FDA.reportPublic FDA data

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 17 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaZincPYRITHIONE ZINCWynnPharm Ince73010ae-291d-6adf-e053-2a95a90a8aea2025-11-14WarningsExact identifier
application number: M032
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

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