docosanol

Generic: docosanol

Labeler: h2-pharma, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docosanol
Generic Name docosanol
Labeler h2-pharma, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

docosanol 100 mg/g

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-881
Product ID 61269-881_f2757843-0b78-46be-a22c-bcdf3a433464
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212385
Listing Expiration 2026-12-31
Marketing Start 2025-04-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269881
Hyphenated Format 61269-881

Supplemental Identifiers

RxCUI
797534
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 docosanol (source: ndc)
Generic Name docosanol (source: ndc)
Application Number ANDA212385 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/g
source: ndc
Packaging
  • 2 g in 1 TUBE (61269-881-35)
source: ndc

Packages (1)

61269-881-35 2 g in 1 TUBE (61269-881-35)

Ingredients (1)

docosanol (100 mg/g)

Linked Drug Pages (1)

DOCOSANOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "f2757843-0b78-46be-a22c-bcdf3a433464", "openfda": {"unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["f0b3a78b-b14c-4869-ba3b-d04ffa62e1d5"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 g in 1 TUBE (61269-881-35)", "package_ndc": "61269-881-35", "marketing_start_date": "20250410"}], "brand_name": "DOCOSANOL", "product_id": "61269-881_f2757843-0b78-46be-a22c-bcdf3a433464", "dosage_form": "CREAM", "product_ndc": "61269-881", "generic_name": "DOCOSANOL", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DOCOSANOL", "active_ingredients": [{"name": "DOCOSANOL", "strength": "100 mg/g"}], "application_number": "ANDA212385", "marketing_category": "ANDA", "marketing_start_date": "20250410", "listing_expiration_date": "20261231"}