FDA.reportPublic FDA data

Nioxin PRO CLINICAL SCALP RECOVERY purifying

Product NDC
82157-011
11-digit product format
821570011
Labeler code
82157
Product ID
82157-011_44746d42-41d8-e499-e063-6394a90aac2d
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Wella Operations US LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-01
Substance
PYRITHIONE ZINC
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Nioxin PRO CLINICAL SCALP RECOVERY purifying
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209884Internal RxNorm lookup
1487080Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
316c61e9-7cdf-a548-e063-6294a90ab7c3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82157-011-20nioxin PRO CLINICAL SCALP RECOVERY200 mL in 1 BOTTLE, PLASTICSHAMPOO200 mL1 g in 100mL3
82157-011-10Nioxin PRO CLINICAL SCALP RECOVERY purifying1000 mL in 1 BOTTLE, PLASTICSHAMPOO10002
82157-011-20Nioxin PRO CLINICAL SCALP RECOVERY purifying200 mL in 1 BOTTLE, PLASTICSHAMPOO2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82157-011NIOXIN PRO CLINICAL SCALP RECOVERY (PYRITHIONE ZINC) KIT [WELLA OPERATIONS US LLC]2Current NDC20250406_31bf4f7f-8228-7433-e063-6394a90a2f5f.zip
82157-011NIOXIN PRO CLINICAL SCALP RECOVERY PURIFYING (PYRITHIONE ZINC) SHAMPOO [WELLA OPERATIONS US LLC]1Current NDC, 2 package rows20250406_316c61e9-7cdf-a548-e063-6294a90ab7c3.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 17 of 31 · 613 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders 2in1 Men Advanced Series Pure Sport Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7bbd2559-4aba-9f18-e053-2991aa0a152e2025-11-13WarningsExact identifier
application number: M032
Divine Dandrene 1%ZINC PYRITHIONEDS Healthcare Group, Inc.ab605699-4090-45a3-882f-44379fe2a82e2025-11-11WarningsExact identifier
application number: M032
Divine Dandrene 2%ZINC PYRITHIONEDS Healthcare Group, Inc.54b0a610-dd15-4064-9feb-4d30b5e522ad2025-11-11WarningsExact identifier
application number: M032
Dandrene Anti-Dandruff ConditionerZINC PYRITHIONEDS Healthcare Group, Inc.aed49bfe-e016-46ac-a025-81b47cc081472025-11-11WarningsExact identifier
application number: M032
Minoxidil hair growth serumMINOXIDIL HAIR GROWTH SERUMJiashen International Trade Limited26cc22be-30f6-03da-e063-6394a90aafe72025-11-09WarningsExact identifier
application number: M032
Sulfur 8 Kids Anti-DandruffPYRITHIONE ZINCJ. Strickland & Co.89f4ecc8-7a49-42cb-b85d-71c9299e67122025-11-07WarningsExact identifier
application number: M032
Sulfur 8 Aqua BluePYRITHIONE ZINCJ. Strickland & Co.cdcf3cea-4a5d-4b8b-b47d-3163f9837d162025-11-07WarningsExact identifier
application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff ControlPYRITHIONE ZINCJ. Strickland and Co.96b26da0-d0d7-77ed-e053-2995a90a7a782025-11-07WarningsExact identifier
application number: M032
Shailee Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd02a71ce4-baf5-4231-afd6-21ef0b22e9312025-11-05WarningsExact identifier
application number: M032
Sulfur 8 Kids Anti-Dandruff Hair and Scalp ConditionerSULFURJ. Strickland & Co.8e9da3fd-701e-4354-bb00-ecd4dab48fa32025-11-03WarningsExact identifier
application number: M032
Denorex Severe Flakes Medicated Anti DandruffPYRITHIONE ZINCNeoteric Cosmetics, Inc.41ad0d3a-0704-44c9-e063-6394a90ad40d2025-10-21WarningsExact identifier
application number: M032
Stay Minoxidil Hair Regrowth TreatmentMINOXIDIL 5%HALORIA INC.41b745d7-6947-ec24-e063-6294a90aa4672025-10-21WarningsExact identifier
application number: M032
DERMOSCRIBE SEBORRHEIC DERMATITISSULFUR, SALICYLIC ACID, HYDROCORTISONEDERMOSCRIBE PTY LTD2b6bf90b-5d42-4c08-afee-56e13122285e2025-10-17WarningsExact identifier
application number: M032
