DOCOSANOL

Generic: DOCOSANOL

Labeler: H2-Pharma, LLC
NDC Directory HUMAN OTC DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name DOCOSANOL
Generic Name DOCOSANOL
Labeler H2-Pharma, LLC
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

DOCOSANOL 100 mg/g

Identifiers & Regulatory

Product NDC 61269-981
Product ID 61269-981_a702c716-68dd-4a12-b584-44d31dfd84e7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208754
Marketing Start 2021-06-29
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269981
Hyphenated Format 61269-981

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 ANDA208754 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 PACKAGE (61269-981-35) / 2 g in 1 TUBE
source: ndc

Packages (1)

61269-981-35 1 TUBE in 1 PACKAGE (61269-981-35) / 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": "a702c716-68dd-4a12-b584-44d31dfd84e7", "openfda": {"unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["a921a653-aedd-43c2-b84f-429a4aada79a"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (61269-981-35)  / 2 g in 1 TUBE", "package_ndc": "61269-981-35", "marketing_end_date": "20260228", "marketing_start_date": "20210629"}], "brand_name": "DOCOSANOL", "product_id": "61269-981_a702c716-68dd-4a12-b584-44d31dfd84e7", "dosage_form": "CREAM", "product_ndc": "61269-981", "generic_name": "DOCOSANOL", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DOCOSANOL", "active_ingredients": [{"name": "DOCOSANOL", "strength": "100 mg/g"}], "application_number": "ANDA208754", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20210629"}