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

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
Topco Associates
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENIUM SULFIDE10 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
204642Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ecf87660-f552-1f6b-e053-2a95a90a2486Available on FDA.report

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

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 3 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antifungal Psoriasis Shampoo.SALICYLIC ACID 2%Trovina Co. Ltd5512ac82-e3c5-37e6-e063-6294a90a92d62026-07-01WarningsExact identifier
application number: M032
Anti-fungalANTI-FUNGAL SHAMPOOShenzhen Chaoxiji Technology Co.,Ltd.555cb4fa-6f59-fa69-e063-6394a90a1db62026-06-28WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC55246263-7345-ba65-e063-6294a90ab1632026-06-26WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc552926da-0dfb-4248-e063-6294a90ab4a82026-06-26WarningsExact identifier
application number: M032
Dermoia Seborrheic Dermatitis Selenium SulfideSELENIUM SULFIDETREASUREWISE LLC04b8532e-44a7-4eaf-a46d-87611ec93c242026-06-23WarningsExact identifier
application number: M032
Dermgentle Seborrheic Scalp SerumPYRITHIONE ZINCDermgentle LLC54a0901a-404f-ea0e-e063-6294a90a6dc72026-06-19WarningsExact identifier
application number: M032
Silvagle Selenium Sulfide Anti DandruffShampooSELENIUM SULFIDEGUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD54885ae3-7e2f-7bd2-e063-6394a90a97fe2026-06-18WarningsExact identifier
application number: M032
Pharmlitalia Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd845a82f6-7d0e-416d-b5b0-bf788dca2f542026-06-18WarningsExact identifier
application number: M032
anti dandruff SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD5459e831-41e7-f1c7-e063-6394a90ae0982026-06-16WarningsExact identifier
application number: M032
ANTI DANDRUFF SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD545780f9-a202-95e9-e063-6394a90a982f2026-06-15WarningsExact identifier
application number: M032
Swiftalyn Antifungal Scalp Shampoo.SALICYLIC ACID 2%GENUINE INNOVATION LTD53f84e9f-ecc1-dfc2-e063-6394a90af2432026-06-11WarningsExact identifier
application number: M032
Anti-DandruffZINC PYRITHIONEMEERAY COSMETICS CO., LTD.f5b2d9f2-ff29-2da1-e053-2995a90a68f32026-06-08WarningsExact identifier
application number: M032
Psoriasin Deep MoisturizingCOAL TARKobayashi Healthcare International, Inc.8bb4a84f-dd80-cbbc-e053-2a95a90a04752026-06-08WarningsExact identifier
application number: M032
Head and Shoulders Hutchs Cooling RushPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5383143a-f930-46f8-e063-6294a90a3a752026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Double Coverage 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53835f68-44d8-b1af-e063-6294a90acae92026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Polamalu s Hall of Fame HairPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53839833-d1c2-fa3b-e063-6394a90a6bd92026-06-05WarningsExact identifier
application number: M032
RENUEVO ANTI-DAMDRUFFZINC PYRITHIONELEON UP GLOBAL HOLDING CORP5387b840-ad0a-4c20-e063-6294a90a59e32026-06-05WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Medicated Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Health307e4b16-10ab-44f4-86b9-709d10566d4c2026-06-04WarningsExact identifier
application number: M032
Minoxidil Hair Growth SerumMINOXIDILShenzhen Deshijian Medical Equipment Co., Ltd535cdf78-90bc-86b4-e063-6294a90a2c202026-06-04WarningsExact identifier
application number: M032
Dermaharmony Unscented BarSALICYLIC ACIDD3 Development, Inc.52f5885f-2a40-c3f5-e063-6294a90a434e2026-05-29WarningsExact identifier
application number: M032

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