Home NDC 11410-958-15 Proactiv MD Adapalene
Product NDC 11410-958
Requested package NDC 11410-958-15
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 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 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 2026-08-01 22:54:32 2026-06 A215940-001 ADAPALENE 0.1% GEL / TOPICAL 2022-01-14 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 13 matching rows.
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
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