FDA.reportPublic FDA data

Pyrithione Zinc

Product NDC
81457-002
Requested package NDC
81457-002-16
11-digit product format
814570002
Labeler code
81457
Product ID
81457-002_e1a8e759-78bf-3efe-e053-2995a90a39d7
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
CREAM
Route
TOPICAL
Labeler
ALEVAI PRODUCTS LLC
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-11-16
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
2 g/100g
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 packagepackage81457-00281457-002-16IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
81457-002-0481457-002-04 81457-002-08 81457-002-16 81457-002-32
81457-002-0881457-002-04 81457-002-08 81457-002-16 81457-002-32
81457-002-1681457-002-04 81457-002-08 81457-002-16 81457-002-32
81457-002-3281457-002-04 81457-002-08 81457-002-16 81457-002-32

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81457-002-04ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER100 mL in 1 BOTTLELOTION1006
81457-002-08ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER236 mL in 1 BOTTLELOTION2366
81457-002-16ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER473 mL in 1 BOTTLELOTION4736
81457-002-32ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER946 mL in 1 BOTTLELOTION9466

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81457-002ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER (PYRITHIONE ZINC) LOTION [ALEVAI PRODUCTS LLC]6Legacy NDC, 4 package rows20230202_d0eebc4c-5558-3332-e053-2995a90a5e96.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81457-002-1681457000216453 g in 1 BOTTLE (81457-002-16) 453 g2021-11-160000-00-00NoNoCurrent