docosanol

Generic: docosanol

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

Drug Facts

Product Profile

Brand Name docosanol
Generic Name docosanol
Labeler rugby laboratories
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

docosanol 100 mg/g

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1427
Product ID 0536-1427_9b89030f-1b9a-4519-96d0-5e40b9e1debd
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215839
Listing Expiration 2026-12-31
Marketing Start 2024-05-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05361427
Hyphenated Format 0536-1427

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 ANDA215839 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 PACKAGE (0536-1427-04) / 2 g in 1 TUBE
source: ndc

Packages (1)

0536-1427-04 1 TUBE in 1 PACKAGE (0536-1427-04) / 2 g in 1 TUBE

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": "9b89030f-1b9a-4519-96d0-5e40b9e1debd", "openfda": {"unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["6f8d6375-8188-42e9-a048-e8a554122ff3"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (0536-1427-04)  / 2 g in 1 TUBE", "package_ndc": "0536-1427-04", "marketing_start_date": "20240522"}], "brand_name": "DOCOSANOL", "product_id": "0536-1427_9b89030f-1b9a-4519-96d0-5e40b9e1debd", "dosage_form": "CREAM", "product_ndc": "0536-1427", "generic_name": "Docosanol", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DOCOSANOL", "active_ingredients": [{"name": "DOCOSANOL", "strength": "100 mg/g"}], "application_number": "ANDA215839", "marketing_category": "ANDA", "marketing_start_date": "20240522", "listing_expiration_date": "20261231"}