Home NDC 85304-001-02 5% Minoxidil with Biotin
Product NDC 85304-001
Requested package NDC 85304-001-02
11-digit product format 853040001
Labeler code 85304
Product ID 85304-001_300bc4e7-e796-4f32-e063-6394a90a1e67
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form SOLUTION
Route TOPICAL
Labeler Guangzhou Borderless Technology Co., Ltd.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-11
Substance BIOTIN; MINOXIDIL
Active strength .2; 5 g/100mL; g/100mL
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base 5% Minoxidil with Biotin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BIOTIN .2 g/100mL MINOXIDIL 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6SO6U10H04 Internal UNII lookup 5965120SH1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2707693 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85304-001-02 5% Minoxidil with Biotin 2 in 1 BOX SOLUTION 2 1 85304-001-02 5% Minoxidil with Biotin 60 mL in 1 BOTTLE SOLUTION 60 1 85304-001-04 5% Minoxidil with Biotin 4 in 1 BOX SOLUTION 4 1 85304-001-04 5% Minoxidil with Biotin 60 mL in 1 BOTTLE SOLUTION 60 1 85304-001-06 5% Minoxidil with Biotin 60 mL in 1 BOTTLE SOLUTION 60 1 85304-001-06 5% Minoxidil with Biotin 6 in 1 BOX SOLUTION 6 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85304-001 5% MINOXIDIL WITH BIOTIN (MINOXIDIL) SOLUTION [GUANGZHOU BORDERLESS TECHNOLOGY CO., LTD.] 1 Current NDC, 6 package rows 20250312_300bc4e7-e795-4f32-e063-6394a90a1e67.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85304-001-02 85304000102 2 BOTTLE in 1 BOX (85304-001-02) / 60 mL in 1 BOTTLE 2 bottle 2025-03-11 No No Current