Home NDC 85304-021 5% minoxidil with biotin topical solution
Product NDC 85304-021
11-digit product format 853040021
Labeler code 85304
Product ID 85304-021_425d9ed2-d050-5946-e063-6294a90a7649
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 2025-10-30
Substance BIOTIN; MINOXIDIL
Active strength .5; 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base 5% minoxidil with biotin topical solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BIOTIN .5 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 2691097 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 85304-021-01 5% minoxidil with biotin topical solution 60 mL in 1 BOTTLE SOLUTION 60 1 85304-021-01 5% minoxidil with biotin topical solution 6 in 1 PACKAGE SOLUTION 6 1 85304-021-02 5% minoxidil with biotin topical solution 8 in 1 PACKAGE SOLUTION 8 1 85304-021-02 5% minoxidil with biotin topical solution 60 mL in 1 BOTTLE SOLUTION 60 1
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 85304-021-01 85304002101 6 BOTTLE in 1 PACKAGE (85304-021-01) / 60 mL in 1 BOTTLE 6 bottle 2025-10-30 No No Current 85304-021-02 85304002102 8 BOTTLE in 1 PACKAGE (85304-021-02) / 60 mL in 1 BOTTLE 8 bottle 2025-10-30 No No Current