Shea MoistureAPPLE CIDER VINEGAR INSTANT SCALP REFRESH ANTI-DANDRUFF SPRAYConopco, Inc. d/b/a Unilever414ab8ec-165c-21f8-e063-6294a90adc4f2025-10-16WarningsExact identifier
application number: M032
Shea MoistureAPPLE CIDER VINEGAR ANTI-DANDRUFF LEAVE-INConopco, Inc. d/b/a Unilever414b7fd2-6a65-af39-e063-6394a90a00b82025-10-16WarningsExact identifier
application number: M032
Seacall Natural Cedarwood OilNATURAL CEDARWOOD OILGuangdong Quadrant Ecological Technology Co., Ltd.1f4ebe4d-6e93-378c-e063-6394a90aec952025-10-15WarningsExact identifier
application number: M032
RemedyDandruffShampooTreatmentACTIIV REMEDY DANDRUFF SHAMPOO TREATMENTNaturich Cosmetique Labs129fd043-6643-cc46-e063-6294a90a6eae2025-10-08WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company40464e2d-f738-33ec-e063-6394a90a02c22025-10-03WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Clinical Strength Cooling Itch ReliefSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company4046c345-e1ac-0ecc-e063-6294a90a59fa2025-10-03WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief SerumPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company402e2561-e309-46f2-e063-6394a90a4e582025-10-02WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593569NIOXIN 0.5 % Medicated ConditionerPSN31bf4f7f-8228-7433-e063-6394a90a2f5f3
1487080NIOXIN 1 % Medicated ShampooPSN31bf4f7f-8228-7433-e063-6394a90a2f5f3
1043014zinc pyrithione 0.5 % Medicated ConditionerPSN31bf4f7f-8228-7433-e063-6394a90a2f5f3
209884zinc pyrithione 1 % Medicated ShampooPSN31bf4f7f-8228-7433-e063-6394a90a2f5f3
1487080zinc pyrithione 10 MG/ML Medicated Shampoo [Nioxin]SBD31bf4f7f-8228-7433-e063-6394a90a2f5f3
1593569zinc pyrithione 5 MG/ML Medicated Shampoo [Nioxin]SBD31bf4f7f-8228-7433-e063-6394a90a2f5f3
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD31bf4f7f-8228-7433-e063-6394a90a2f5f3
1043014zinc pyrithione 5 MG/ML Medicated ShampooSCD31bf4f7f-8228-7433-e063-6394a90a2f5f3
1593569Nioxin 0.5 % Medicated ConditionerSY31bf4f7f-8228-7433-e063-6394a90a2f5f3
1593569Nioxin 0.5 % Medicated ShampooSY31bf4f7f-8228-7433-e063-6394a90a2f5f3
1487080Nioxin 1 % Medicated ShampooSY31bf4f7f-8228-7433-e063-6394a90a2f5f3
1487080Nioxin 10 MG/ML ConditionerSY31bf4f7f-8228-7433-e063-6394a90a2f5f3
1487080Nioxin 10 MG/ML Medicated ShampooSY31bf4f7f-8228-7433-e063-6394a90a2f5f3
1593569Nioxin 5 MG/ML Medicated ShampooSY31bf4f7f-8228-7433-e063-6394a90a2f5f3
1043014zinc pyrithione 0.5 % Medicated ShampooSY31bf4f7f-8228-7433-e063-6394a90a2f5f3
209884zinc pyrithione 1 % Medicated ConditionerSY31bf4f7f-8228-7433-e063-6394a90a2f5f3
209884zinc pyrithione 1 % Medicated ShampooSY31bf4f7f-8228-7433-e063-6394a90a2f5f3
1487080NIOXIN 1 % Medicated ShampooPSN316c61e9-7cdf-a548-e063-6294a90ab7c32
209884zinc pyrithione 1 % Medicated ShampooPSN316c61e9-7cdf-a548-e063-6294a90ab7c32
1487080zinc pyrithione 10 MG/ML Medicated Shampoo [Nioxin]SBD316c61e9-7cdf-a548-e063-6294a90ab7c32
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD316c61e9-7cdf-a548-e063-6294a90ab7c32
1487080Nioxin 1 % Medicated ShampooSY316c61e9-7cdf-a548-e063-6294a90ab7c32
1487080Nioxin 10 MG/ML ConditionerSY316c61e9-7cdf-a548-e063-6294a90ab7c32
1487080Nioxin 10 MG/ML Medicated ShampooSY316c61e9-7cdf-a548-e063-6294a90ab7c32
209884zinc pyrithione 1 % Medicated ConditionerSY316c61e9-7cdf-a548-e063-6294a90ab7c32
209884zinc pyrithione 1 % Medicated ShampooSY316c61e9-7cdf-a548-e063-6294a90ab7c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82157-011-10821570011101000 mL in 1 BOTTLE, PLASTIC (82157-011-10) 1000 ml2025-04-01NoNoCurrent
82157-011-2082157001120200 mL in 1 BOTTLE, PLASTIC (82157-011-20) 200 ml2025-04-01NoNoCurrent