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 27 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDCVS Healthbd32def7-b002-4e12-89ad-b7d13754d82a2024-09-24WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Healthcff51af6-84de-4ba5-ac99-9bc42a65c9a52024-09-24WarningsExact identifier
application number: M032
VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical StrengthSALICYLIC ACIDVerb Products Inc.18bddd16-e001-445c-9647-801defc1d5272024-09-03WarningsExact identifier
application number: M032
Denorex Severe ItchCOAL TARNeoteric Cosmetics, Inc.213ccbc4-2f52-58b6-e063-6294a90ae2482024-09-03WarningsExact identifier
application number: M032
SORARESALSALICYLIC ACIDSummer Herbal Inc.af734362-057b-4011-bf4e-c4e4dd67f68c2024-09-03WarningsExact identifier
application number: M032
ion 2 in 1 anti-dandruff Anti-dandruffPYRITHIONE ZINCArcadia Beauty Labs LLC38631b45-b222-4a25-8180-25970dabdffc2024-08-28WarningsExact identifier
application number: M032
TopCare Therapeutic Anti-Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARTopco Associates LLC070a5249-0b37-4b7f-a55b-609a0d8504d22024-08-22WarningsExact identifier
application number: M032
J1003005 Jason Dandruff ReliefSULFUR, SALICYLIC ACIDThe Hain Celestial Group, Inc.625e8306-78c4-3317-e053-2991aa0afe812024-07-31WarningsExact identifier
application number: M032
Jason Dandruff Relief Treatment 2 in 1ZINC PYRITHIONEThe Hain Celestial Group, Inc4afa1048-7a76-4562-8dcf-9252d5bfa48a2024-07-31WarningsExact identifier
application number: M032
Alba Natural Acnedote AstringentSALICYLIC ACIDThe Hain Celestial Group, Inc.939f90e7-e1de-4ca3-a484-90f1b87797d62024-07-31WarningsExact identifier
application number: M032
Matrix Biolage ScalpSync AntidandruffPYRITHIONE ZINCL'Oreal USA Products Inc8564f2cf-b680-4e2c-8451-f345c9852c1a2024-07-18WarningsExact identifier
application number: M032
Pete and Pedro Control Anti Itch DandruffCOAL TARPETE AND PEDRO LLC34ec83c1-31b9-4ecc-8bd2-898fd85364ba2024-07-02WarningsExact identifier
application number: M032
VICHY LABORATOIRES DERCOS Selenium Sulfide Anti-DandruffSELENIUM SULFIDE, MICRONIZEDL'Oreal USA Products Incdeae26e0-53f0-442b-959c-0f925a102db02024-06-25WarningsExact identifier
application number: M032
VICHY LABORATOIRES Dercos Selenium Sulfide Anti-dandruffSELENIUM SULFIDE, MICRONIZEDPRODUCTOS CAPILARES L'OREAL SA3fcb03fc-552a-4b02-981e-2ff84142da962024-06-25WarningsExact identifier
application number: M032
Dercos Salicylic Acid Anti-Dandruff SerumSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SA024f9299-ee6c-48e3-89e7-96b7db060c302024-06-20WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp CareSALICYLIC ACIDTAI GUK PHARM. CO., LTD1e572a86-9115-4597-e063-6394a90a484e2024-05-31WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1SALICYLIC ACIDTAI GUK PHARM. CO., LTD1e572a97-1a38-8360-e063-6394a90a47a32024-05-31WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp CareSALICYLIC ACIDLG H&H CO., LTD.1e584724-7059-38ab-e063-6394a90aceb72024-05-31WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1SALICYLIC ACIDLG H&H CO., LTD.1e584724-705a-38ab-e063-6394a90aceb72024-05-31WarningsExact identifier
application number: M032
Thera-GelCOAL TARMajor Pharmaceuticals1c18fde9-d39b-4339-8f62-3f352d4502912024-05-28WarningsExact 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