Pyrithione zinc

Product NDC
75712-470
11-digit product format
757120470
Labeler code
75712
Product ID
75712-470_4c0fa07b-b80f-095d-e063-6394a90a8d88
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Old East Main Co.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-25
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
f17154e2-1bcf-43f9-b201-e84d374a0591Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-470-32Pyrithione zinc370 mL in 1 BOTTLE, PLASTICSHAMPOO3704

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75712-470PYRITHIONE ZINC SHAMPOO [OLD EAST MAIN CO.]2Current NDC, 1 package rows20241004_f17154e2-1bcf-43f9-b201-e84d374a0591.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 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 ShampooPSNf17154e2-1bcf-43f9-b201-e84d374a05914
209884zinc pyrithione 10 MG/ML Medicated ShampooSCDf17154e2-1bcf-43f9-b201-e84d374a05914
209884zinc pyrithione 1 % Medicated ConditionerSYf17154e2-1bcf-43f9-b201-e84d374a05914
209884zinc pyrithione 1 % Medicated ShampooSYf17154e2-1bcf-43f9-b201-e84d374a05914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75712-470-3275712047032370 mL in 1 BOTTLE, PLASTIC (75712-470-32) 370 ml2023-09-25NoNoCurrent