FDA.reportPublic FDA data

ALEVAI - STEM CELL ANTI DANDRUFF

Product NDC
81457-020
11-digit product format
814570020
Labeler code
81457
Product ID
81457-020_e3c4b2e7-c511-c4c8-e053-2995a90a78ae
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
ALEVAI PRODUCTS LLC
Application
M032
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-11-12
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct81457-020IInactivated by FDA2026-10-20
excluded packagepackage81457-02081457-020-04IInactivated by FDA2026-10-20
excluded packagepackage81457-02081457-020-08IInactivated by FDA2026-10-20
excluded packagepackage81457-02081457-020-16IInactivated by FDA2026-10-20
excluded packagepackage81457-02081457-020-32IInactivated by FDA2026-10-20

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
81457-020-04ALEVAI - STEM CELL ANTI DANDRUFF96 g in 1 BOTTLESHAMPOO967
81457-020-08ALEVAI - STEM CELL ANTI DANDRUFF226 g in 1 BOTTLESHAMPOO2267
81457-020-16ALEVAI - STEM CELL ANTI DANDRUFF453 g in 1 BOTTLESHAMPOO4537
81457-020-32ALEVAI - STEM CELL ANTI DANDRUFF906 g in 1 BOTTLESHAMPOO9067

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81457-020ALEVAI - STEM CELL ANTI DANDRUFF (PYRITHIONE ZINC) SHAMPOO [ALEVAI PRODUCTS LLC]7Legacy NDC, 4 package rows20241124_d09b2fb8-c252-67b8-e053-2995a90a377a.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 19 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.383926b7-997b-af1e-e063-6394a90a506d2025-06-23WarningsExact identifier
application number: M032
Brickell Mens Products Relieving Anti-DandruffSALICYLIC ACIDBRICKELL BRANDS LLC7ba3b13b-cb78-4df8-8719-c88e556643b42025-06-16WarningsExact identifier
application number: M032
VENROCKPIROCTONE OLAMINE AND SALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.372feca7-f6f1-cd38-e063-6294a90a3bfe2025-06-12WarningsExact identifier
application number: M032
Neutrogena T/Sal TherapeuticSALICYLIC ACIDKenvue Brands LLC54707f0f-6025-4dc3-8be8-7a38bb1363b82025-06-05WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SAaae04d08-9d0c-43bd-89c2-741884de3bea2025-06-04WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDL'Oreal USA Products Incbcffd505-82bd-45ce-9ad0-64a9e63f62b52025-06-04WarningsExact identifier
application number: M032
UCHOIZE S2 Balance Anti-DandruffUCHOIZE S2 BALANCE ANTI-DANDRUFF SHAMPOODreamwise International Corp36a5efa8-0617-868d-e063-6394a90a17052025-06-03WarningsExact identifier
application number: M032
DermaD ATOPIC DERMATITIS TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.d872a4ee-554e-4bca-acb1-3bbf57dc690b2025-05-29WarningsExact identifier
application number: M032
DermaD JOCK ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.c8c0449c-11f9-4434-a91c-b690d67808202025-05-29WarningsExact identifier
application number: M032
DermaD Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.e52c647b-8cdc-4023-af22-fbfb84ea0ada2025-05-27WarningsExact identifier
application number: M032
DermaER Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.f62e6c5e-6e80-4b75-a0b1-c893224d9ce42025-05-27WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince71e87ba-2a62-44f3-e053-2995a90a8b112025-05-25WarningsExact identifier
application number: M032
Tagrid ANTI FUNGALZINC PYRITHIONE,SALICYLIC ACIDTAGRID LLC3376b104-1f07-fab3-e063-6394a90a0ca42025-05-22WarningsExact identifier
application number: M032
Coal TarCOAL TARNopsor USA Distribution Co., Inc.407bd007-bec6-2864-e054-00144ff88e882025-05-05WarningsExact identifier
application number: M032
AntiDandruffShampoo365 ANTI DANDRUFF SHAMPOOWhole Foods Market, Inc.b9bc6bbb-31c5-427e-e053-2995a90a5f172025-04-29WarningsExact identifier
application number: M032
AntiDandruffShampooConditioner365 ANTI DANDRUFF SHAMPOO CONDITIONER 2 IN 1Whole Foods Market, Inc.c3f5b5fb-acb0-a904-e053-2995a90a56232025-04-29WarningsExact identifier
application number: M032
UTTSE Anti Fungal Shampoo.ANTI FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.33bebbe9-e0ab-2f7d-e063-6294a90add4e2025-04-27WarningsExact identifier
application number: M032
Psalmonica Hair Growth SerumMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.3380fe6d-e057-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3344c97b-8767-3f87-e063-6394a90a4f5d2025-04-21WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3346e2c5-af28-74ad-e063-6394a90abbab2025-04-21WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244458zinc pyrithione 2 % Medicated ShampooPSNd09b2fb8-c252-67b8-e053-2995a90a377a7
244458zinc pyrithione 20 MG/ML Medicated ShampooSCDd09b2fb8-c252-67b8-e053-2995a90a377a7
244458zinc pyrithione 2 % Medicated ShampooSYd09b2fb8-c252-67b8-e053-2995a90a377a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81457-020-048145700200496 g in 1 BOTTLE (81457-020-04) 96 g2022-06-170000-00-00NoNoCurrent
81457-020-0881457002008226 g in 1 BOTTLE (81457-020-08) 226 g2021-11-120000-00-00NoNoCurrent
81457-020-1681457002016453 g in 1 BOTTLE (81457-020-16) 453 g2021-11-120000-00-00NoNoCurrent
81457-020-3281457002032906 g in 1 BOTTLE (81457-020-32) 906 g2022-06-170000-00-00NoNoCurrent