FDA.reportPublic FDA data

Topco Associates

Product NDC
76162-171
11-digit product format
761620171
Labeler code
76162
Product ID
76162-171_509ceebd-f4bc-f252-e063-6394a90abcd3
Type
HUMAN OTC DRUG
Nonproprietary name
Selenium Sulfide
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Topco Associates
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-04
Substance
SELENIUM SULFIDE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topco AssociatesSELENIUM SULFIDETopco Associatesecf87660-f552-1f6b-e053-2a95a90a24862023-05-04WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Ask a doctor before use if you have seborrheic dermatitis in areas other than the scalp. ■ avoid contact with eyes. If contact occurs, rinse thoroughly with water. ■ for use on 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. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Additional Listing Data#

Finished product
Yes
Brand name base
Topco Associates
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENIUM SULFIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ69D9E381Q
Rxcui204642

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-171-11Topco Associates325 mL in 1 BOTTLE, PLASTICSHAMPOO3255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-171TOPCO ASSOCIATES (SELENIUM SULFIDE) SHAMPOO [TOPCO ASSOCIATES]4Current NDC, 1 package rows20250213_ecf87660-f552-1f6b-e053-2a95a90a2486.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204642selenium sulfide 1 % Medicated ShampooPSNecf87660-f552-1f6b-e053-2a95a90a24865
204642selenium sulfide 10 MG/ML Medicated ShampooSCDecf87660-f552-1f6b-e053-2a95a90a24865
204642selenium sulfide 1 % Lotion ShampooSYecf87660-f552-1f6b-e053-2a95a90a24865
204642selenium sulfide 1 % Medicated ShampooSYecf87660-f552-1f6b-e053-2a95a90a24865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-171-1176162017111325 mL in 1 BOTTLE, PLASTIC (76162-171-11) 325 ml2023-05-04NoNoCurrent