FDA.reportPublic FDA data

Head and Shoulders

Product NDC
37000-079
Requested package NDC
37000-079-70
11-digit product format
370000079
Labeler code
37000
Product ID
37000-079_4ce92fce-6c16-8aa6-e063-6394a90af523
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-01
Substance
PYRITHIONE ZINC
Active strength
1 g/100mL
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 packagepackage37000-07937000-079-70DDiscontinued by firm2026-08-10

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Head and Shoulders
Brand name suffix
Itchy Scalp
Listing expiration
2027-12-31

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
1043244Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54df1acc-4265-494c-879e-c690184d7ae2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-079-01Head and ShouldersItchy Scalp700 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO70012
37000-079-01Head and ShouldersItchy Scalp2 in 1 CELLO PACKLOTION/SHAMPOO212
37000-079-37Head and ShouldersItchy Scalp370 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO37012
37000-079-40Head and ShouldersItchy Scalp400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO40012
37000-079-61Head and ShouldersItchy Scalp613 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO61312
37000-079-70Head and ShouldersItchy Scalp700 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO70012
37000-079-83Head and ShouldersItchy Scalp835 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO83512
37000-079-95Head and ShouldersItchy Scalp950 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO95012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ5HEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
Pyrithione ZincACTIVE MOIETYR953O2RHZ5HEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
cocamidopropyl betaineINACTIVE INGREDIENT5OCF3O11KXHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
eucalyptus globulus leafINACTIVE INGREDIENTS546YLW6E6HEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
glycol distearateINACTIVE INGREDIENT13W7MDN21WHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
magnesium carbonate hydroxideINACTIVE INGREDIENTYQO029V1L4HEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
methylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPNHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFAHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
sodium laureth-3 sulfateINACTIVE INGREDIENTBPV390UAP0HEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
sodium xylenesulfonateINACTIVE INGREDIENTG4LZF950URHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
WaterINACTIVE INGREDIENT059QF0KO0RHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
zinc carbonateINACTIVE INGREDIENTEQR32Y7H0MHEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-079HEAD AND SHOULDERS ITCHY SCALP (PYRITHIONE ZINC) LOTION/SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Current NDC, Legacy NDC, 8 package rows20241127_54df1acc-4265-494c-879e-c690184d7ae2.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 1 of 31 · 617 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast ReliefPYRITHIONE ZINCRida LLCd1e4dee7-5962-4ec1-ab99-9d547077b2f22026-08-05WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief TreatmentSALICYLIC ACIDRida LLC6226ce12-432f-402e-bda7-a5ca96f0b8382026-08-05WarningsExact identifier
application number: M032
JOHNSON FOAMMINOXIDILJOHNSON BIOPHARMACEUTICAL INC.1d44a75c-c940-680c-e063-6394a90a58392026-08-02WarningsExact identifier
application number: M032
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact identifier
application number: M032
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M032
Pureskin Seborrheic Dermatitis and Psoriasis CreamSEBORRHEIC DERMATITIS PSORIASIS CREAMBENLONG HALL LLC36086f7f-8536-417f-a302-37f78288489e2026-07-20WarningsExact identifier
application number: M032
5%MINOXIDIL TOPICAL FOAMMINOXIDILVeloce Trading Co., Limited56f87881-653f-17e6-e063-6294a90a67872026-07-19WarningsExact identifier
application number: M032
ProBliva Psoriasis Shampoo.SALICYLIC ACID 3%CAVTECH HOLDING LLC563e75f9-a1e2-2796-e063-6294a90aedb42026-07-10WarningsExact identifier
application number: M032
ProBliva Anti Dandruff Shampoo.SELENIUM SULFIDE 1%CAVTECH HOLDING LLC56022f6b-d7ba-1ccd-e063-6294a90a73102026-07-07WarningsExact identifier
application number: M032
Antifungal Psoriasis Shampoo.SALICYLIC ACID 2%Trovina Co. Ltd5512ac82-e3c5-37e6-e063-6294a90a92d62026-07-01WarningsExact identifier
application number: M032
Anti-fungalANTI-FUNGAL SHAMPOOShenzhen Chaoxiji Technology Co.,Ltd.555cb4fa-6f59-fa69-e063-6394a90a1db62026-06-28WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC55246263-7345-ba65-e063-6294a90ab1632026-06-26WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc552926da-0dfb-4248-e063-6294a90ab4a82026-06-26WarningsExact identifier
application number: M032
Dermoia Seborrheic Dermatitis Selenium SulfideSELENIUM SULFIDETREASUREWISE LLC04b8532e-44a7-4eaf-a46d-87611ec93c242026-06-23WarningsExact identifier
application number: M032
Dermgentle Seborrheic Scalp SerumPYRITHIONE ZINCDermgentle LLC54a0901a-404f-ea0e-e063-6294a90a6dc72026-06-19WarningsExact identifier
application number: M032
Silvagle Selenium Sulfide Anti DandruffShampooSELENIUM SULFIDEGUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD54885ae3-7e2f-7bd2-e063-6394a90a97fe2026-06-18WarningsExact identifier
application number: M032
Pharmlitalia Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd845a82f6-7d0e-416d-b5b0-bf788dca2f542026-06-18WarningsExact identifier
application number: M032
anti dandruff SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD5459e831-41e7-f1c7-e063-6394a90ae0982026-06-16WarningsExact identifier
application number: M032
ANTI DANDRUFF SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD545780f9-a202-95e9-e063-6394a90a982f2026-06-15WarningsExact identifier
application number: M032
Anti-DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.543a431f-21fb-df9e-e063-6394a90a6c362026-06-14WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043244head & shoulders 1 % Medicated ShampooPSN54df1acc-4265-494c-879e-c690184d7ae212
209884zinc pyrithione 1 % Medicated ShampooPSN54df1acc-4265-494c-879e-c690184d7ae212
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD54df1acc-4265-494c-879e-c690184d7ae212
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD54df1acc-4265-494c-879e-c690184d7ae212
1043244Head & Shoulders 1 % Medicated ShampooSY54df1acc-4265-494c-879e-c690184d7ae212
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY54df1acc-4265-494c-879e-c690184d7ae212
209884zinc pyrithione 1 % Medicated ConditionerSY54df1acc-4265-494c-879e-c690184d7ae212
209884zinc pyrithione 1 % Medicated ShampooSY54df1acc-4265-494c-879e-c690184d7ae212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-079-7037000007970700 mL in 1 BOTTLE, PLASTIC (37000-079-70) 700 ml2013-09-010000-00-00NoNoCurrent