ADAPALENE

Product NDC: 66993-884
11-digit product format: 669930884
Labeler code: 66993
Product ID: 66993-884_6c51995a-bb3a-4d56-b0bf-ca7d9415765d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ADAPALENE
Dosage form: GEL
Route: TOPICAL
Labeler: Prasco Laboratories
Application: NDA021753
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: ADAPALENE
Active strength: 3 mg/g
Pharmacologic classes: Retinoid [EPC],Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	66993-884		D	Discontinued by firm	2026-08-10
excluded package	package	66993-884	66993-884-45	D	Discontinued by firm	2026-08-10
excluded package	package	66993-884	66993-884-48	D	Discontinued by firm	2026-08-10

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66993-884-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66993-884-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66993-884-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66993-884-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66993-884-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66993-884-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66993-884-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66993-884-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66993-884-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66993-884-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66993-884-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66993-884-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66993-884-48	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66993-884-45	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66993-884-48	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66993-884-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66993-884-48	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66993-884-45	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66993-884-48	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66993-884-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66993-884-48	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66993-884-45	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66993-884-48	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66993-884-45	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N021753-001	DIFFERIN	ADAPALENE	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021753-001	AB

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021753-001	DIFFERIN	0.3%	GEL / TOPICAL	AB	RLD, RS	2007-06-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021753-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021753-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021753-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021753-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021753-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021753-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021753-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021753-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021753-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021753-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021753-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021753-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021753-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021753-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021753-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021753-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021753-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021753-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021753-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021753-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021753-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021753-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021753-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021753-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021753-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021753-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021753-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021753-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021753-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021753-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021753-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021753-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021753-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021753-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021753-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021753-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021753-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021753-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021753-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 170 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021753-001	7579377	2025-02-23	U-818			`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021753-001	7579377	2025-02-23	U-818			`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021753-001	7579377	2025-02-23	U-818			`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021753-001	7579377	2025-02-23	U-818			`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021753-001	7737181	2024-08-29		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021753-001	7579377	2025-02-23	U-818			`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021753-001	7737181	2024-08-29		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021753-001	7579377	2025-02-23	U-818			`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021753-001	7737181	2024-08-29		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021753-001	7579377	2025-02-23	U-818			`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021753-001	7737181	2024-08-29		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021753-001	7579377	2025-02-23	U-818			`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021753-001	7737181	2024-08-29		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021753-001	7579377	2025-02-23	U-818			`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021753-001	7737181	2024-08-29		Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021753-001	7579377	2025-02-23	U-818			`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021753-001	7737181	2024-08-29		Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021753-001	7579377	2025-02-23	U-818			`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021753-001	7737181	2024-08-29		Drug product		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021753-001	7579377	2025-02-23	U-818			`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021753-001	7737181	2024-08-29		Drug product		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021753-001	7579377	2025-02-23	U-818			`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	7834060	2023-03-12	U-1078		2010-11-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	7838558	2023-03-12		Drug product	2010-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	7868044	2023-03-12	U-1078		2011-01-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	8703820	2023-03-12	U-1078		2014-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	7737181	2024-08-29		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021753-001	7579377	2025-02-23	U-818			`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021753-001	7834060	2023-03-12	U-1078		2010-11-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021753-001	7838558	2023-03-12		Drug product	2010-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021753-001	7868044	2023-03-12	U-1078		2011-01-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021753-001	8703820	2023-03-12	U-1078		2014-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021753-001	7737181	2024-08-29		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021753-001	7579377	2025-02-23	U-818			`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021753-001	7834060	2023-03-12	U-1078		2010-11-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021753-001	7838558	2023-03-12		Drug product	2010-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021753-001	7868044	2023-03-12	U-1078		2011-01-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021753-001	8703820	2023-03-12	U-1078		2014-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021753-001	7737181	2024-08-29		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021753-001	7579377	2025-02-23	U-818			`4b0b4de00fa7…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-884-45	GM - Gram	66993-884	3b9982bc-0f8c-46ca-89dd-c550436fc31c	1	2014-05-02
66993-884-48	GM - Gram	66993-884	7fbadf0b-1b77-4924-bc1f-c02e165a5df7	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Adapalene	ACTIVE INGREDIENT	1L4806J2QF	ADAPALENE GEL [PRASCO LABORATORIES]	1
ADAPALENE	ACTIVE MOIETY	1L4806J2QF	ADAPALENE GEL [PRASCO LABORATORIES]	1
Carbomer Homopolymer Type C	INACTIVE INGREDIENT	4Q93RCW27E	ADAPALENE GEL [PRASCO LABORATORIES]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	ADAPALENE GEL [PRASCO LABORATORIES]	1
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	ADAPALENE GEL [PRASCO LABORATORIES]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	ADAPALENE GEL [PRASCO LABORATORIES]	1
Poloxamer 124	INACTIVE INGREDIENT	1S66E28KXA	ADAPALENE GEL [PRASCO LABORATORIES]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	ADAPALENE GEL [PRASCO LABORATORIES]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	ADAPALENE GEL [PRASCO LABORATORIES]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	ADAPALENE GEL [PRASCO LABORATORIES]	1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIFFERIN	ADAPALENE	Galderma Laboratories, L.P.	a0031324-92a6-4c11-90e2-c2818f7278ec	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021753 application number: NDA021753
ADAPALENE	ADAPALENE	Mayne Pharma Commercial LLC.	9a0d9a0d-a9f3-4eb9-be76-166ef182d13a	2022-11-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021753 application number: NDA021753

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
66993-884-45	66993088445	1 TUBE in 1 CARTON (66993-884-45) > 45 g in 1 TUBE	1 tube	2014-04-08	0000-00-00	No	No	Current
66993-884-48	66993088448	1 BOTTLE, PUMP in 1 CARTON (66993-884-48) > 45 g in 1 BOTTLE, PUMP		2014-04-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ADAPALENE	Prasco Laboratories \| Galderma Laboratories, L.P. \| G Production Inc.	2018-02-22	HUMAN PRESCRIPTION DRUG LABEL	3