FDA.reportPublic FDA data

Pyrithione Zinc

Product NDC
11344-131
11-digit product format
113440131
Labeler code
11344
Product ID
11344-131_4db2aaf4-5cb0-d9e5-e063-6294a90aa4ea
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-23
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
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
Pyrithione Zinc
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC10 mg/mL

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
4db2aaf4-5caf-d9e5-e063-6294a90aa4eaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-131-32Pyrithione Zinc370 mL in 1 BOTTLE, PLASTICSHAMPOO3701

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 4 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermoia Psoriasis Treatment Salicylic AcidSALICYLIC ACIDTreasurewise LLCfec62bf1-7423-4806-9ac9-1254d7eb62da2026-05-27WarningsExact identifier
application number: M032
5% Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.5278c9c2-4bce-fed4-e063-6394a90a7f332026-05-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.527902b1-2018-4546-e063-6394a90a70522026-05-23WarningsExact identifier
application number: M032
VeraRoot Minoxidil Topical SolutionVERAROOT MINOXIDIL TOPICAL SOLUTIONShenzhen Xinxin Yunhai Technology Co., Ltd.52794d53-43ba-98ea-e063-6394a90a80a92026-05-23WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc521c263e-d29c-2564-e063-6394a90a2e1d2026-05-18WarningsExact identifier
application number: M032
Matrix Biolage Scalp Sync AntidandruffPYRITHIONE ZINCL'Oreal USA Products Incea6fb9ff-8895-4754-9fd7-d24c235f01322026-05-15WarningsExact identifier
application number: M032
Simply Clean DandruffPYRITHIONE ZINCAldi, Inc6db037d4-c781-4cee-a4d5-52a93eccd55f2026-05-13Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCAldi, Incb27d1453-d825-43ac-8a44-d7a5015ab9772026-05-13Warnings, Adverse reactionsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCL'Oreal USA Products Incd6a704df-edd8-4960-a088-246519e2aecf2026-05-12WarningsExact identifier
application number: M032
Kopa Haiku Seborrheic Dermatitis Face CreamSALICYLIC ACID 0.5% AND ZINC PYRITHIONE 0.25%Trovina Co. Ltd483450d2-e38b-56ec-e063-6394a90acb5b2026-05-10WarningsExact identifier
application number: M032
Mens SportPYRITHIONE ZINCApollo Health and Beauty Care1d1203ea-9994-31bb-e063-6394a90a9ec82026-05-08WarningsExact identifier
application number: M032
Classic CleanSHAMPOOApollo Health and Beauty Carefa684d69-771a-d3d4-e053-6294a90a13442026-05-08WarningsExact identifier
application number: M032
CVS GoldSELENIUM SULFIDEApollo Health and Beauty Care1d12ca6a-2734-0534-e063-6294a90a27062026-05-08WarningsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCApollo Health and Beauty Care0a4ab6fa-bf74-fe6e-e063-6394a90aa6fc2026-05-08WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Total Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5126db42-4fd3-319e-e063-6394a90aab3f2026-05-06WarningsExact identifier
application number: M032
Follence MedicatedSALICYLIC ACIDCISNE GROUP LLC512abbb6-ea6a-70b1-e063-6294a90a2a7c2026-05-06WarningsExact identifier
application number: M032
WalgreensSALICYLIC ACIDWalgreensec1a09dc-7fb6-6d89-e053-2a95a90a48412026-05-05WarningsExact identifier
application number: M032
Follence MedicatedSALICYLIC ACIDGuangzhou Pallas Cosmetics Co.,Ltd.51178cb9-f83f-2459-e063-6394a90a3f1e2026-05-05WarningsExact identifier
application number: M032
Recuren Plus Balanced ScalpSALICYLIC ACIDREGENEREN PLUS LTD50c27b0f-9bf5-de9c-e063-6394a90af41a2026-05-04WarningsExact identifier
application number: M032
Mielle Lavender and Lychee Scalp MoisturizingPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company510212e9-1d12-3a0a-e063-6294a90a1d782026-05-04WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN4db2aaf4-5caf-d9e5-e063-6294a90aa4ea1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD4db2aaf4-5caf-d9e5-e063-6294a90aa4ea1
209884zinc pyrithione 1 % Medicated ConditionerSY4db2aaf4-5caf-d9e5-e063-6294a90aa4ea1
209884zinc pyrithione 1 % Medicated ShampooSY4db2aaf4-5caf-d9e5-e063-6294a90aa4ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-131-3211344013132370 mL in 1 BOTTLE, PLASTIC (11344-131-32) 370 ml2026-03-23NoNoCurrent