Home NDC 0316-0284-15 PanOxyl
Product NDC 0316-0284
Requested package NDC 0316-0284-15
11-digit product format 003160284
Labeler code 0316
Product ID 0316-0284_3bdcb3d7-164d-e678-e063-6394a90a3d6b
Type HUMAN OTC DRUG
Nonproprietary name Adapalene
Dosage form GEL
Route TOPICAL
Labeler CROWN LABORATORIES
Application ANDA215940
Marketing category ANDA
Marketing start 2025-08-08
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 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 · 12 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PanOxyl
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 · 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 0316-0284-15 PanOxyl 15 g in 1 TUBE GEL 15 1 0316-0284-15 PanOxyl 1 in 1 CARTON GEL 1 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0316-0284-15 00316028415 1 TUBE in 1 CARTON (0316-0284-15) / 15 g in 1 TUBE 1 tube 2025-08-08 No No Current