FDA.reportPublic FDA data

Treatment

Product NDC
73528-400
Requested package NDC
73528-400-03
11-digit product format
735280400
Labeler code
73528
Product ID
73528-400_eacafe04-8ce9-5069-e053-2995a90a46a1
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Pyrithione
Dosage form
CREAM
Route
TOPICAL
Labeler
Zero Flakes Given, LLC.
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-02-01
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage73528-40073528-400-03DDiscontinued 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.]7Legacy NDC, 4 package rows20250128_984816e3-3096-44c6-e053-2995a90af1aa.zip

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
73528-400-03735280400035 mL in 1 PACKET (73528-400-03) 5 ml2020-02-010000-00-00YesNoCurrent