FDA.reportPublic FDA data

URBAN WASH DANDRUFF

Product NDC
80801-101
11-digit product format
808010101
Labeler code
80801
Product ID
80801-101_5b2e709c-6c73-3bb9-e063-6394a90a407e
Type
HUMAN OTC DRUG
Nonproprietary name
pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Primal Elements
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-01
Substance
PYRITHIONE ZINC
Active strength
.3 g/100mL
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
URBAN WASH DANDRUFF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC.3 g/100mL

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 24 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc PyrithioneZINC PYRITHIONEHarry's Inc.a4fecf11-dd44-a06e-e053-2995a90afacf2024-12-16WarningsExact identifier
application number: M032
BYE-BYE CRADLE CAPPYRITHIONE ZINCTubby Toddf4398ad2-7da5-aff0-e053-2995a90ae2662024-12-12WarningsExact identifier
application number: M032
NATURALTECH PURIFYING ANTI-DANDRUFFPYRITHIONE ZINCDavines S.p.A.1f7e0265-0543-4ef9-addf-4d514d0eedfe2024-12-11WarningsExact identifier
application number: M032
NATURALTECH PURIFYING ANTI-DANDRUFFSELENIUM SULFIDEDavines S.p.A.369a24fd-3882-4fad-b57a-45806090aff12024-12-11WarningsExact identifier
application number: M032
Skin Renewing CreamSALICYLIC ACIDAllure Labsb5ea8f33-8f18-7464-e053-2a95a90a39b22024-12-09WarningsExact identifier
application number: M032
Skin Renewing CreamSALICYLIC ACIDAllure Labsfa54cf42-3ba7-b7b3-e053-6394a90aa7a02024-12-09WarningsExact identifier
application number: M032
Satinique Anti Dandruff Scalp and HairSALICYLIC ACIDAccess Business Group LLC03252c61-c51b-4e87-a06d-a61b8393704f2024-12-09WarningsExact identifier
application number: M032
Dry Skin Relief BarSALICYLIC ACIDCP Skin Health Group, Inc.eceb73b0-4c2f-4989-a3aa-a6553bc682522024-12-09WarningsExact identifier
application number: M032
Head and Shoulders Dual Pack Green ApplePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc8208bac-9d32-7694-e053-2a95a90a746c2024-11-27WarningsExact identifier
application number: M032
VanicreamPYRITHIONE ZINCPharmaceutical Specialties, Inc.d124a093-f739-0666-e053-2995a90a52ed2024-11-27WarningsExact identifier
application number: M032
LEAHUE MADHUCA TONICSALICYLIC ACIDBio-interchange Co.81454c8a-ddcf-7cef-e053-2991aa0a53c22024-11-27WarningsExact identifier
application number: M032
Hairitage Wash It Away Anti-Dandruff for Oily, Flaky ScalpSELENIUM SULFIDEMaesa, LLC.b09c3b0d-564e-45e4-b6ff-c1f0c12a95212024-11-13WarningsExact identifier
application number: M032
Hairitage Wash It Away Anti-Dandruff for Dry, Flaky ScalpSELENIUM SULFIDEMaesa, LLC.fa5d4ee3-fbeb-4379-bbd3-2b5b2cc454302024-11-12WarningsExact identifier
application number: M032
Marcs 2 in 1 Everyday Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.1daaa2c9-fbc7-4aa5-9772-e157109320662024-11-11WarningsExact identifier
application number: M032
Marcs Dry Scalp Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.ffab6ca6-7c8f-4080-836c-635a6ba3c0bb2024-11-11WarningsExact identifier
application number: M032
Marcs Everyday Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.69baf948-25fc-41d6-8980-23634634953b2024-11-11WarningsExact identifier
application number: M032
bhs beautiful hair and scalpSCALP HYDRATE ANTI-DANDRUFF SHAMPOOConopco, Inc. d/b/a/ Unilevere4159032-fd45-82a3-e053-2a95a90a79352024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpSMOOTH FRIZZ ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevere3d78025-4935-c04b-e053-2995a90a609f2024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpVIBRANT COLOR ANTI-DANDRUFF CONDITIONERConopco, Inc. d/b/a/ Unilevere3d7c24a-cc18-c455-e053-2a95a90a21842024-11-07WarningsExact identifier
application number: M032
bhs beautiful hair and scalpFRESH DETOX 2 IN 1 ANTI-DANDRUFF SHAMPOOConopco, Inc. d/b/a/ Unilevercba3fe82-63ba-01e2-e053-2a95a90a5b822024-11-07WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80801-101-0180801010101355 mL in 1 BOTTLE, PLASTIC (80801-101-01) 355 ml2023-05-01NoNoCurrent