FDA.reportPublic FDA data

Selenium Sulfide

Product NDC
16477-422
11-digit product format
164770422
Labeler code
16477
Product ID
16477-422_42f7183b-5d80-674d-e063-6294a90a02f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selenium Sulfide
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Laser Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-04-11
Substance
SELENIUM SULFIDE
Active strength
22.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Selenium Sulfide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENIUM SULFIDE22.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z69D9E381QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
706548Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc6609b4-1757-3a13-e053-2995a90ac172Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16477-422-06Selenium Sulfide180 mL in 1 BOTTLESHAMPOO1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16477-422-06ML - Milliliter16477-4228b37082b-9e0f-45b9-9b40-f0bc4173f9d112022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16477-422SELENIUM SULFIDE SHAMPOO [LASER PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20250501_dc6609b4-1757-3a13-e053-2995a90ac172.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Selenium SulfideSELENIUM SULFIDELaser Pharmaceuticals, LLCdc6609b4-1757-3a13-e053-2995a90ac1722025-11-06Warnings, Adverse reactionsExact identifier
ndc (product): 16477-422

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
706548selenium sulfide 2.25 % Medicated ShampooPSNdc6609b4-1757-3a13-e053-2995a90ac1725
706548selenium sulfide 22.5 MG/ML Medicated ShampooSCDdc6609b4-1757-3a13-e053-2995a90ac1725
706548selenium sulfide 2.25 % Medicated ShampooSYdc6609b4-1757-3a13-e053-2995a90ac1725

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16477-422-0616477042206180 mL in 1 BOTTLE (16477-422-06) 180 ml2022-04-110000-00-00NoNoCurrent