Home NDC 51316-387 CVS Health MAXIMUM STRENGTH Dandruff
Product NDC 51316-387
11-digit product format 513160387
Labeler code 51316
Product ID 51316-387_ea834f19-5ec1-4628-ae03-cd8e8a2b38a6
Type HUMAN OTC DRUG
Nonproprietary name Selenium sulfide
Dosage form SHAMPOO
Route TOPICAL
Labeler CVS Health
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-28
Substance SELENIUM SULFIDE
Active strength 10 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 CVS Health MAXIMUM STRENGTH 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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z69D9E381Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204642 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51316-387-01 CVS Health MAXIMUM STRENGTH DandruffAnti-Seborrheic Dermatitis, anti-dandruff 325 mL in 1 BOTTLE SHAMPOO 325 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-387 CVS HEALTH MAXIMUM STRENGTH DANDRUFF ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF (SELENIUM SULFIDE) SHAMPOO [CVS HEALTH] 1 Current NDC, 1 package rows 20240926_cff51af6-84de-4ba5-ac99-9bc42a65c9a5.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 15 of 31 · 615 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-387-01 51316038701 325 mL in 1 BOTTLE (51316-387-01) 325 ml 2024-08-28 No No Current