Adapalene

Product NDC: 70000-0043
11-digit product format: 700000043
Labeler code: 70000
Product ID: 70000-0043_99da7230-9480-4b05-91c7-f8609f34ab01
Type: HUMAN OTC DRUG
Nonproprietary name: Adapalene
Dosage form: GEL
Route: TOPICAL
Labeler: Cardinal Health (Leader) 70000
Application: ANDA091314
Marketing category: ANDA
Marketing start: 2019-02-19
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70000-0043		D	Discontinued by firm	2026-08-17
excluded package	package	70000-0043	70000-0043-1	D	Discontinued by firm	2026-08-17
excluded package	package	70000-0043	70000-0043-2	D	Discontinued by firm	2026-08-17

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
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 · 45 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
2026-08-18 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…`
2023-01-26 05:58 UTC	2023-01	A091314-001	ADAPALENE	0.1%	GEL / TOPICAL		2010-07-01	`3bdfa0b2c4d7…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0043-1	GM - Gram	70000-0043	bebfe4d9-2425-4c2b-a795-726275bb1dc4	1	2020-08-06
70000-0043-2	GM - Gram	70000-0043	426b8072-4c93-4f95-a493-d2f9c2c40c4f	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0043	ADAPALENE GEL [CARDINAL HEALTH (LEADER) 70000]	3	Legacy NDC	20221108_9e9c882c-4c57-4bb1-b1eb-66cf52ebc848.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 · 15 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
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	P & L Development, LLC	a57b4381-03ee-4b4d-b607-9e266f80f773	2022-12-12	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0043-1	70000004301	1 TUBE in 1 CARTON (70000-0043-1) > 15 g in 1 TUBE	1 tube	2019-02-19	0000-00-00	No	No	Current
70000-0043-2	70000004302	1 TUBE in 1 CARTON (70000-0043-2) > 45 g in 1 TUBE	1 tube	2019-02-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adapalene Gel USP 01 percent DELISTED	Cardinal Health (Leader) 70000	2025-06-16	HUMAN OTC DRUG LABEL	4