DIFFERIN

Product NDC: 0299-5910
11-digit product format: 002995910
Labeler code: 0299
Product ID: 0299-5910_79d4f186-a6fc-4fe5-9ca6-246c32317efd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: adapalene
Dosage form: GEL
Route: TOPICAL
Labeler: Galderma Laboratories, L.P.
Application: NDA020380
Marketing category: NDA
Marketing start: 1996-05-31
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: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0299-5910		D	Discontinued by firm		2026-08-10
excluded package	package	0299-5910	0299-5910-45	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 · 24 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	0299-5910-45	`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	0299-5910-45	`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	0299-5910-45	`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	0299-5910-45	`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	0299-5910-45	`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	0299-5910-45	`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	0299-5910-45	`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	0299-5910-45	`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	0299-5910-45	`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	0299-5910-45	`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	0299-5910-45	`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	0299-5910-45	`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
N020380-002	DIFFERIN	ADAPALENE	0.1%	GEL / TOPICAL		RLD, RS	2016-07-08

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020380-002	RTO	2019-07-08	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020380-002	RTO	2019-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020380-002	RTO	2019-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020380-002	RTO	2019-07-08	`ea99ee380514…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0299-5910-45	GM - Gram	0299-5910	8007b5fa-60c6-410d-af6a-5a43533254be	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
adapalene	ACTIVE INGREDIENT	1L4806J2QF	DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]	2
adapalene	ACTIVE MOIETY	1L4806J2QF	DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]	2
Carbomer Homopolymer Type C	INACTIVE INGREDIENT	4Q93RCW27E	DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]	2
Edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]	2
Hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]	2
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]	2
Poloxamer 182	INACTIVE INGREDIENT	JX0HIX6OAG	DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]	2
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]	2

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Differin	ADAPALENE	Galderma Laboratories, L.P.	0739d631-171b-42a8-bd55-0022b8df2d8a	2022-12-07	Warnings	Exact identifier application applno (NDA): 020380 application number: NDA020380

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	e616d076-9e99-46ea-b69a-585867334142	2
153183	Differin 0.1 % Topical Gel	PSN	e616d076-9e99-46ea-b69a-585867334142	2
153183	adapalene 0.001 MG/MG Topical Gel [Differin]	SBD	e616d076-9e99-46ea-b69a-585867334142	2
307731	adapalene 0.001 MG/MG Topical Gel	SCD	e616d076-9e99-46ea-b69a-585867334142	2
307731	adapalene 0.1 % Topical Gel	SY	e616d076-9e99-46ea-b69a-585867334142	2
153183	Differin 0.001 MG/MG Topical Gel	SY	e616d076-9e99-46ea-b69a-585867334142	2
153183	Differin 0.1 % Topical Gel	SY	e616d076-9e99-46ea-b69a-585867334142	2
153183	Differin 1 MG per GM Topical Gel	SY	e616d076-9e99-46ea-b69a-585867334142	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIFFERIN ® (adapalene gel) Gel, 0.1% Rx Only	Physicians Total Care, Inc.	2012-03-07	HUMAN PRESCRIPTION DRUG LABEL	2