Dandruff

Product NDC
76162-353
11-digit product format
761620353
Labeler code
76162
Product ID
76162-353_4ab83628-a6a6-c90d-e063-6394a90a1f28
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-25
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
Dandruff
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
a0f2c58b-bb17-42a3-bd90-be771f60ef20Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-353-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO3704

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-353DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]2Current NDC, 1 package rows20241027_a0f2c58b-bb17-42a3-bd90-be771f60ef20.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 2 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
apgwgzminoxidil2%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd5957c990-e274-6278-e063-6394a90af2b72026-08-18WarningsExact identifier
application number: M032
EVERYDAY CLEAN DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC3983b688-28ae-462e-8686-6cf2f2c1cca42026-08-18WarningsExact identifier
application number: M032
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.378311aa-95f7-4c69-bc00-e688468262bd2026-08-18WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC496e178b-e29b-071e-e063-6394a90aa0182026-08-13WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis shampoo.SALICYLIC ACID 3%RoyceDerm LLC4995ce33-e231-8f86-e063-6394a90af4862026-08-13WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast ReliefPYRITHIONE ZINCRida LLCd1e4dee7-5962-4ec1-ab99-9d547077b2f22026-08-05WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief TreatmentSALICYLIC ACIDRida LLC6226ce12-432f-402e-bda7-a5ca96f0b8382026-08-05WarningsExact identifier
application number: M032
JOHNSON FOAMMINOXIDILJOHNSON BIOPHARMACEUTICAL INC.1d44a75c-c940-680c-e063-6394a90a58392026-08-02WarningsExact identifier
application number: M032
EVERYDAY CLEAN DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a03d4bb-72e6-cc9f-e063-6394a90ae19f2026-08-01WarningsExact identifier
application number: M032
TEA TREE Oil DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a0505a6-77ca-c56e-e063-6394a90aea6f2026-08-01WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a0521cd-2b9e-e02c-e063-6394a90a5f022026-08-01WarningsExact identifier
application number: M032
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a054179-b0d7-3a0f-e063-6294a90a62092026-08-01WarningsExact identifier
application number: M032
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact identifier
application number: M032
RoyceDerm Psoriasis Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC57425b1a-4cf3-b133-e063-6394a90a84f52026-07-23WarningsExact identifier
application number: M032
RoyceDerm Psoriasis Scalp .Shampoo.SALICYLIC ACID 3%RoyceDerm LLC5743f813-57f7-f544-e063-6294a90ad3b82026-07-23WarningsExact identifier
application number: M032
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M032
Pureskin Seborrheic Dermatitis and Psoriasis CreamSEBORRHEIC DERMATITIS PSORIASIS CREAMBENLONG HALL LLC36086f7f-8536-417f-a302-37f78288489e2026-07-20WarningsExact identifier
application number: M032
5%MINOXIDIL TOPICAL FOAMMINOXIDILVeloce Trading Co., Limited56f87881-653f-17e6-e063-6294a90a67872026-07-19WarningsExact identifier
application number: M032
ProBliva Psoriasis Shampoo.SALICYLIC ACID 3%CAVTECH HOLDING LLC563e75f9-a1e2-2796-e063-6294a90aedb42026-07-10WarningsExact identifier
application number: M032
ProBliva Anti Dandruff Shampoo.SELENIUM SULFIDE 1%CAVTECH HOLDING LLC56022f6b-d7ba-1ccd-e063-6294a90a73102026-07-07WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSNa0f2c58b-bb17-42a3-bd90-be771f60ef204
209884zinc pyrithione 10 MG/ML Medicated ShampooSCDa0f2c58b-bb17-42a3-bd90-be771f60ef204
209884zinc pyrithione 1 % Medicated ConditionerSYa0f2c58b-bb17-42a3-bd90-be771f60ef204
209884zinc pyrithione 1 % Medicated ShampooSYa0f2c58b-bb17-42a3-bd90-be771f60ef204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-353-3276162035332370 mL in 1 BOTTLE, PLASTIC (76162-353-32) 370 ml2024-10-25NoNoCurrent