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 FDA2026-10-16
excluded packagepackage81457-02081457-020-04IInactivated by FDA2026-10-16
excluded packagepackage81457-02081457-020-08IInactivated by FDA2026-10-16
excluded packagepackage81457-02081457-020-16IInactivated by FDA2026-10-16
excluded packagepackage81457-02081457-020-32IInactivated by FDA2026-10-16

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 20 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Structure of Skin Soothing Anti-DandruffPYRITHIONE ZINCSTRUCTURE OF SKIN LLC3311fa83-a06b-b379-e063-6394a90ae2692025-04-18WarningsExact identifier
application number: M032
LILIVERA Hair Regrowth KitMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.330602da-ec17-5a35-e063-6394a90a741b2025-04-17WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company3272a482-3813-63e4-e063-6394a90a43eb2025-04-10WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse for normal hairPYRITHIONE ZINCRejoice International Inc.b90e574c-933c-4f86-aadc-567ffbe6ea042025-04-09WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse for sensitive hairPYRITHIONE ZINCRejoice International Inc.979394c2-5681-44c8-a43c-bf3a392bd0c12025-04-09WarningsExact identifier
application number: M032
LEAHUE MADHUCA TONICSALICYLIC ACIDBio-interchange Co.31ee4645-0f64-f7a0-e063-6394a90a17362025-04-04WarningsExact identifier
application number: M032
LEAHUE MADHUCASALICYLIC ACIDBio-interchange Co.81470dfe-f063-9d16-e053-2a91aa0a18292025-04-04WarningsExact identifier
application number: M032
Kenkoderm Psoriasis MoisturizingSALICYLIC ACIDNexgel,Inc.31ce20a2-95ae-e424-e063-6394a90af18a2025-04-01WarningsExact identifier
application number: M032
Kenkoderm PsoriasisSALICYLIC ACIDNexgel,Inc.31cf90e5-0f21-903d-e063-6394a90a075d2025-04-01WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serumPYRITHIONE ZINCThe Wella Corporation31af9365-e1a3-7203-e063-6294a90a8ade2025-03-31WarningsExact identifier
application number: M032
Listarfe Anti-Dandruff Shampoo.ANTI-DANDRUFF SHAMPOOGuangzhou Zanming Trading Co., Ltd.3163eee0-379f-1f88-e063-6294a90a58ce2025-03-28WarningsExact identifier
application number: M032
anti dandruff SHAMPOOSPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD31392f0f-a6c4-1cfb-e063-6294a90a4d362025-03-26WarningsExact identifier
application number: M032
anti dandruff SHAMPOOSPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD313716f7-6dd2-e1c5-e063-6394a90a9de32025-03-25WarningsExact identifier
application number: M032
CeraVe Anti Dandruff HydratingPYRITHIONE ZINCL'Oreal USA Products Inc422e743b-fd77-40ed-8c5d-7f05112a447f2025-03-24WarningsExact identifier
application number: M032
Scalp RevivalSALICYLIC ACID 3%Beccair, LLC0a77e90e-a33a-43f3-80a0-a16a6902a7352025-03-21WarningsExact identifier
application number: M032
Gold Bond Psoriasis Relief Medicated Multi-SymptomSALICYLIC ACIDChattem, Inc.e8479bbc-5f49-41f2-851e-a935435166392025-03-19WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINCRejoice International Corp.308554c2-938b-f0b5-e063-6394a90a5bfa2025-03-17WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINCRejoice International Corp.3086d31e-54ef-9c0f-e063-6394a90abdff2025-03-17WarningsExact identifier
application number: M032
SA Scalp TherapySA SCALPMilbar Laboratories304db1ab-acd7-43d5-e063-6294a90aeec22025-03-14WarningsExact identifier
application number: M032
Neutrogena Scalp Therapy Anti-Dandruff Itchy ScalpSALICYLIC ACIDKenvue Brands LLCca4c0d63-50b3-169f-e053-2a95a90acbcd2025-03-10WarningsExact 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