Dandruff

Product NDC
41163-253
11-digit product format
411630253
Labeler code
41163
Product ID
41163-253_4b06137a-5bb6-557c-e063-6294a90a560b
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-21
Substance
PYRITHIONE ZINC
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-25341163-253-15DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41163-25341163-253-15DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41163-25341163-253-15DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
Dandruff
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC10 mg/mL

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77b2e0da-a6d7-42b5-92af-4e7979817b78Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-253-15Dandruff420 mL in 1 BOTTLE, PLASTICSHAMPOO42017
41163-253-32Dandruff370 mL in 1 BOTTLE, PLASTICSHAMPOO37017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5DANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
AMODIMETHICONE (800 CST)INACTIVE INGREDIENT363Z2T48P7DANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)INACTIVE INGREDIENTB16G315W7ADANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
MAGNESIUM CARBONATE HYDROXIDEINACTIVE INGREDIENTYQO029V1L4DANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFADANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0DANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950URDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
waterINACTIVE INGREDIENT059QF0KO0RDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1
ZINC CARBONATEINACTIVE INGREDIENTEQR32Y7H0MDANDRUFF (PYRITHIONE ZINC) SHAMPOO [SUPERVALU INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-253DANDRUFF (PYRITHIONE ZINC) SHAMPOO [UNITED NATURAL FOODS, INC. DBA UNFI]15Current NDC, Legacy NDC, 2 package rows20240915_77b2e0da-a6d7-42b5-92af-4e7979817b78.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 20 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Structure of Skin Soothing Anti-DandruffPYRITHIONE ZINCSTRUCTURE OF SKIN LLC3311fa83-a06b-b379-e063-6394a90ae2692025-04-18WarningsExact identifier
application number: M032
LILIVERA Hair Regrowth KitMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.330602da-ec17-5a35-e063-6394a90a741b2025-04-17WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company3272a482-3813-63e4-e063-6394a90a43eb2025-04-10WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse for normal hairPYRITHIONE ZINCRejoice International Inc.b90e574c-933c-4f86-aadc-567ffbe6ea042025-04-09WarningsExact identifier
application number: M032
XtraCare Anti-Dandruff Hair Cleanse for sensitive hairPYRITHIONE ZINCRejoice International Inc.979394c2-5681-44c8-a43c-bf3a392bd0c12025-04-09WarningsExact identifier
application number: M032
LEAHUE MADHUCA TONICSALICYLIC ACIDBio-interchange Co.31ee4645-0f64-f7a0-e063-6394a90a17362025-04-04WarningsExact identifier
application number: M032
LEAHUE MADHUCASALICYLIC ACIDBio-interchange Co.81470dfe-f063-9d16-e053-2a91aa0a18292025-04-04WarningsExact identifier
application number: M032
Kenkoderm Psoriasis MoisturizingSALICYLIC ACIDNexgel,Inc.31ce20a2-95ae-e424-e063-6394a90af18a2025-04-01WarningsExact identifier
application number: M032
Kenkoderm PsoriasisSALICYLIC ACIDNexgel,Inc.31cf90e5-0f21-903d-e063-6394a90a075d2025-04-01WarningsExact identifier
application number: M032
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serumPYRITHIONE ZINCThe Wella Corporation31af9365-e1a3-7203-e063-6294a90a8ade2025-03-31WarningsExact identifier
application number: M032
Listarfe Anti-Dandruff Shampoo.ANTI-DANDRUFF SHAMPOOGuangzhou Zanming Trading Co., Ltd.3163eee0-379f-1f88-e063-6294a90a58ce2025-03-28WarningsExact identifier
application number: M032
anti dandruff SHAMPOOSPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD31392f0f-a6c4-1cfb-e063-6294a90a4d362025-03-26WarningsExact identifier
application number: M032
anti dandruff SHAMPOOSPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD313716f7-6dd2-e1c5-e063-6394a90a9de32025-03-25WarningsExact identifier
application number: M032
CeraVe Anti Dandruff HydratingPYRITHIONE ZINCL'Oreal USA Products Inc422e743b-fd77-40ed-8c5d-7f05112a447f2025-03-24WarningsExact identifier
application number: M032
Scalp RevivalSALICYLIC ACID 3%Beccair, LLC0a77e90e-a33a-43f3-80a0-a16a6902a7352025-03-21WarningsExact identifier
application number: M032
Gold Bond Psoriasis Relief Medicated Multi-SymptomSALICYLIC ACIDChattem, Inc.e8479bbc-5f49-41f2-851e-a935435166392025-03-19WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINCRejoice International Corp.308554c2-938b-f0b5-e063-6394a90a5bfa2025-03-17WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINCRejoice International Corp.3086d31e-54ef-9c0f-e063-6394a90abdff2025-03-17WarningsExact identifier
application number: M032
SA Scalp TherapySA SCALPMilbar Laboratories304db1ab-acd7-43d5-e063-6294a90aeec22025-03-14WarningsExact identifier
application number: M032
Neutrogena Scalp Therapy Anti-Dandruff Itchy ScalpSALICYLIC ACIDKenvue Brands LLCca4c0d63-50b3-169f-e053-2a95a90acbcd2025-03-10WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN77b2e0da-a6d7-42b5-92af-4e7979817b7817
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD77b2e0da-a6d7-42b5-92af-4e7979817b7817
209884zinc pyrithione 1 % Medicated ConditionerSY77b2e0da-a6d7-42b5-92af-4e7979817b7817
209884zinc pyrithione 1 % Medicated ShampooSY77b2e0da-a6d7-42b5-92af-4e7979817b7817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-253-1541163025315420 mL in 1 BOTTLE, PLASTIC (41163-253-15) 420 ml2015-01-210000-00-00NoNoCurrent
41163-253-3241163025332370 mL in 1 BOTTLE, PLASTIC (41163-253-32) 370 ml2023-11-01NoNoCurrent