Home NDC 11410-958 Proactiv MD Adapalene
Product NDC 11410-958
11-digit product format 114100958
Labeler code 11410
Product ID 11410-958_47d20188-59f7-d011-e063-6294a90a39fa
Type HUMAN OTC DRUG
Nonproprietary name Adapalene
Dosage form GEL
Route TOPICAL
Labeler Alchemee, LLC
Application ANDA215940
Marketing category ANDA
Marketing start 2023-11-16
Substance ADAPALENE
Active strength .1 g/100g
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A215940-001 ADAPALENE ADAPALENE 0.1% GEL / TOPICAL 2022-01-14
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.
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 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Proactiv MD Adapalene
Brand name suffix Acne Treatment
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ADAPALENE .1 g/100g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307731 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11410-958-15 Proactiv MD AdapaleneAcne Treatment 15 g in 1 TUBE GEL 15 5 11410-958-15 Proactiv MD AdapaleneAcne Treatment 1 in 1 BOX GEL 1 5 11410-958-45 Proactiv MD AdapaleneAcne Treatment 1 in 1 BOX GEL 1 5 11410-958-45 Proactiv MD AdapaleneAcne Treatment 45 g in 1 TUBE GEL 45 5 11410-958-15 Proactiv MD Kit 15 g in 1 TUBE GEL 15 g in 100 0.1 g in 100g 2 11410-958-15 Proactiv MD Kit 1 in 1 BOX GEL 0.1 g in 100g 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11410-958 PROACTIV MD ADAPALENE ACNE TREATMENT (ADAPALENE) GEL [ALCHEMEE, LLC] 3 Current NDC, 4 package rows 20250309_0a9b3755-c0db-4282-e063-6394a90a0c08.zip 11410-958 PROACTIV MD KIT (MD KIT) KIT [ALCHEMEE, LLC] 1 Current NDC 20240726_1d142dba-145c-fb33-e063-6394a90a88b6.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 · 12 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11410-958-15 11410095815 1 TUBE in 1 BOX (11410-958-15) / 15 g in 1 TUBE 1 tube 2023-11-16 No No Current 11410-958-45 11410095845 1 TUBE in 1 BOX (11410-958-45) / 45 g in 1 TUBE 1 tube 2023-11-16 No No Current