Home NDC 84539-001 JOHNSON FOAM
Product NDC 84539-001
11-digit product format 845390001
Labeler code 84539
Product ID 84539-001_581d5ca7-ed15-8a92-e063-6294a90aa8a8
Type HUMAN OTC DRUG
Nonproprietary name MINOXIDIL
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler JOHNSON BIOPHARMACEUTICAL INC.
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-15
Substance FINASTERIDE; MINOXIDIL
Active strength .1; 5 g/100g; g/100g
Pharmacologic classes 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 JOHNSON FOAM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FINASTERIDE .1 g/100g MINOXIDIL 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57GNO57U7G Internal UNII lookup 5965120SH1 Internal UNII 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 31 of 31 · 613 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84539-001-01 84539000101 90 g in 1 BOTTLE (84539-001-01) 90 g 2024-07-15 No No Current