cold sore fever blister 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 fever blister 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 81522-112
Product ID 81522-112_788e64c2-c330-4488-aa87-35fdd7fed014
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212385
Marketing Start 2023-12-31
Marketing End 2027-08-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81522112
Hyphenated Format 81522-112

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 cold sore fever blister treatment (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
  • 1 TUBE in 1 PACKAGE (81522-112-07) / 2 g in 1 TUBE
source: ndc

Packages (1)

81522-112-07 1 TUBE in 1 PACKAGE (81522-112-07) / 2 g in 1 TUBE

Ingredients (1)

docosanol (100 mg/g)

Linked Drug Pages (1)

Cold Sore Fever Blister Treatment ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "788e64c2-c330-4488-aa87-35fdd7fed014", "openfda": {"unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["fe67f56e-4c35-40cb-8a75-174a873f2900"], "manufacturer_name": ["FSA Store Inc. (Caring Mills)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (81522-112-07)  / 2 g in 1 TUBE", "package_ndc": "81522-112-07", "marketing_end_date": "20270828", "marketing_start_date": "20231231"}], "brand_name": "Cold Sore Fever Blister Treatment", "product_id": "81522-112_788e64c2-c330-4488-aa87-35fdd7fed014", "dosage_form": "CREAM", "product_ndc": "81522-112", "generic_name": "Docosanol", "labeler_name": "FSA Store Inc. (Caring Mills)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold Sore Fever Blister Treatment", "active_ingredients": [{"name": "DOCOSANOL", "strength": "100 mg/g"}], "application_number": "ANDA212385", "marketing_category": "ANDA", "marketing_end_date": "20270828", "marketing_start_date": "20231231"}