Home NDC 85038-008-03 5% Minoxidil Hair Regrowth Serum With Biotin
Product NDC 85038-008
Requested package NDC 85038-008-03
11-digit product format 850380008
Labeler code 85038
Product ID 85038-008_5356bc3d-7bbb-8e97-e063-6394a90af9c8
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil
Dosage form LIQUID
Route TOPICAL
Labeler Lianjiang Shanlilai E-commerce Co., Ltd.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-03
Substance BIOTIN; MINOXIDIL
Active strength .005 g/mL; .05 g/mL
Pharmacologic classes Arteriolar Vasodilation [PE]; Arteriolar Vasodilator [EPC]
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base 5% Minoxidil Hair Regrowth Serum With Biotin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BIOTIN .005 g/mL MINOXIDIL .05 g/mL
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 85038-008-03 85038000803 2 BOTTLE in 1 PACKAGE (85038-008-03) / 50 mL in 1 BOTTLE 2 bottle 2026-06-03 0 Current