docosanol

Generic: docosanol

Labeler: encube ethicals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docosanol
Generic Name docosanol
Labeler encube ethicals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

docosanol 100 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-023
Product ID 21922-023_a1fe87d9-27cf-4ff0-9e70-52b038882e36
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212385
Listing Expiration 2026-12-31
Marketing Start 2022-10-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922023
Hyphenated Format 21922-023

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 docosanol (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 BOTTLE, PUMP in 1 PACKAGE (21922-023-17) / 2 g in 1 BOTTLE, PUMP
  • 1 TUBE in 1 PACKAGE (21922-023-18) / 2 g in 1 TUBE
source: ndc

Packages (2)

21922-023-17 1 BOTTLE, PUMP in 1 PACKAGE (21922-023-17) / 2 g in 1 BOTTLE, PUMP 21922-023-18 1 TUBE in 1 PACKAGE (21922-023-18) / 2 g in 1 TUBE

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": "a1fe87d9-27cf-4ff0-9e70-52b038882e36", "openfda": {"unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 PACKAGE (21922-023-17)  / 2 g in 1 BOTTLE, PUMP", "package_ndc": "21922-023-17", "marketing_start_date": "20221010"}, {"sample": false, "description": "1 TUBE in 1 PACKAGE (21922-023-18)  / 2 g in 1 TUBE", "package_ndc": "21922-023-18", "marketing_start_date": "20221010"}], "brand_name": "Docosanol", "product_id": "21922-023_a1fe87d9-27cf-4ff0-9e70-52b038882e36", "dosage_form": "CREAM", "product_ndc": "21922-023", "generic_name": "Docosanol", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Docosanol", "active_ingredients": [{"name": "DOCOSANOL", "strength": "100 mg/g"}], "application_number": "ANDA212385", "marketing_category": "ANDA", "marketing_start_date": "20221010", "listing_expiration_date": "20261231"}