Home NDC 84539-002 JOHNSON FOAM PRO
Product NDC 84539-002
11-digit product format 845390002
Labeler code 84539
Product ID 84539-002_581d631c-ecc9-940c-e063-6294a90aa0e1
Type HUMAN OTC DRUG
Nonproprietary name FINASTERIDE FOAM WITH 5% MINOXIDIL
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler JOHNSON BIOPHARMACEUTICAL INC.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-21
Substance FINASTERIDE; MINOXIDIL
Active strength .25; 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 PRO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FINASTERIDE .25 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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84539-002-01 84539000201 90 g in 1 BOTTLE (84539-002-01) 90 g 2024-11-21 No No Current