Leader Therapeutic Dandruff

Product NDC
70000-0550
11-digit product format
700000550
Labeler code
70000
Product ID
70000-0550_d537537b-bd35-4c02-b7d8-357717887661
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Cardinal Health, 110 dba LEADER
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-30
Substance
SALICYLIC ACID
Active strength
30 mg/mL
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
Leader Therapeutic Dandruff
Brand name suffix
Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasis
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205023Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
509434a9-50c4-4337-8e5b-17bdc667d23bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0550-1Leader Therapeutic DandruffAnti-Dandruff, anti-seborrheic dematitis and anti-psoriasis133 mL in 1 BOTTLE, PLASTICSHAMPOO1335

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0550LEADER THERAPEUTIC DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DEMATITIS AND ANTI-PSORIASIS (SALICYLIC ACID) SHAMPOO [CARDINAL HEALTH]4Current NDC, Legacy NDC, 1 package rows20240315_509434a9-50c4-4337-8e5b-17bdc667d23b.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 · 613 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Marcs Everyday Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.69baf948-25fc-41d6-8980-23634634953b2024-11-11WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205023salicylic acid 3 % Medicated ShampooPSN509434a9-50c4-4337-8e5b-17bdc667d23b5
205023salicylic acid 30 MG/ML Medicated ShampooSCD509434a9-50c4-4337-8e5b-17bdc667d23b5
205023salicylic acid 3 % Medicated ShampooSY509434a9-50c4-4337-8e5b-17bdc667d23b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0550-170000055001133 mL in 1 BOTTLE, PLASTIC (70000-0550-1) 133 ml2022-08-300000-00-00NoNoCurrent