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 15 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty Anti-DandruffPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyd21cbfda-17de-b17c-e053-2995a90a33992025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Scalp RestorePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyecfd66a4-81f4-3463-e053-2a95a90a18b12025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Classic Clean with Vitamin EPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyecfde5bc-6100-d00c-e053-2995a90ac5dc2025-12-18WarningsExact identifier
application number: M032
Royal Oils by Head and Shoulders Scalp Care Dual PackPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company1aa02661-4381-4f01-e063-6294a90aec622025-12-18WarningsExact identifier
application number: M032
AVEYA BIOTIN HAIR GROWTHBIOTINGuangdong Aimu Biological Technology Co., Ltd460fff55-728a-9c3a-e063-6394a90a31882025-12-16WarningsExact identifier
application number: M032
Head and Shoulders Men Advanced Series Refreshing MentholPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7c4dacd2-d6aa-24c2-e053-2a91aa0a8c142025-12-16WarningsExact identifier
application number: M032
Head and Shoulders Coconut DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7cc1500e-b278-140a-e053-2991aa0ae6f22025-12-16WarningsExact identifier
application number: M032
Head and Shoulders Coconut KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company9029d795-12f3-7048-e053-2a95a90a21852025-12-16WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dandruff Defense Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb69c4d1f-379f-be92-e053-2995a90ab7ad2025-12-16WarningsExact identifier
application number: M032
MOISTURIZING DANDRUFF 1% Pyrithione ZincPYRITHIONE ZINCBentley Laboratories, LLCc38b3a45-87f4-4121-8ae6-0a20f7c16c722025-12-15WarningsExact identifier
application number: M032
PS-2896 Hydrocortisone Cream 1%, 0.9gPS-2896 HYDROCORTISONE CREAM 1%, 0.9GProStat First Aid LLC0074e7bf-8c62-a5a7-e063-6394a90a63fc2025-12-15WarningsExact identifier
application number: M032
Hydrocortisone 1%HYDROCORTISONE 1%ProStat First Aid LLCf707bda4-074a-6406-e053-6394a90a7ae12025-12-15WarningsExact identifier
application number: M032
Hydrocortisone Cream 1%HYDROCORTISONE CREAM 1%Front Line Safety0f4ede34-7e70-789e-e063-6394a90a72a42025-12-15WarningsExact identifier
application number: M032
Dermgentle Seborrheic Face CreamPYRITHIONE ZINCDermgentle LLC45232668-6953-80a0-e063-6294a90a6e4b2025-12-12WarningsExact identifier
application number: M032
Kadason MedicatedSALICYLIC ACIDYs Pharma Inc.f425408c-95b1-409f-b64f-2e9f2f3310a02025-12-10WarningsExact identifier
application number: M032
Zinc PyrithioneZINC PYRITHIONEHarry's Inc.a6fdb13b-7943-3ae9-e053-2995a90a9db52025-12-08WarningsExact identifier
application number: M032
Walgreens Dandruff Conditioner 2 in 1 Itchy Scalp Anti-dandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INCbf7b2339-20a4-4bab-b82f-6e28ff5187cb2025-12-08WarningsExact identifier
application number: M032
therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGOODSENSE72ab0e6b-72a5-4e8a-af44-963251b0641f2025-12-08WarningsExact identifier
application number: M032
Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC5ccd409b-a81f-41bc-b986-bc7c0cc643fd2025-12-08WarningsExact identifier
application number: M032
Gold Bond Psoriasis Relief Medicated Multi-SymptomSALICYLIC ACIDGold Bond Co LLC5949a2e4-9169-4fca-aabb-b18dd1bc298b2025-12-04WarningsExact 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