Home NDC 82034-888 Adapalene
Product NDC 82034-888
11-digit product format 820340888
Labeler code 82034
Product ID 82034-888_f6c2a212-8b9b-4793-b25f-9cdcc5cfecb5
Type HUMAN OTC DRUG
Nonproprietary name Adapalene
Dosage form GEL
Route TOPICAL
Labeler Stryke Club, Inc.
Application ANDA091314
Marketing category ANDA
Marketing start 2021-11-12
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 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 82034-888 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 82034-888 82034-888-05 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product 82034-888 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 82034-888 82034-888-05 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 82034-888 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 82034-888 82034-888-05 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product 82034-888 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 82034-888 82034-888-05 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product 82034-888 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 82034-888 82034-888-05 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product 82034-888 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 82034-888 82034-888-05 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 82034-888 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 82034-888 82034-888-05 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 82034-888 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 82034-888 82034-888-05 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 82034-888 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 82034-888 82034-888-05 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 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 · 44 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 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…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091314-001 ADAPALENE 0.1% GEL / TOPICAL 2010-07-01 3a93d1ddd44b…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82034-888-05 82034088805 1 TUBE in 1 CARTON (82034-888-05) > 15 g in 1 TUBE 1 tube 2021-11-12 0000-00-00 No No Current