FDA.reportPublic FDA data

Nioxin Scalp Recovery Soothing Serum

Product NDC
82157-005
11-digit product format
821570005
Labeler code
82157
Product ID
82157-005_eee20915-edb0-13a6-e053-2995a90aebd9
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
LOTION
Route
TOPICAL
Labeler
Wella Operations US LLC
Application
M032
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-12-01
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
0 g/100mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82157-005DDiscontinued by firm2026-10-15
excluded packagepackage82157-00582157-005-10DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82157-005NIOXIN SCALP RECOVERY ANTI-DANDRUFF SYSTEM (PYRITHIONE ZINC) KIT [WELLA OPERATIONS US LLC]3Legacy NDC20241220_e55a3a25-0fe9-f3ce-e053-2995a90a5cbb.zip
82157-005NIOXIN SCALP RECOVERY SOOTHING SERUM (PYRITHIONE ZINC) LOTION [WELLA OPERATIONS US LLC]3Legacy NDC20241220_e4f85007-12d7-b22d-e053-2995a90aa126.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 30 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Therapeutic Dandruff Original Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARWal-Mart Stores, Inc.78cabb38-9f9d-403d-b79c-ceedcea1812f2023-11-20WarningsExact identifier
application number: M032
Aloe Coal 01PYRITHIONE ZINCT. SPRUILL, LLC40a94657-6722-46b1-87ed-a15bf60ffc7a2023-11-11WarningsExact identifier
application number: M032
HAIRCARE Physicians RecommendedSALICYLIC ACIDLAWRENCE E SAMUELS MD INC095fcc1c-8f5b-47bd-a32a-7f5da5d162cd2023-11-11WarningsExact identifier
application number: M032
Home Health Psoriasis Medicated Scalp and Body WashSALICYLIC ACIDHome Healthd10dad0e-34e1-49d4-a17a-36dbdbd66eb62023-11-06WarningsExact identifier
application number: M032
Glovers Therapeutic CareSALICYLIC ACIDJ. Strickland and Co.bf101147-1408-4819-829a-6079f64483002023-11-05WarningsExact identifier
application number: M032
Sulfur 8 Medicated Dandruff with Salicylic AcidSALICYLIC ACIDJ. Strickland and Co.14f41263-9999-448d-a479-abf67fb3b27b2023-11-05WarningsExact identifier
application number: M032
Home Health Everclean AntidandruffSALICYLIC ACIDHome Health851ef329-f9be-4d50-87aa-b6c5eb3a2a892023-11-05WarningsExact identifier
application number: M032
Doo Gro Anti-Dandruff VitalizerSALICYLIC ACIDJ. Strickland & Co. DBA Nature's Protein, Inc.ad05695d-371d-4c38-8f78-b6736b505ab72023-10-31WarningsExact identifier
application number: M032
Doo Gro Anti-Dandruff VitalizerPYRITHIONE ZINCJ. Strickland & Co. DBA Nature's Protein, Inc.7366c6f8-4cc2-520e-e053-2991aa0a2cc82023-10-31WarningsExact identifier
application number: M032
Compound W Total Care Wart and Skin KitSALICYLIC ACIDHK Kolmar Canada, Incdef46762-990a-48b0-b702-15ece1dc541f2023-10-27WarningsExact identifier
application number: M032
Satinique Anti DandruffPYRITHIONE ZINCAccess Business Group LLCae71967e-110d-4fae-a966-8382ca62bc1f2023-10-23WarningsExact identifier
application number: M032
Glovers Anti-DandruffSULFUR, SALICYLIC ACIDJ. Strickland & Co.49fd4e03-736c-429a-8972-7302b732f8162023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Oil Moisturizer Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.abb85f88-78bb-4d84-9436-4616b31c63d12023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Anti-Dandruff BraidSALICYLIC ACIDJ. Strickland & Co.d240be47-8b86-4836-8407-c9ffe44628e82023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Light Moisturizer Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.8af5f208-f132-4e09-b353-ef12633ad3502023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Fresh Anti-Dandruff MoisturizingPYRITHIONE ZINCJ. Strickland & Co.93c7c97b-7cd2-4d70-b437-6c175c8bab902023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Fresh Anti-DandruffSALICYLIC ACIDJ. Strickland & Co.5acd1aab-3a6d-4d2c-8c80-271ab8dcac1a2023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Five Star Anti-Dandruff Hair GroomPYRITHIONE ZINCJ. Strickland & Co.bff46093-8186-4b2e-9363-03e67d04227a2023-10-21WarningsExact identifier
application number: M032
Sulfur 8 Fresh Anti-Dandruff Oil MoisturizingPYRITHIONE ZINCJ. Strickland & Co.9f1886c7-5a19-4706-83dc-828d7ed06b192023-10-21WarningsExact identifier
application number: M032
Glovers Dandruff Control Med., FloralSULFURJ. Strickland & Co.a1224e4a-e811-4415-a038-3933da43d8192023-10-21WarningsExact identifier
application number: M032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82157-005-1082157000510100 mL in 1 BOTTLE, PLASTIC (82157-005-10) 100 ml2022-12-010000-00-00NoNoCurrent