FDA.reportPublic FDA data

Head and Shoulders Clinical Strength Dandruff Defense Sensitive Scalp

Product NDC
69423-642
11-digit product format
694230642
Labeler code
69423
Product ID
69423-642_eedc5d19-3921-3415-e053-2995a90ada7a
Type
HUMAN OTC DRUG
Nonproprietary name
Selenium Sulfide
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M032
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-04-22
Marketing end
0000-00-00
Substance
SELENIUM SULFIDE
Active strength
1 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 productproduct69423-642DDiscontinued by firm2026-10-15
excluded packagepackage69423-64269423-642-40DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-642-40Head and Shoulders Clinical Strength Dandruff Defense Sensitive Scalp400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO4004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-642HEAD AND SHOULDERS CLINICAL STRENGTH DANDRUFF DEFENSE SENSITIVE SCALP (SELENIUM SULFIDE) LOTION/SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3Legacy NDC, 1 package rows20241030_eedc5e57-8047-eab7-e053-2a95a90a2e2a.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 23 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaharmony Face and BodyPYRITHIONE ZINCD3 Development, Inc.bd72b53c-b22c-40d0-e053-2995a90af9c12024-12-20WarningsExact identifier
application number: M032
Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.637851c6-ff4a-8bbc-e053-2991aa0a963c2024-12-20WarningsExact identifier
application number: M032
Dermaharmony Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.cb442483-b735-01a0-e053-2995a90aaff52024-12-20WarningsExact identifier
application number: M032
Dermaharmony Pyrithione Zinc with Shea ButterPYRITHIONE ZINCD3 Development, Inc.dc7ba02c-bdbd-5136-e053-2995a90ac5452024-12-20WarningsExact identifier
application number: M032
Dermaharmony Tea Tree BarPYRITHIONE ZINCD3 Development, Inc.e9d5eb14-1840-ae21-e053-2a95a90aa3212024-12-20WarningsExact identifier
application number: M032
Dermaharmony Unscented BarPYRITHIONE ZINCD3 Development, Inc.e9d66c9c-5fb1-0a90-e053-2a95a90ab7a42024-12-20WarningsExact identifier
application number: M032
BYE-BYE CRADLE CAPPYRITHIONE ZINCTubby Toddf4398ad2-7da5-aff0-e053-2995a90ae2662024-12-12WarningsExact identifier
application number: M032
NATURALTECH PURIFYING ANTI-DANDRUFFPYRITHIONE ZINCDavines S.p.A.1f7e0265-0543-4ef9-addf-4d514d0eedfe2024-12-11WarningsExact identifier
application number: M032
NATURALTECH PURIFYING ANTI-DANDRUFFSELENIUM SULFIDEDavines S.p.A.369a24fd-3882-4fad-b57a-45806090aff12024-12-11WarningsExact identifier
application number: M032
Skin Renewing CreamSALICYLIC ACIDAllure Labsb5ea8f33-8f18-7464-e053-2a95a90a39b22024-12-09WarningsExact identifier
application number: M032
Skin Renewing CreamSALICYLIC ACIDAllure Labsfa54cf42-3ba7-b7b3-e053-6394a90aa7a02024-12-09WarningsExact identifier
application number: M032
Satinique Anti Dandruff Scalp and HairSALICYLIC ACIDAccess Business Group LLC03252c61-c51b-4e87-a06d-a61b8393704f2024-12-09WarningsExact identifier
application number: M032
Dry Skin Relief BarSALICYLIC ACIDCP Skin Health Group, Inc.eceb73b0-4c2f-4989-a3aa-a6553bc682522024-12-09WarningsExact identifier
application number: M032
Head and Shoulders Dual Pack Green ApplePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc8208bac-9d32-7694-e053-2a95a90a746c2024-11-27WarningsExact identifier
application number: M032
VanicreamPYRITHIONE ZINCPharmaceutical Specialties, Inc.d124a093-f739-0666-e053-2995a90a52ed2024-11-27WarningsExact identifier
application number: M032
LEAHUE MADHUCA TONICSALICYLIC ACIDBio-interchange Co.81454c8a-ddcf-7cef-e053-2991aa0a53c22024-11-27WarningsExact identifier
application number: M032
Hairitage Wash It Away Anti-Dandruff for Oily, Flaky ScalpSELENIUM SULFIDEMaesa, LLC.b09c3b0d-564e-45e4-b6ff-c1f0c12a95212024-11-13WarningsExact identifier
application number: M032
Hairitage Wash It Away Anti-Dandruff for Dry, Flaky ScalpSELENIUM SULFIDEMaesa, LLC.fa5d4ee3-fbeb-4379-bbd3-2b5b2cc454302024-11-12WarningsExact identifier
application number: M032
Marcs 2 in 1 Everyday Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.1daaa2c9-fbc7-4aa5-9772-e157109320662024-11-11WarningsExact identifier
application number: M032
Marcs Dry Scalp Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.ffab6ca6-7c8f-4080-836c-635a6ba3c0bb2024-11-11WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549328Head & Shoulders Clinical Strength 1 % Medicated ShampooPSNeedc5e57-8047-eab7-e053-2a95a90a2e2a4
204642selenium sulfide 1 % Medicated ShampooPSNeedc5e57-8047-eab7-e053-2a95a90a2e2a4
1549328selenium sulfide 10 MG/ML Medicated Shampoo [Head & Shoulders Clinical Strength]SBDeedc5e57-8047-eab7-e053-2a95a90a2e2a4
204642selenium sulfide 10 MG/ML Medicated ShampooSCDeedc5e57-8047-eab7-e053-2a95a90a2e2a4
1549328Head & Shoulders Clinical Solutions 10 MG/ML Medicated ShampooSYeedc5e57-8047-eab7-e053-2a95a90a2e2a4
1549328Head & Shoulders Clinical Strength 10 MG/ML Medicated ShampooSYeedc5e57-8047-eab7-e053-2a95a90a2e2a4
204642selenium sulfide 1 % Lotion ShampooSYeedc5e57-8047-eab7-e053-2a95a90a2e2a4
204642selenium sulfide 1 % Medicated ShampooSYeedc5e57-8047-eab7-e053-2a95a90a2e2a4
1549328selenium sulfide 10 MG/ML Medicated Shampoo [Head & Shoulders Clinical Solutions]SYeedc5e57-8047-eab7-e053-2a95a90a2e2a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-642-4069423064240400 mL in 1 BOTTLE, PLASTIC (69423-642-40) 400 ml2022-04-220000-00-00NoNoCurrent