Home NDC 0299-4910 Differin
Product NDC 0299-4910
11-digit product format 002994910
Labeler code 0299
Product ID 0299-4910_7d2ef345-753e-4f6c-bb76-15fae398a44d
Type HUMAN OTC DRUG
Nonproprietary name Adapalene
Dosage form GEL
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA020380
Marketing category NDA
Marketing start 2016-07-08
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 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 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 · 42 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 2026-08-18 06:07:40 2026-07 N020380-002 DIFFERIN 0.1% GEL / TOPICAL RLD, RS 2016-07-08 caaa826d4ba7…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…
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…
Additional Listing Data#
Finished product Yes
Brand name base Differin
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153183 Internal RxNorm lookup 307731 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-4910 DIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.] 10 Current NDC, Legacy NDC, 10 package rows 20221213_0739d631-171b-42a8-bd55-0022b8df2d8a.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0299-4910-00 00299491000 1 TUBE in 1 BLISTER PACK (0299-4910-00) / 2 g in 1 TUBE 1 tube 2016-07-08 0000-00-00 No No Current 0299-4910-10 00299491010 1 BOTTLE, PUMP in 1 CARTON (0299-4910-10) / 15 g in 1 BOTTLE, PUMP 2020-01-01 0000-00-00 No No Current 0299-4910-15 00299491015 1 TUBE in 1 CARTON (0299-4910-15) / 15 g in 1 TUBE 1 tube 2016-07-08 0000-00-00 No No Current 0299-4910-40 00299491040 1 BOTTLE, PUMP in 1 CARTON (0299-4910-40) / 45 g in 1 BOTTLE, PUMP 2020-01-01 0000-00-00 No No Current 0299-4910-45 00299491045 1 TUBE in 1 CARTON (0299-4910-45) / 45 g in 1 TUBE 1 tube 2016-07-08 0000-00-00 No No Current