FDA.reportPublic FDA data

anti dandruff SHAMPOOS

Product NDC
85434-002
11-digit product format
854340002
Labeler code
85434
Product ID
85434-002_31392f0f-a6c5-1cfb-e063-6294a90a4d36
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangdong Quaker Daily Chemical Co., LTD
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-26
Substance
PYRITHIONE ZINC
Active strength
1 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
anti dandruff SHAMPOOS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC1 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209884Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31392f0f-a6c4-1cfb-e063-6294a90a4d36Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85434-002-01anti dandruff SHAMPOOS473 mL in 1 BOTTLELIQUID4731
85434-002-01anti dandruff SHAMPOOS1 in 1 BOXLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85434-002ANTI DANDRUFF SHAMPOOS (PYRITHIONE ZINC) LIQUID [GUANGDONG QUAKER DAILY CHEMICAL CO., LTD]1Current NDC, 2 package rows20250327_31392f0f-a6c4-1cfb-e063-6294a90a4d36.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 12 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.482c0243-1073-f578-e063-6294a90adf5c2026-01-15WarningsExact identifier
application number: M032
Kenkoderm Psoriasis MoisturizingSALICYLIC ACIDOlympus Trading Company, LLCca9e4168-dfe9-4fb0-b78d-83b9fe5205f82026-01-09WarningsExact identifier
application number: M032
Kenkoderm PsoriasisSALICYLIC ACIDOlympus Trading Company, LLC9143edff-9809-4620-96fe-6293d5b75df82026-01-09WarningsExact identifier
application number: M032
DZUL ANTI-DANDRUFF CONDITIONERPYRITHIONE ZINCCaball Sales, Inc.05f29038-f14f-4285-e063-6294a90ac9802026-01-08WarningsExact identifier
application number: M032
DZUL ANTI-DANDRUFFZINC PYRITHIONECaball Sales, Inc.05e3fac4-c0ce-cbb9-e063-6294a90ac0362026-01-08WarningsExact identifier
application number: M032
Mens Rogaine 2% Salicylic Acid Anti-Dandruff Plus ConditionerSALICYLIC ACIDKenvue Brands LLC44906677-88a2-7c68-e063-6294a90a30172026-01-02WarningsExact identifier
application number: M032
Max OUTBENZALKONIUM CHLORIDEUnico475903d2-a0b0-5d29-e063-6394a90a528f2026-01-01WarningsExact identifier
application number: M032
Flakes Cedar Mint Anti DandruffPYRITHIONE ZINCCosco International, Inc.8575e7a0-4290-40a0-949c-317951b440b82026-01-01WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dandruff Defense Intensive Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb6ad7707-9d02-31a6-e053-2a95a90ae7ad2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Clinical Strength Dandruff Defense Intensive Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb6ada541-f12b-76f2-e053-2a95a90a52862025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Lemon Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companye7903f3d-9c5a-f397-e053-2995a90a78952025-12-31WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Dry Scalp Care with Almond and Coconut OilPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyed0bd699-c243-60f4-e053-2995a90a781f2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Shea ButterPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf80a1580-38ba-3dae-e053-6394a90aff5d2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Ginger 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf80a83cc-1174-3ec3-e053-6394a90ab0122025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Shea Butter Hair and Scalp ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf7ff4442-5d3f-034a-e053-6394a90a686d2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Clinical Dry Scalp Rescue KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company1a3ac96a-04ec-6865-e063-6394a90a9fb82025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Deep Scalp Hydration DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf80aee91-5643-ebbc-e053-6294a90aa5ab2025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Deep Scalp Cleanse DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf81e8a83-db95-8246-e053-6294a90a40a42025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Deep Scalp Cleanse 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf81eb5d0-e392-0152-e053-6294a90a29072025-12-31WarningsExact identifier
application number: M032
Head and Shoulders Deep Scalp Hydration 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyf80e8a60-2b0f-dce2-e053-6394a90ab2752025-12-31WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN31392f0f-a6c4-1cfb-e063-6294a90a4d361
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD31392f0f-a6c4-1cfb-e063-6294a90a4d361
209884zinc pyrithione 1 % Medicated ConditionerSY31392f0f-a6c4-1cfb-e063-6294a90a4d361
209884zinc pyrithione 1 % Medicated ShampooSY31392f0f-a6c4-1cfb-e063-6294a90a4d361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85434-002-01854340002011 BOTTLE in 1 BOX (85434-002-01) / 473 mL in 1 BOTTLE1 bottle2025-03-26NoNoCurrent