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 firm2026-10-12
excluded packagepackage82157-00582157-005-10DDiscontinued by firm2026-10-12

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 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

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