DermaZinc

Product NDC
35324-003
11-digit product format
353240003
Labeler code
35324
Product ID
35324-003_35fc83a7-c563-853f-e063-6294a90a4682
Type
HUMAN OTC DRUG
Nonproprietary name
pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
WynnPharm Inc
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-29
Substance
PYRITHIONE ZINC
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
DermaZinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
244458Internal RxNorm lookup
1721127Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e71e87ba-2a62-44f3-e053-2995a90a8b11Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35324-003-08DermaZinc240 mL in 1 BOTTLE, DISPENSINGSHAMPOO2404
35324-003-16DermaZinc473 mL in 1 BOTTLE, DISPENSINGSHAMPOO4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35324-003DERMAZINC (PYRITHIONE ZINC) SHAMPOO [WYNNPHARM INC]4Current NDC, Legacy NDC, 2 package rows20250527_e71e87ba-2a62-44f3-e053-2995a90a8b11.zip

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 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721127Dermazinc 2 % Medicated ShampooPSNe71e87ba-2a62-44f3-e053-2995a90a8b114
244458zinc pyrithione 2 % Medicated ShampooPSNe71e87ba-2a62-44f3-e053-2995a90a8b114
1721127zinc pyrithione 20 MG/ML Medicated Shampoo [Dermazinc]SBDe71e87ba-2a62-44f3-e053-2995a90a8b114
244458zinc pyrithione 20 MG/ML Medicated ShampooSCDe71e87ba-2a62-44f3-e053-2995a90a8b114
1721127Dermazinc 2 % Medicated ShampooSYe71e87ba-2a62-44f3-e053-2995a90a8b114
1721127Dermazinc 20 MG/ML Medicated ShampooSYe71e87ba-2a62-44f3-e053-2995a90a8b114
244458zinc pyrithione 2 % Medicated ShampooSYe71e87ba-2a62-44f3-e053-2995a90a8b114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35324-003-0835324000308240 mL in 1 BOTTLE, DISPENSING (35324-003-08) 240 ml2022-08-290000-00-00NoNoCurrent
35324-003-1635324000316473 mL in 1 BOTTLE, DISPENSING (35324-003-16) 473 ml2025-05-25NoNoCurrent