Home NDC 51672-4155 Adapalene
Product NDC 51672-4155
11-digit product format 516724155
Labeler code 51672
Product ID 51672-4155_9ad52567-50fc-4046-812b-7a3f01492444
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adapalene
Dosage form GEL
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application NDA020380
Marketing category NDA AUTHORIZED GENERIC
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 E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 51672-4155-6 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 51672-4155-6 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 51672-4155-6 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 51672-4155-6 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 51672-4155-6 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 51672-4155-6 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 51672-4155-6 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 51672-4155-6 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 51672-4155-6 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 51672-4155-6 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 51672-4155-6 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 51672-4155-6 557ba5c1ecfa…9c80585c8c6e…
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Adapalene ACTIVE INGREDIENT 1L4806J2QF ADAPALENE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 Adapalene ACTIVE MOIETY 1L4806J2QF ADAPALENE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 CARBOMER 940 INACTIVE INGREDIENT 4Q93RCW27E ADAPALENE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ADAPALENE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB ADAPALENE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ADAPALENE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 POLOXAMER 182 INACTIVE INGREDIENT JX0HIX6OAG ADAPALENE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ADAPALENE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ADAPALENE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R ADAPALENE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3
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.