Home NDC 70000-0531 Leader Medicated Dandruff
Product NDC 70000-0531
11-digit product format 700000531
Labeler code 70000
Product ID 70000-0531_8fce31c4-f08b-4c6f-96ea-59f59add8cfe
Type HUMAN OTC DRUG
Nonproprietary name Selenium Sulfide
Dosage form SHAMPOO
Route TOPICAL
Labeler Cardinal Health, 110 dba LEADER
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-05
Substance SELENIUM SULFIDE
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only As a doctor before use if condition covers a large area of the body. When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. for color-treated or permed hair, rinse thoroughly. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Additional Listing Data#
Finished product Yes
Brand name base Leader Medicated Dandruff
Brand name suffix Anti-Seborrheic Dermatitis, Anti-Dandruff
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SELENIUM SULFIDE 10 mg/mL
Harmonized Identifiers# Field, Values table Field Values Unii Z69D9E381Q Rxcui 204642
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0531-1 Leader Medicated DandruffAnti-Seborrheic Dermatitis, Anti-Dandruff 207 mL in 1 BOTTLE, PLASTIC SHAMPOO 207 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0531 LEADER MEDICATED DANDRUFF ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF (SELENIUM SULFIDE) SHAMPOO [CARDINAL HEALTH, 110 DBA LEADER] 4 Current NDC, Legacy NDC, 1 package rows 20240315_3f64a2ef-a415-49b0-bf14-eb4da66d511f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0531-1 70000053101 207 mL in 1 BOTTLE, PLASTIC (70000-0531-1) 207 ml 2019-11-05 0000-00-00 No No Current