cold sore treatment

Generic: docosanol

Labeler: p & l development, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cold sore treatment
Generic Name docosanol
Labeler p & l development, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

docosanol 100 mg/g

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 59726-922
Product ID 59726-922_661f138d-c81b-4eb5-b919-25c09e6d1bf8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212385
Listing Expiration 2026-12-31
Marketing Start 2023-07-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59726922
Hyphenated Format 59726-922

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 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 BOTTLE, PUMP (59726-922-07) / 2 g in 1 TUBE
  • 2 TUBE in 1 PACKAGE (59726-922-14) / 2 g in 1 TUBE
source: ndc

Packages (2)

59726-922-07 1 TUBE in 1 BOTTLE, PUMP (59726-922-07) / 2 g in 1 TUBE 59726-922-14 2 TUBE in 1 PACKAGE (59726-922-14) / 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": "661f138d-c81b-4eb5-b919-25c09e6d1bf8", "openfda": {"unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["20d2480b-44b5-499f-8670-01d6a4e4cb34"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOTTLE, PUMP (59726-922-07)  / 2 g in 1 TUBE", "package_ndc": "59726-922-07", "marketing_start_date": "20230715"}, {"sample": false, "description": "2 TUBE in 1 PACKAGE (59726-922-14)  / 2 g in 1 TUBE", "package_ndc": "59726-922-14", "marketing_start_date": "20230715"}], "brand_name": "Cold Sore Treatment", "product_id": "59726-922_661f138d-c81b-4eb5-b919-25c09e6d1bf8", "dosage_form": "CREAM", "product_ndc": "59726-922", "generic_name": "Docosanol", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold Sore Treatment", "active_ingredients": [{"name": "DOCOSANOL", "strength": "100 mg/g"}], "application_number": "ANDA212385", "marketing_category": "ANDA", "marketing_start_date": "20230715", "listing_expiration_date": "20261231"}