FDA.reportPublic FDA data

DermaZinc

Product NDC
35324-001
11-digit product format
353240001
Labeler code
35324
Product ID
35324-001_4388139e-9bb0-4c9c-e063-6394a90a4deb
Type
HUMAN OTC DRUG
Nonproprietary name
pyrithione zinc
Dosage form
CREAM
Route
TOPICAL
Labeler
WynnPharm Inc
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-29
Substance
PYRITHIONE ZINC
Active strength
.25 g/100g
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
DermaZinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC.25 g/100g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259549Internal RxNorm lookup
1306177Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e72e54ba-03fe-6748-e053-2a95a90a196fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35324-001-04DermaZinc114 g in 1 JARCREAM1144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35324-001DERMAZINC (PYRITHIONE ZINC) CREAM [WYNNPHARM INC]3Current NDC, Legacy NDC, 1 package rows20241122_e72e54ba-03fe-6748-e053-2a95a90a196f.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 1 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Classic Clean DandruffPYRITHIONE ZINCCARDINAL HEALTH 110, LLC. DBA LEADER5b22537d-d09c-5bd6-e063-6294a90a48ff2026-09-10WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cc726c2-3747-6dbf-e063-6294a90a789f2026-09-09WarningsExact identifier
application number: M032
Leader Maximum Strength Therapeutic DandruffSALICYLIC ACIDCARDINAL HEALTH 110, LLC. DBA LEADER5afb2260-5b50-de95-e063-6394a90a5a472026-09-08WarningsExact identifier
application number: M032
ANTI-DANDRUFFKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.5ac93feb-eb6d-7563-e063-6294a90ad2e02026-09-05WarningsExact identifier
application number: M032
Dr Marvel ANTI DANDRUFF SCALP SERUMSELENIUM SULFIDE SALICYLIC ACIDGuangzhou Liyan Cosmetics Technology Co., Ltd.5aaeddff-72f9-3687-e063-6394a90ae5dc2026-09-04WarningsExact identifier
application number: M032
Head and Shoulders Scalp Restore Nourishing ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5a834d00-cc79-1a8e-e063-6294a90ab2452026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Purify Clarifying Pre-ShampooSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a84c545-4570-b078-e063-6394a90a8c5a2026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Purify VolumizingSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a8627ec-cfd8-d0f6-e063-6394a90ab4882026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Soothe CoolingSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a87ed71-87e7-a7b7-e063-6294a90ac8972026-09-02WarningsExact identifier
application number: M032
Head and Shoulders Scalp Restore NourishingPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5a8a42d2-8610-1dfb-e063-6294a90abc7a2026-09-02WarningsExact identifier
application number: M032
Koi Beauty 5% Minoxidil Hair Growth Kit5% MINOXIDIL HAIR GROWTH KITBeijing Sea Heart International Science And Technology Co.,Ltd.3b34f263-1232-4bb9-e063-6294a90a494d2026-08-27WarningsExact identifier
application number: M032
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC9e235139-07a2-469a-8601-db69379ce3472026-08-24WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC634019c2-03a3-4fed-939e-6f9a50ddea7b2026-08-24WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b4f9e3-c241-6a70-e063-6294a90a364f2026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b52a52-dab0-87b5-e063-6294a90a05962026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b67ce0-3546-c18a-e063-6394a90ae50a2026-08-23WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.59a0a062-92d1-210a-e063-6394a90a9bf92026-08-22WarningsExact identifier
application number: M032
Ouai Anti-DandruffSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5990c45f-f653-b403-e063-6394a90a329d2026-08-21WarningsExact identifier
application number: M032
Dermatology Psoriasis CreamCOAL TARG.M.J Natural Products, Inc.96cc5455-f3b8-4ded-a158-5de209d7bf0d2026-08-21WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1306177DermaZinc 0.25 % Topical CreamPSNe72e54ba-03fe-6748-e053-2a95a90a196f4
259549zinc pyrithione 0.25 % Topical CreamPSNe72e54ba-03fe-6748-e053-2a95a90a196f4
1306177zinc pyrithione 2.5 MG/ML Topical Cream [Dermazinc]SBDe72e54ba-03fe-6748-e053-2a95a90a196f4
259549zinc pyrithione 2.5 MG/ML Topical CreamSCDe72e54ba-03fe-6748-e053-2a95a90a196f4
1306177Dermazinc 0.25 % Topical CreamSYe72e54ba-03fe-6748-e053-2a95a90a196f4
259549zinc pyrithione 0.25 % Topical CreamSYe72e54ba-03fe-6748-e053-2a95a90a196f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35324-001-0435324000104114 g in 1 JAR (35324-001-04) 114 g2022-08-290000-00-00NoNoCurrent