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 28 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Anti-Dandruff Conditioner Coconut and Shea ButterPYRITHIONE ZINCRejoice International Inc.e69319c8-c49c-415b-a7ea-ec6e77fa625c2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Conditioner mint and eucalyptusPYRITHIONE ZINCRejoice International Inc.08330f44-45e2-47cb-bd2e-cef15ba61aee2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea ButterPYRITHIONE ZINCRejoice International Inc.7d9bf611-db24-4915-9b13-b7b36f47711f2024-02-28WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptusPYRITHIONE ZINCRejoice International Inc.b05742fe-692f-45a3-9de0-5f3f08642d782024-02-28WarningsExact identifier
application number: M032
XtraCare Dandruff Hair WashSALICYLIC ACIDRejoice International1902e6bb-e829-4b1a-b85a-1394913c77ca2024-02-28WarningsExact identifier
application number: M032
amazon basics maximum strength dandruff Anti-dandruffSELENIUM SULFIDEAMAZON.COM SERVICES LLC194e4c51-ff7b-4def-a71d-efa5dfca3efd2024-02-26WarningsExact identifier
application number: M032
Doo Gro Braids Twists Locs Dandruff Control MoisturizingSALICYLIC ACIDJ. Strickland and Co.116f4f0d-66c7-49dd-e063-6394a90ab2b52024-02-15WarningsExact identifier
application number: M032
amazon basics therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARAMAZON.COM SERVICES LLCada1be0c-53a7-443c-bc3c-f7a26b5f96a92024-02-05WarningsExact identifier
application number: M032
Equate Dry Scalp 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.6440fdd9-daa8-4f15-bdee-33724993bd7b2024-02-01WarningsExact identifier
application number: M032
Equate Everyday Clean Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.4c84a67a-1f43-4f40-a172-271de7e767852024-01-29WarningsExact identifier
application number: M032
Equate Everyday Clean 2 in 1 Dandruff Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.c85095f2-5dbd-4822-a83a-dc3641c4a3302024-01-29WarningsExact identifier
application number: M032
HydrocortisoneANTIPRURITIC (ANTI-ITCH)Dynarex Corporation81dff9df-6f7e-49f0-e053-2a91aa0af7e72024-01-23WarningsExact identifier
application number: M032
Walgreens Original T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWalgreen Company42cc63ab-6f79-4544-8529-7b8c36021b182024-01-22WarningsExact identifier
application number: M032
True plus Real Therapeutic T plus Plus Original Strength Tar Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGarcoa, Inc.1f4c23d5-ca00-4387-abc7-59d9ef4719772024-01-22WarningsExact identifier
application number: M032
Walgreens Extra Strength T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWalgreen Company7f681386-976c-40f4-8b18-97413989ab782024-01-22WarningsExact identifier
application number: M032
Prosoria MedicatedSELENIUM SULFIDENuvothera, Inc.44eaaeb0-1400-4697-85d0-e8c2282c1cba2024-01-11WarningsExact identifier
application number: M032
Prosoria ScalpSALICYLIC ACIDNuvothera, Inc.52a98715-3e57-4b86-b91e-0ce433dc22bd2024-01-10WarningsExact identifier
application number: M032
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.f94f4481-c58e-4555-9863-cbaa2c4cdd072024-01-10WarningsExact identifier
application number: M032
Equate Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.408d57e4-a707-4826-a04c-99517dc9b5af2024-01-04WarningsExact identifier
application number: M032
Equate Extra Strength Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.986ac1ab-c7c3-40df-b41b-6f26cce22a432024-01-04WarningsExact 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