panoxyl

Generic: adapalene

Labeler: crown laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name panoxyl
Generic Name adapalene
Labeler crown laboratories
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 1 mg/g

Manufacturer
CROWN LABORATORIES

Identifiers & Regulatory

Product NDC 0316-0284
Product ID 0316-0284_3bdcb3d7-164d-e678-e063-6394a90a3d6b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215940
Listing Expiration 2026-12-31
Marketing Start 2025-08-08

Pharmacologic Class

Established (EPC)
retinoid [epc]
Chemical Structure
retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03160284
Hyphenated Format 0316-0284

Supplemental Identifiers

RxCUI
307731
UPC
0303160284151
UNII
1L4806J2QF
NUI
N0000175607 M0018962

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name panoxyl (source: ndc)
Generic Name adapalene (source: ndc)
Application Number ANDA215940 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0316-0284-15) / 15 g in 1 TUBE
source: ndc

Packages (1)

0316-0284-15 1 TUBE in 1 CARTON (0316-0284-15) / 15 g in 1 TUBE

Ingredients (1)

adapalene (1 mg/g)

Linked Drug Pages (1)

PanOxyl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3bdcb3d7-164d-e678-e063-6394a90a3d6b", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0303160284151"], "unii": ["1L4806J2QF"], "rxcui": ["307731"], "spl_set_id": ["3bdcb3d7-164e-e678-e063-6394a90a3d6b"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["CROWN LABORATORIES"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0316-0284-15)  / 15 g in 1 TUBE", "package_ndc": "0316-0284-15", "marketing_start_date": "20250808"}], "brand_name": "PanOxyl", "product_id": "0316-0284_3bdcb3d7-164d-e678-e063-6394a90a3d6b", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0316-0284", "generic_name": "Adapalene", "labeler_name": "CROWN LABORATORIES", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PanOxyl", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/g"}], "application_number": "ANDA215940", "marketing_category": "ANDA", "marketing_start_date": "20250808", "listing_expiration_date": "20261231"}