adapalene gel

Generic: adaplaene

Labeler: acne free llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene gel
Generic Name adaplaene
Labeler acne free llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene .00036 g/g

Manufacturer
Acne Free LLC

Identifiers & Regulatory

Product NDC 80861-114
Product ID 80861-114_3aaef186-493c-bd80-e063-6394a90aa795
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091314
Listing Expiration 2026-12-31
Marketing Start 2023-12-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80861114
Hyphenated Format 80861-114

Supplemental Identifiers

UPC
0850004234563
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 adapalene gel (source: ndc)
Generic Name adaplaene (source: ndc)
Application Number ANDA091314 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .00036 g/g
source: ndc
Packaging
  • 1 g in 1 TUBE (80861-114-01)
source: ndc

Packages (1)

80861-114-01 1 g in 1 TUBE (80861-114-01)

Ingredients (1)

adapalene (.00036 g/g)

Linked Drug Pages (1)

Adapalene Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3aaef186-493c-bd80-e063-6394a90aa795", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0850004234563"], "unii": ["1L4806J2QF"], "spl_set_id": ["0ce4684a-4733-e669-e063-6394a90a58c1"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Acne Free LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 g in 1 TUBE (80861-114-01)", "package_ndc": "80861-114-01", "marketing_start_date": "20231220"}], "brand_name": "Adapalene Gel", "product_id": "80861-114_3aaef186-493c-bd80-e063-6394a90aa795", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "80861-114", "generic_name": "Adaplaene", "labeler_name": "Acne Free LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Adapalene Gel", "active_ingredients": [{"name": "ADAPALENE", "strength": ".00036 g/g"}], "application_number": "ANDA091314", "marketing_category": "ANDA", "marketing_start_date": "20231220", "listing_expiration_date": "20261231"}