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 11 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everyday Clean 2 in 1PYRITHIONE ZINCWinCo Foods, LLC8bd391ae-0eeb-4e7d-b1e5-20e4adb1da172026-02-12Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean 2 in 1PYRITHIONE ZINCYour Military Exchangesa62b282f-e928-42bb-b595-d5f2066aac632026-02-12Warnings, Adverse reactionsExact identifier
application number: M032
natouchPYRITHIONE ZINCNatouch LLC0f330e2d-25d7-5e0e-e063-6394a90acda92026-02-10WarningsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCRetail Business Services, LLC8fb44204-b763-4aa5-a6db-94d1b4d98b652026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCRetail Business Services, LLCc1d8c237-1ca8-4fdb-ba94-787d3a9e61112026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp DandruffPYRITHIONE ZINCRetail Business Services, LLC592ec7c5-44b8-405b-88a2-f02aa6c620f02026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCRetail Business Services, LLC37357176-913d-4dd7-a565-ad21d4ad60a82026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCRetail Business Services, LLCc8c82495-f09a-4ec1-9036-e464845e02f92026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCRetail Business Services, LLCec9d36ae-cf4e-4841-a13e-5cb0fe64c4fa2026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCRetail Business Services, LLC841429c3-e15c-41cc-9ca8-6b5a21a215872026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCPublix Super Markets, Inc.56c2b8c2-69ea-4343-ae69-43f5966261c22026-02-05Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCPublix Super Markets, Inc.8a204a2c-6dcb-4fc4-b265-9b95da2042362026-02-05Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCHarris Teeter8594a944-a67e-4dbe-8d31-7099410ff4842026-02-04Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCAmazon.Com Services LLCe30896df-e4b2-4b1f-a226-a26055a4a1212026-02-03Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCDemoulas Super Markets, Inc712d847f-2888-4423-813f-03ec4a8f37982026-02-03Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCDemoulas Super Markets, Inc584df95a-7fc7-4b4b-b703-c423248444ed2026-02-03Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCDemoulas Super Markets, Inc6515b35c-49cb-41b4-9eb5-46dee482079e2026-02-03Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCCVS Pharmacy, Inc.5edfe1d7-9f8d-401f-bde5-720799940c172026-02-02Warnings, Adverse reactionsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLC34c4abb5-6f96-4866-a37f-4f9be6c43f2b2026-01-30WarningsExact identifier
application number: M032
NATUREPLEX PSORIASISSALICYLIC ACIDNatureplex, LLC1efa3e8d-f80b-44f4-a233-187e3329dd8f2026-01-29WarningsExact 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