cold sore fever blister treatment

Generic: docosanol

Labeler: topco associates
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cold sore fever blister treatment
Generic Name docosanol
Labeler topco associates
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

docosanol 100 mg/g

Manufacturer
Topco Associates

Identifiers & Regulatory

Product NDC 76162-818
Product ID 76162-818_12928119-fbf0-4732-9e4f-b77ab18304eb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212385
Marketing Start 2023-12-31
Marketing End 2028-06-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162818
Hyphenated Format 76162-818

Supplemental Identifiers

RxCUI
797534
UPC
0036800496415
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 (76162-818-07) / 2 g in 1 TUBE
source: ndc

Packages (1)

76162-818-07 1 TUBE in 1 PACKAGE (76162-818-07) / 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": "12928119-fbf0-4732-9e4f-b77ab18304eb", "openfda": {"upc": ["0036800496415"], "unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["73348ce7-5b08-49ad-ba59-6f54887f819b"], "manufacturer_name": ["Topco Associates"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (76162-818-07)  / 2 g in 1 TUBE", "package_ndc": "76162-818-07", "marketing_end_date": "20280630", "marketing_start_date": "20231231"}], "brand_name": "Cold Sore Fever Blister Treatment", "product_id": "76162-818_12928119-fbf0-4732-9e4f-b77ab18304eb", "dosage_form": "CREAM", "product_ndc": "76162-818", "generic_name": "Docosanol", "labeler_name": "Topco Associates", "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": "20280630", "marketing_start_date": "20231231"}