docosanol

Generic: docosanol

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docosanol
Generic Name docosanol
Labeler cosette pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

docosanol 100 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0353
Product ID 0713-0353_e4d903b2-6585-4e80-a58e-128fe69cf1d4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215839
Listing Expiration 2026-12-31
Marketing Start 2024-01-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130353
Hyphenated Format 0713-0353

Supplemental Identifiers

RxCUI
797534
UPC
0307130353021
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 CARTON (0713-0353-02) / 2 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 CARTON (0713-0353-62) / 2 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

0713-0353-02 1 TUBE in 1 CARTON (0713-0353-02) / 2 g in 1 TUBE 0713-0353-62 1 BOTTLE, PUMP in 1 CARTON (0713-0353-62) / 2 g in 1 BOTTLE, PUMP

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": "e4d903b2-6585-4e80-a58e-128fe69cf1d4", "openfda": {"upc": ["0307130353021"], "unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["ccbb5e6d-cb85-449c-a480-28225d744f4d"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0353-02)  / 2 g in 1 TUBE", "package_ndc": "0713-0353-02", "marketing_start_date": "20240104"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0713-0353-62)  / 2 g in 1 BOTTLE, PUMP", "package_ndc": "0713-0353-62", "marketing_start_date": "20240104"}], "brand_name": "DOCOSANOL", "product_id": "0713-0353_e4d903b2-6585-4e80-a58e-128fe69cf1d4", "dosage_form": "CREAM", "product_ndc": "0713-0353", "generic_name": "Docosanol", "labeler_name": "Cosette Pharmaceuticals, Inc.", "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": "20240104", "listing_expiration_date": "20261231"}