docosanol

Generic: docosanol

Labeler: cvs pharmacy, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docosanol
Generic Name docosanol
Labeler cvs pharmacy, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

docosanol 100 mg/g

Manufacturer
CVS Pharmacy, Inc.

Identifiers & Regulatory

Product NDC 51316-763
Product ID 51316-763_b341e5b5-f52a-487d-a7e4-dc158dba1f9b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215839
Listing Expiration 2026-12-31
Marketing Start 2024-05-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316763
Hyphenated Format 51316-763

Supplemental Identifiers

RxCUI
797534
UPC
0050428495230 0050428087411 0050428489703 0050428515549 0050428087435
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 (51316-763-02) / 2 g in 1 TUBE
  • 2 TUBE in 1 PACKAGE (51316-763-03) / 2 g in 1 TUBE
  • 1 TUBE in 1 PACKAGE (51316-763-04) / 2 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 PACKAGE (51316-763-62) / 2 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 PACKAGE (51316-763-64) / 2 g in 1 BOTTLE, PUMP
source: ndc

Packages (5)

51316-763-02 1 TUBE in 1 PACKAGE (51316-763-02) / 2 g in 1 TUBE 51316-763-03 2 TUBE in 1 PACKAGE (51316-763-03) / 2 g in 1 TUBE 51316-763-04 1 TUBE in 1 PACKAGE (51316-763-04) / 2 g in 1 TUBE 51316-763-62 1 BOTTLE, PUMP in 1 PACKAGE (51316-763-62) / 2 g in 1 BOTTLE, PUMP 51316-763-64 1 BOTTLE, PUMP in 1 PACKAGE (51316-763-64) / 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": "b341e5b5-f52a-487d-a7e4-dc158dba1f9b", "openfda": {"upc": ["0050428495230", "0050428087411", "0050428489703", "0050428515549", "0050428087435"], "unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b"], "manufacturer_name": ["CVS Pharmacy, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (51316-763-02)  / 2 g in 1 TUBE", "package_ndc": "51316-763-02", "marketing_start_date": "20240523"}, {"sample": false, "description": "2 TUBE in 1 PACKAGE (51316-763-03)  / 2 g in 1 TUBE", "package_ndc": "51316-763-03", "marketing_start_date": "20240523"}, {"sample": false, "description": "1 TUBE in 1 PACKAGE (51316-763-04)  / 2 g in 1 TUBE", "package_ndc": "51316-763-04", "marketing_start_date": "20240523"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 PACKAGE (51316-763-62)  / 2 g in 1 BOTTLE, PUMP", "package_ndc": "51316-763-62", "marketing_start_date": "20240523"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 PACKAGE (51316-763-64)  / 2 g in 1 BOTTLE, PUMP", "package_ndc": "51316-763-64", "marketing_start_date": "20240523"}], "brand_name": "DOCOSANOL", "product_id": "51316-763_b341e5b5-f52a-487d-a7e4-dc158dba1f9b", "dosage_form": "CREAM", "product_ndc": "51316-763", "generic_name": "DOCOSANOL", "labeler_name": "CVS Pharmacy, 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": "20240523", "listing_expiration_date": "20261231"}