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 31 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfur 8 Light Anti-Dandruff Hair and Scalp ConditionerSULFURJ. Strickland & Co.d8f9afe8-bc44-41be-806b-b77d2def0fb02023-10-21WarningsExact identifier
application number: M032
Glovers Dandruff Control Medicine, RegularSULFURJ. Strickland & Co.18700036-11ec-4370-bcc6-b9e2c732e7d92023-10-21WarningsExact identifier
application number: M032
Glovers Medicated Anti-Dandruff ScalpSALICYLIC ACIDJ. Strickland & Co.bdf40a16-7b40-497e-939d-366cbe62b5552023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Original Anti-Dandruff Hair and Scalp ConditionerSULFURJ. Strickland & Co.eb1d6e9e-e7fd-478e-80c0-3a3f529682d72023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Loc Twist and Braid ScalpSALICYLIC ACIDJ. Strickland & Co.1aee59aa-ed8e-4f95-be99-63ce0814c03c2023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Fresh Anti-Dandruff Hair and Scalp ConditionerSALICYLIC ACIDJ. Strickland & Co.27b6276a-eaa0-4fb7-996c-53e8c28680912023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff ControlSALICYLIC ACIDJ. Strickland and Co.961ffab9-4e1b-83f3-e053-2a95a90af5fe2023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff Control Leave-In Soothing TreatmentSALICYLIC ACIDJ. Strickland and Co.96b24a6f-3d6e-6d60-e053-2a95a90a83302023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff Control Scalp Oil SerumSULFURJ. Strickland and Co.96b249a2-3f50-1ab8-e053-2995a90a56ed2023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff Control Scalp Butter CreamSULFUR, SALICYLIC ACIDJ. Strickland and Co.96b26d20-d4d8-1bc3-e053-2995a90afec02023-10-21WarningsExact identifier
application number: M032
Glovers Clinical Care Seborrheic Dermatitis AntidandruffPYRITHIONE ZINCJ. Strickland and Co.fef5701f-c5c7-4932-9a1c-42532e3910a52023-10-21WarningsExact identifier
application number: M032
Topco AssociatesSELENIUM SULFIDETopco Associatesecf87660-f552-1f6b-e053-2a95a90a24862023-05-04WarningsExact identifier
application number: M032
Careone Medicated DandruffSELENIUM SULFIDERetail Business Services, LLCcb05b9c6-c1bb-b210-e053-2a95a90afaea2021-08-26WarningsExact identifier
application number: M032
GoodSense Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-DandruffSELENIUM SULFIDEGOODSENSE21291e29-57ab-4761-8e8c-eef43ca65b242020-06-30WarningsExact identifier
application number: M032
ZolidynePYRITHIONE ZINCTopiderm, Inc.6d5eaecc-a3a1-4739-ae5b-66df4a15cd212019-11-20WarningsExact 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