FDA.reportPublic FDA data

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
IngredientStrength
FINASTERIDE.1 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
1d44a75c-c940-680c-e063-6394a90a5839Available 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 25 of 31 · 613 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Dandruff Conditioner 2 in 1 Itchy Scalp Anti-dandruffPYRITHIONE ZINCWalgreen Company52594e2b-dd1b-4618-b1ab-9f65ae26a3582024-11-04WarningsExact identifier
application number: M032
Walgreens Dandruff Plus Conditioner 2 in 1 Anti-dandruffPYRITHIONE ZINCWalgreen Company12ccb5aa-4e0d-467b-a03c-dddd6da0a9c92024-11-04WarningsExact identifier
application number: M032
Walgreens Dandruff Plus Conditioner 2 in 1 Dry Scalp Anti-dandruffPYRITHIONE ZINCWalgreen Company0fed00b3-cac6-4add-b979-a3fe112bcff32024-11-04WarningsExact identifier
application number: M032
Walgreens Dandruff Itchy Dry Scalp Defense Anti-dandruffPYRITHIONE ZINCWalgreen Company06b37d44-9ebf-44ed-8e8b-492905d85bdc2024-11-01WarningsExact identifier
application number: M032
Walgreens Dandruff Conditioner 2 in 1 Itchy Scalp Anti-dandruffPYRITHIONE ZINCWalgreen Company5b679112-8790-416f-9bb4-8e64d3e279bc2024-11-01WarningsExact identifier
application number: M032
Walgreens Dandruff Itchy Dry Scalp Defense Plus Vitamins and Botanicals Anti-dandruffSALICYLIC ACIDWalgreen Company2776d45c-6597-4c13-81e6-29d9248e9e562024-11-01WarningsExact identifier
application number: M032
Walgreens Dandruff and Conditioner Cleansing and Conditioning Anti-dandruffSELENIUM SULFIDEWalgreen Companydbcaeae8-4680-41d8-84e2-896183d2121d2024-11-01WarningsExact identifier
application number: M032
Walgreens Dandruff Maximum Strength Anti-dandruffSELENIUM SULFIDEWalgreen Company0187b034-44d7-4b84-af04-d018bc9750f32024-11-01WarningsExact identifier
application number: M032
Dermarest Psoriasis MedicatedSALICYLIC ACIDInsight Pharmaceuticals LLCc6a64946-bafd-449f-90cc-e2f6201285f32024-10-25WarningsExact identifier
application number: M032
DermaSolve MedicatedSALICYLIC ACIDFortitude Health, LLC253e2687-6e8b-48ec-e063-6394a90aa20b2024-10-24WarningsExact identifier
application number: M032
FAMILY Wellness FRESH and CLEAN DANDRUFF PLUS CONDITIONER 2 IN 1 Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC4a9a803a-44ac-4e29-9c47-0073b728ff192024-10-22WarningsExact identifier
application number: M032
DermaSolve MedicatedSALICYLIC ACIDFortitude Health, LLC24fea3b2-1f0a-e289-e063-6394a90a56412024-10-21WarningsExact identifier
application number: M032
FAMILY Wellness EVERYDAY CLEAN 2 IN 1 DANDRUFF PLUS CONDITIONER Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC220955ec-592c-421f-9f4e-545ff3843ee02024-10-21WarningsExact identifier
application number: M032
FAMILY Wellness MAXIMUM STRENGTH DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDEFAMILY DOLLAR SERVICES INC41a808e1-67a7-4b29-8ec4-d6c13cf622432024-10-21WarningsExact identifier
application number: M032
Family Wellness Therapeutic Tplus PLUS Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARFAMILY DOLLAR SERVICES INC46471dfa-2322-464f-8d00-bf49d8eb4e182024-10-21WarningsExact identifier
application number: M032
As I Am Dry and Itchy Scalp Care ConditionerPYRITHIONE ZINCSalon Commodities, Inc.71eb9451-df12-66e8-e053-2a95a90a2f692024-10-09WarningsExact identifier
application number: M032
As I Am Dry and Itchy Scalp Care TreatmentSALICYLIC ACIDSalon Commodities, Inc.71ec25c5-6da5-670a-e053-2a95a90a1b8c2024-10-09WarningsExact identifier
application number: M032
KeraCare Dry and Itchy Scalp Anti-DandruffPYRITHIONE ZINCAvlon Industries, Inc.6e7524d7-b280-485a-815e-8af078e8acda2024-10-09WarningsExact identifier
application number: M032
KeraCare Dry and Itchy Scalp Anti-DandruffPYRITHIONE ZINCAvlon Industries, Inc.5d501ba0-a6f9-4f0d-86d5-0e8d9302737f2024-10-09WarningsExact identifier
application number: M032
As I Am Dry and Itchy Scalp CarePYRITHIONE ZINCSalon Commodities, Inc.71ea4820-4160-41c2-e053-2a95a90a127d2024-10-09WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84539-001-018453900010190 g in 1 BOTTLE (84539-001-01) 90 g2024-07-15NoNoCurrent