FDA.reportPublic FDA data

Pyrithione Zinc

Product NDC
71440-001
11-digit product format
714400001
Labeler code
71440
Product ID
71440-001_df71459e-2e31-8b2e-e053-2a95a90a83a8
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Cosmetic Dermatology Research Institute, LLC.
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-03-07
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
2 g/237mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71440-001IInactivated by FDA2026-10-12
excluded packagepackage71440-00171440-001-08IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71440-001-08Pyrithione Zinc237 mL in 1 BOTTLESHAMPOO2376

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71440-001PYRITHIONE ZINC SHAMPOO [COSMETIC DERMATOLOGY RESEARCH INSTITUTE, LLC.]6Legacy NDC, 1 package rows20241115_503599c1-dff7-0847-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN503599c1-dff7-0847-e054-00144ff88e886
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD503599c1-dff7-0847-e054-00144ff88e886
209884zinc pyrithione 1 % Medicated ConditionerSY503599c1-dff7-0847-e054-00144ff88e886
209884zinc pyrithione 1 % Medicated ShampooSY503599c1-dff7-0847-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71440-001-0871440000108237 mL in 1 BOTTLE (71440-001-08) 237 ml2021-08-270000-00-00NoNoCurrent