JOHNSON FOAM PRO

Product NDC
84539-002
Requested package NDC
84539-002-01
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
IngredientStrength
FINASTERIDE.25 g/100g
MINOXIDIL5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57GNO57U7GInternal UNII lookup
5965120SH1Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
27697b1c-f713-f7e0-e063-6394a90a7514Available on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JOHNSON FOAM PROFINASTERIDE FOAM WITH 5% MINOXIDILJOHNSON BIOPHARMACEUTICAL INC.27697b1c-f713-f7e0-e063-6394a90a75142026-08-02WarningsExact identifier
ndc (package): 84539-002-01
ndc (product): 84539-002
ndc11 (package): 84539000201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84539-002-018453900020190 g in 1 BOTTLE (84539-002-01) 90 g2024-11-21NoNoCurrent