FDA.reportPublic FDA data

Treatment

Product NDC
73528-400
11-digit product format
735280400
Labeler code
73528
Product ID
73528-400_4f97b88e-81fc-99c5-e063-6294a90abccb
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Pyrithione
Dosage form
CREAM
Route
TOPICAL
Labeler
Zero Flakes Given, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-01
Substance
PYRITHIONE ZINC
Active strength
.125 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73528-400DDiscontinued by firm2026-09-14
excluded packagepackage73528-40073528-400-01DDiscontinued by firm2026-09-14
excluded packagepackage73528-40073528-400-02DDiscontinued by firm2026-09-14
excluded packagepackage73528-40073528-400-03DDiscontinued by firm2026-09-14
excluded packagepackage73528-40073528-400-04DDiscontinued by firm2026-09-14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0fbf7978-a66d-d22e-cf47-78546f9f9c42Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73528-400-01Treatment100 mL in 1 TUBECREAM1009
73528-400-02Treatment30 mL in 1 TUBECREAM309
73528-400-03Treatment5 mL in 1 PACKETCREAM59
73528-400-04Treatment60 mL in 1 TUBECREAM609

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73528-400TREATMENT (ZINC PYRITHIONE) CREAM [ZERO FLAKES GIVEN, LLC.]7Current NDC, Legacy NDC, 4 package rows20250128_984816e3-3096-44c6-e053-2995a90af1aa.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 · 634 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
2275631zinc pyrithione 0.125 % Topical CreamPSN984816e3-3096-44c6-e053-2995a90af1aa9
2275631zinc pyrithione 1.25 MG/ML Topical CreamSCD984816e3-3096-44c6-e053-2995a90af1aa9
2275631zinc pyrithione 0.125 % Topical CreamSY984816e3-3096-44c6-e053-2995a90af1aa9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73528-400-0173528040001100 mL in 1 TUBE (73528-400-01) 100 ml2020-02-010000-00-00NoNoCurrent
73528-400-027352804000230 mL in 1 TUBE (73528-400-02) 30 ml2020-02-010000-00-00NoNoCurrent
73528-400-03735280400035 mL in 1 PACKET (73528-400-03) 5 ml2020-02-010000-00-00YesNoCurrent
73528-400-047352804000460 mL in 1 TUBE (73528-400-04) 60 ml2025-01-01NoNoHistorical