cold sore treatment

Generic: docosanol

Labeler: fsa store inc. (caring mills)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cold sore treatment
Generic Name docosanol
Labeler fsa store inc. (caring mills)
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

docosanol 100 mg/g

Manufacturer
FSA Store Inc. (Caring Mills)

Identifiers & Regulatory

Product NDC 81522-922
Product ID 81522-922_7f6cfb0e-6357-4328-8fb3-25e99a0f9e85
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208754
Listing Expiration 2026-12-31
Marketing Start 2021-10-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81522922
Hyphenated Format 81522-922

Supplemental Identifiers

RxCUI
797534
UPC
0359726922104
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 cold sore treatment (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 (81522-922-07) / 2 g in 1 TUBE
source: ndc

Packages (1)

81522-922-07 1 TUBE in 1 PACKAGE (81522-922-07) / 2 g in 1 TUBE

Ingredients (1)

docosanol (100 mg/g)

Linked Drug Pages (1)

Cold Sore Treatment ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7f6cfb0e-6357-4328-8fb3-25e99a0f9e85", "openfda": {"upc": ["0359726922104"], "unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["a46e4d60-e84b-44a9-9d54-4861dbe91c59"], "manufacturer_name": ["FSA Store Inc. (Caring Mills)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (81522-922-07)  / 2 g in 1 TUBE", "package_ndc": "81522-922-07", "marketing_start_date": "20211008"}], "brand_name": "Cold Sore Treatment", "product_id": "81522-922_7f6cfb0e-6357-4328-8fb3-25e99a0f9e85", "dosage_form": "CREAM", "product_ndc": "81522-922", "generic_name": "Docosanol", "labeler_name": "FSA Store Inc. (Caring Mills)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold Sore Treatment", "active_ingredients": [{"name": "DOCOSANOL", "strength": "100 mg/g"}], "application_number": "ANDA208754", "marketing_category": "ANDA", "marketing_start_date": "20211008", "listing_expiration_date": "20261231"}