docosanol

Generic: docosanol

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docosanol
Generic Name docosanol
Labeler aurohealth llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

docosanol 100 mg/g

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-019
Product ID 58602-019_a0ddfc5f-c31c-4615-9545-11777b318454
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217090
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602019
Hyphenated Format 58602-019

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 ANDA217090 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 PACKAGE (58602-019-08) / 2 g in 1 TUBE
  • 2 TUBE in 1 PACKAGE (58602-019-09) / 2 g in 1 TUBE
  • 1 TUBE in 1 PACKAGE (58602-019-11) / 3 g in 1 TUBE
  • 1 TUBE in 1 PACKAGE (58602-019-12) / 3 g in 1 TUBE
  • 2 TUBE in 1 PACKAGE (58602-019-13) / 3 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 PACKAGE (58602-019-15) / 2 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 PACKAGE (58602-019-16) / 2 g in 1 BOTTLE, PUMP
  • 2 BOTTLE, PUMP in 1 PACKAGE (58602-019-17) / 2 g in 1 BOTTLE, PUMP
  • 1 TUBE in 1 PACKAGE (58602-019-24) / 2 g in 1 TUBE
source: ndc

Packages (9)

58602-019-08 1 TUBE in 1 PACKAGE (58602-019-08) / 2 g in 1 TUBE 58602-019-09 2 TUBE in 1 PACKAGE (58602-019-09) / 2 g in 1 TUBE 58602-019-11 1 TUBE in 1 PACKAGE (58602-019-11) / 3 g in 1 TUBE 58602-019-12 1 TUBE in 1 PACKAGE (58602-019-12) / 3 g in 1 TUBE 58602-019-13 2 TUBE in 1 PACKAGE (58602-019-13) / 3 g in 1 TUBE 58602-019-15 1 BOTTLE, PUMP in 1 PACKAGE (58602-019-15) / 2 g in 1 BOTTLE, PUMP 58602-019-16 1 BOTTLE, PUMP in 1 PACKAGE (58602-019-16) / 2 g in 1 BOTTLE, PUMP 58602-019-17 2 BOTTLE, PUMP in 1 PACKAGE (58602-019-17) / 2 g in 1 BOTTLE, PUMP 58602-019-24 1 TUBE in 1 PACKAGE (58602-019-24) / 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": "a0ddfc5f-c31c-4615-9545-11777b318454", "openfda": {"unii": ["9G1OE216XY"], "rxcui": ["797534"], "spl_set_id": ["9f361f24-a0a1-4e43-a158-8c830c9adca7"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (58602-019-08)  / 2 g in 1 TUBE", "package_ndc": "58602-019-08", "marketing_start_date": "20240301"}, {"sample": false, "description": "2 TUBE in 1 PACKAGE (58602-019-09)  / 2 g in 1 TUBE", "package_ndc": "58602-019-09", "marketing_start_date": "20240301"}, {"sample": false, "description": "1 TUBE in 1 PACKAGE (58602-019-11)  / 3 g in 1 TUBE", "package_ndc": "58602-019-11", "marketing_start_date": "20240301"}, {"sample": false, "description": "1 TUBE in 1 PACKAGE (58602-019-12)  / 3 g in 1 TUBE", "package_ndc": "58602-019-12", "marketing_start_date": "20240301"}, {"sample": false, "description": "2 TUBE in 1 PACKAGE (58602-019-13)  / 3 g in 1 TUBE", "package_ndc": "58602-019-13", "marketing_start_date": "20240301"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 PACKAGE (58602-019-15)  / 2 g in 1 BOTTLE, PUMP", "package_ndc": "58602-019-15", "marketing_start_date": "20240301"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 PACKAGE (58602-019-16)  / 2 g in 1 BOTTLE, PUMP", "package_ndc": "58602-019-16", "marketing_start_date": "20240301"}, {"sample": false, "description": "2 BOTTLE, PUMP in 1 PACKAGE (58602-019-17)  / 2 g in 1 BOTTLE, PUMP", "package_ndc": "58602-019-17", "marketing_start_date": "20240301"}, {"sample": false, "description": "1 TUBE in 1 PACKAGE (58602-019-24)  / 2 g in 1 TUBE", "package_ndc": "58602-019-24", "marketing_start_date": "20240301"}], "brand_name": "DOCOSANOL", "product_id": "58602-019_a0ddfc5f-c31c-4615-9545-11777b318454", "dosage_form": "CREAM", "product_ndc": "58602-019", "generic_name": "DOCOSANOL", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DOCOSANOL", "active_ingredients": [{"name": "DOCOSANOL", "strength": "100 mg/g"}], "application_number": "ANDA217090", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}