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 19 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pert 2 in 1 Advanced plusSALICYLIC ACIDSodalis USA, LLC0eaed46c-ae6f-0d58-e063-6394a90ad2a32025-08-13WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing BarPYRITHIONE ZINC 2%RoyceDerm LLC3b98a83d-9c3b-9522-e063-6294a90a70332025-08-05WarningsExact identifier
application number: M032
Earthmed FS Psoriasis reliefSALICYLIC ACIDEarthmed LLC3ba584bc-f40a-ce0a-e063-6394a90aebf72025-08-05WarningsExact identifier
application number: M032
Pert 2 in 1 Extra StrengthSALICYLIC ACIDSodalis USA, LLC25c8a46c-4400-709f-e063-6394a90a3f312025-07-30WarningsExact identifier
application number: M032
anti-fungalANTI-FUNGAL SHAMPOOGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd3b102d15-f2ce-5727-e063-6294a90a23a92025-07-29WarningsExact identifier
application number: M032
Earthmed Sport Anti itch and eczema reliefSALICYLIC ACIDEarthmed LLC3b14913b-3aab-9dd0-e063-6394a90a3b7f2025-07-29WarningsExact identifier
application number: M032
Soothing psoriasis and eczema reliefSALICYLIC ACIDCarolina Cannabis Creations L.L.C2bcad94d-1918-7f37-e063-6294a90a47442025-07-29WarningsExact identifier
application number: M032
DANDRX ANTI-DANDRUFFZINC PYRITHIONEdandRX LLC399fb507-2263-962f-e063-6394a90ae9a82025-07-10WarningsExact identifier
application number: M032
anti-dandruffANTI-DANDRUFF SHAMPOOGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd3979fb80-8091-c79e-e063-6394a90ae6182025-07-09WarningsExact identifier
application number: M032
CeraVe 2 in 1 Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc7f5ff142-15cb-44be-aa0e-ccd06de233002025-07-08WarningsExact identifier
application number: M032
5% Minoxidil and 5% Rosemary for Hair CareMINOXIDILTIKNOW LLC1bb386d2-70c6-c487-e063-6294a90a19da2025-07-07WarningsExact identifier
application number: M032
Red Scalpfixer Anti DandruffPYRINTHIONE ZINCOrange Lab, Inc386c83c3-8d23-b3b0-e063-6394a90a27ee2025-07-01WarningsExact identifier
application number: M032
Dermabon Multi Symptom Psoriasis ControlCOAL TARDermabon de Chihuahua, S.A. de C.V.d5b739ba-e332-41f6-9343-6ad5cc9813442025-07-01WarningsExact identifier
application number: M032
PHARMBANNER Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.383926b7-997b-af1e-e063-6394a90a506d2025-06-23WarningsExact identifier
application number: M032
Brickell Mens Products Relieving Anti-DandruffSALICYLIC ACIDBRICKELL BRANDS LLC7ba3b13b-cb78-4df8-8719-c88e556643b42025-06-16WarningsExact identifier
application number: M032
VENROCKPIROCTONE OLAMINE AND SALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.372feca7-f6f1-cd38-e063-6294a90a3bfe2025-06-12WarningsExact identifier
application number: M032
Neutrogena T/Sal TherapeuticSALICYLIC ACIDKenvue Brands LLC54707f0f-6025-4dc3-8be8-7a38bb1363b82025-06-05WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SAaae04d08-9d0c-43bd-89c2-741884de3bea2025-06-04WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDL'Oreal USA Products Incbcffd505-82bd-45ce-9ad0-64a9e63f62b52025-06-04WarningsExact identifier
application number: M032
UCHOIZE S2 Balance Anti-DandruffUCHOIZE S2 BALANCE ANTI-DANDRUFF SHAMPOODreamwise International Corp36a5efa8-0617-868d-e063-6394a90a17052025-06-03WarningsExact 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