	20250521_a9ca1f7a-71c3-4814-9366-e7e5760bf32c.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	RUGBY LABORATORIES, INC.	330bc2b3-e064-4189-9c47-9c5a50aa4dde	2026-06-01	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
Proactiv MD Adapalene Acne Treatment	ADAPALENE	Alchemee, LLC	0a9b3755-c0db-4282-e063-6394a90a0c08	2026-01-07	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
Adapalene	ADAPALENE	Wal-Mart Stores Inc	36eb4a78-3a7e-b39f-e063-6394a90ad159	2025-12-16	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
ADAPALENE	ADAPALENE	Target Corporation	164f52fa-3050-3eea-e063-6394a90a6f70	2025-09-08	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
PanOxyl	ADAPALENE	CROWN LABORATORIES	3bdcb3d7-164e-e678-e063-6394a90a3d6b	2025-08-08	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
Adapalene	ADAPALENE	AMERISOURCE BERGEN	8d6e2e28-a11a-4443-a43b-098a55622e24	2025-07-02	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
ADAPALENE	ADAPALENE	Cardinal Health	d894d7ce-4c44-4092-88dd-8e8f7ef777f2	2025-07-02	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
ADAPALENE	ADAPALENE	RITE AID	0c96c096-73f8-5bc2-e063-6294a90a235f	2025-07-02	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
Adapalene	ADAPALENE	YYBA Corp	2d7f95d1-2f9a-1623-e063-6294a90a6724	2025-07-02	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
PanOxyl	ADAPALENE	CROWN LABORATORIES	40f8d9e1-d1b9-464b-92ba-9695d419a6f7	2025-07-02	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
Adapalene	ADAPALENE	YYBA CORP	3ab5661b-a67a-45a3-b542-228be3cebb27	2025-07-02	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940
Adapalene	ADAPALENE	Sun Pharmaceutical Industries, Inc.	a9ca1f7a-71c3-4814-9366-e7e5760bf32c	2025-05-15	Warnings	Exact identifier application applno (ANDA): 215940 application number: ANDA215940 ndc (product): 51672-2150

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	a9ca1f7a-71c3-4814-9366-e7e5760bf32c	6
307731	adapalene 0.001 MG/MG Topical Gel	SCD	a9ca1f7a-71c3-4814-9366-e7e5760bf32c	6
307731	adapalene 0.1 % Topical Gel	SY	a9ca1f7a-71c3-4814-9366-e7e5760bf32c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51672-2150-1	51672215001	1 TUBE in 1 CARTON (51672-2150-1) / 15 g in 1 TUBE	1 tube	2022-01-14	No	No	Current
51672-2150-6	51672215006	1 TUBE in 1 CARTON (51672-2150-6) / 45 g in 1 TUBE	1 tube	2022-01-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adapalene Gel USP, 0.1%	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-05-15	HUMAN OTC DRUG LABEL	6