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 28 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
upandup Anti-dandruff with Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDTARGET CORPORATION482332f8-0db4-4ec7-81e9-c4efbba16a262024-05-20WarningsExact identifier
application number: M032
True Plus Real Therapeutic T PLUS EXTRA STRENGTH COAL TAR TAR DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGarcoa, Inc.20116e1e-56f1-4018-99ef-758de7fc24642024-05-10WarningsExact identifier
application number: M032
up and up Moisturizing Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDETARGET CORPORATIONe315b2d8-304d-4807-9594-9286e9b642ef2024-05-10WarningsExact identifier
application number: M032
amazon basics therapeutic tar gel anti-dandruff Extra Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARAMAZON.COM SERVICES LLC0464b4ff-1be1-4d84-b7fd-b771ebc1e16c2024-05-09WarningsExact identifier
application number: M032
Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitisSELENIUM SULFIDEWalgreen Companycc83427d-49e6-4a20-9d03-9ec8ce27e4872024-05-09WarningsExact identifier
application number: M032
meijer MEDICATED selenium sulfide Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDEMeijer Distribution, Incc8dee061-3362-400f-aa59-93ec0b8125ba2024-05-01WarningsExact identifier
application number: M032
Walgreens Dandruff With Menthol/Selenium Sulfide Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDEWalgreen Company70c7b400-a295-4b99-8673-e6a38343d76f2024-05-01WarningsExact identifier
application number: M032
up and up Medicated Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDETARGET CORPORATIONa516282f-ed6b-4e94-b269-ea34f700dd692024-04-25WarningsExact identifier
application number: M032
Walgreens Tplus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDWalgreen Company339d390e-0b09-4c42-af1f-9465daa9f7c92024-04-22WarningsExact identifier
application number: M032
Walgreens Everyday Clean Dandruff Anti-DandruffPYRITHIONE ZINCWalgreen Company930d92a9-d0bc-42e1-873e-5c27e93a39b52024-04-22WarningsExact identifier
application number: M032
Rugby Anti-DandruffSELENIUM SULFIDERugby Laboratoriesf8942f2b-32fb-4a2d-b0cf-0f2d1c6974c22024-03-14WarningsExact identifier
application number: M032
Leader Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-DandruffSELENIUM SULFIDECardinal Health, 110 dba LEADER3f64a2ef-a415-49b0-bf14-eb4da66d511f2024-03-13WarningsExact identifier
application number: M032
Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasisSALICYLIC ACIDCardinal Health, 110 dba LEADER509434a9-50c4-4337-8e5b-17bdc667d23b2024-03-13WarningsExact identifier
application number: M032
meijer therapeutic t plus plus tar gel dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARMeijer Distribution, Incf7cce683-6e1f-4214-a38b-37eb046b7f4d2024-03-05WarningsExact identifier
application number: M032
Sebex Antidandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACID, SULFURRugby Laboratoriesaec81d61-1d28-490f-9654-f66bd4a30ffa2024-03-01WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Conditioner Coconut and Shea ButterPYRITHIONE ZINCRejoice International Inc.e69319c8-c49c-415b-a7ea-ec6e77fa625c2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Conditioner mint and eucalyptusPYRITHIONE ZINCRejoice International Inc.08330f44-45e2-47cb-bd2e-cef15ba61aee2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea ButterPYRITHIONE ZINCRejoice International Inc.7d9bf611-db24-4915-9b13-b7b36f47711f2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptusPYRITHIONE ZINCRejoice International Inc.b05742fe-692f-45a3-9de0-5f3f08642d782024-02-28WarningsExact identifier
application number: M032
XtraCare Dandruff Hair WashSALICYLIC ACIDRejoice International1902e6bb-e829-4b1a-b85a-1394913c77ca2024-02-28WarningsExact 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