abreva

Generic: docosanol

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name abreva
Generic Name docosanol
Labeler haleon us holdings llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

docosanol 100 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0300
Product ID 0135-0300_1b529b4c-e36d-5070-e063-6294a90ac5c8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208754
Listing Expiration 2026-12-31
Marketing Start 2022-03-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350300
Hyphenated Format 0135-0300

Supplemental Identifiers

RxCUI
797534 855205
UNII
9G1OE216XY

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 abreva (source: ndc)
Generic Name docosanol (source: ndc)
Application Number ANDA208754 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 PACKAGE (0135-0300-01) / 2 g in 1 TUBE
  • 2 TUBE in 1 PACKAGE (0135-0300-02) / 2 g in 1 TUBE
source: ndc

Packages (2)

0135-0300-01 1 TUBE in 1 PACKAGE (0135-0300-01) / 2 g in 1 TUBE 0135-0300-02 2 TUBE in 1 PACKAGE (0135-0300-02) / 2 g in 1 TUBE

Ingredients (1)

docosanol (100 mg/g)

Linked Drug Pages (1)

ABREVA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1b529b4c-e36d-5070-e063-6294a90ac5c8", "openfda": {"unii": ["9G1OE216XY"], "rxcui": ["797534", "855205"], "spl_set_id": ["bf02c8c5-af60-41f1-a202-38a97491a720"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (0135-0300-01)  / 2 g in 1 TUBE", "package_ndc": "0135-0300-01", "marketing_start_date": "20220325"}, {"sample": false, "description": "2 TUBE in 1 PACKAGE (0135-0300-02)  / 2 g in 1 TUBE", "package_ndc": "0135-0300-02", "marketing_start_date": "20220425"}], "brand_name": "ABREVA", "product_id": "0135-0300_1b529b4c-e36d-5070-e063-6294a90ac5c8", "dosage_form": "CREAM", "product_ndc": "0135-0300", "generic_name": "docosanol", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ABREVA", "active_ingredients": [{"name": "DOCOSANOL", "strength": "100 mg/g"}], "application_number": "ANDA208754", "marketing_category": "ANDA", "marketing_start_date": "20220325", "listing_expiration_date": "20261231"}