FDA.reportPublic FDA data

Topcare Lice Killing

Product NDC
76162-253
11-digit product format
761620253
Labeler code
76162
Product ID
76162-253_0be04ad2-e1b6-d3fb-e063-6394a90ab8e5
Type
HUMAN OTC DRUG
Nonproprietary name
Piperonyl Butoxide, Pyrethrum Extract
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Topco Associates, LLC
Application
M031
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-01
Substance
PYRETHRUM EXTRACT; PIPERONYL BUTOXIDE
Active strength
.33; 4 g/100mL; g/100mL
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
Topcare Lice Killing
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRETHRUM EXTRACT.33 g/100mL
PIPERONYL BUTOXIDE4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZUM06L90GVInternal UNII lookup
LWK91TU9AHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283219Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0be04816-e173-8046-e063-6294a90acdb6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-253-04Topcare Complete Lice Treatment Kit118 mL in 1 BOTTLESHAMPOO118 mL4 g in 100mL3
76162-253-08Topcare Lice Killing236 mL in 1 BOTTLESHAMPOO2361
76162-253-08Topcare Lice Killing1 in 1 CARTONSHAMPOO11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-253TOPCARE COMPLETE LICE TREATMENT KIT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) KIT [TOPCO ASSOCIATES, LLC]2Current NDC20250109_0bf3980f-d10d-afc9-e063-6294a90acbf5.zip
76162-253TOPCARE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [TOPCO ASSOCIATES, LLC]1Current NDC, 2 package rows20231207_0be04816-e173-8046-e063-6294a90acdb6.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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTMeijer, Inc.0191bc62-aa7c-874a-e063-6294a90a95b92024-12-19WarningsExact identifier
application number: M031
Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWeeks & Leo Co., Inc.c3647aca-7fb9-e2f4-e053-2995a90a7acb2024-12-13WarningsExact identifier
application number: M031
GoodSense Complete Lice Treatment KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPerrigo Direct, LLC0c03564e-d9db-d148-e063-6394a90a7d7f2024-12-13WarningsExact identifier
application number: M031
Kroger Complete Lice Treatment KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTThe Kroger Co0c0308c9-72d2-d29b-e063-6294a90a6ef52024-12-13WarningsExact identifier
application number: M031
Quality Choice Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTQuality Choice291b45a4-0527-79e4-e063-6294a90aa47a2024-12-12WarningsExact identifier
application number: M031
El Piojito Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPharmadel487f72e0-e2c6-32ea-e054-00144ff8d46c2024-12-12WarningsExact identifier
application number: M031
RID Lice KillingPIPERONYL BUTOXIDE AND PYRETHRUM EXTRACTOystershell Consumer Health Inc55102839-05f2-41ac-a20e-1b2d7a3f4be62023-12-20WarningsExact identifier
application number: M031
Discount Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTDiscount drug mart88ede7e6-82d6-db8a-e053-2a95a90a00be2023-12-12WarningsExact identifier
application number: M031
Best Choice Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTAssociated Wholesale Grocers, Inc.89019cc4-9ff4-3fd5-e053-2a95a90a31252023-12-09WarningsExact identifier
application number: M031
Weeks and Leo Complete Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWeeks & Leo Co., Inc.499bdb9f-c235-3293-e054-00144ff8d46c2023-12-09WarningsExact identifier
application number: M031
CVS 3 Step Lice SolutionPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTCVS49cd21fc-282e-103b-e054-00144ff88e882023-12-08WarningsExact identifier
application number: M031
CVS 3 Step Lice SolutionPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTCVS82e11c44-3802-d680-e053-2991aa0a991c2023-12-08WarningsExact identifier
application number: M031
Kroger Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTThe Kroger Co0bf17178-c33f-d6fb-e063-6294a90a884a2023-12-07WarningsExact identifier
application number: M031
Discount Drug Mart Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTDiscount Drug Mart480b334d-c212-0045-e054-00144ff88e882023-12-07WarningsExact identifier
application number: M031
Walgreens Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWalgreens CO82bbdd69-1ad1-ec84-e053-2991aa0a15fc2023-12-07WarningsExact identifier
application number: M031
Family Wellness Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTFamily Dollar0be00786-d700-4082-e063-6294a90a4f872023-12-06WarningsExact identifier
application number: M031
Topcare Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTTopco Associates, LLC0be04816-e173-8046-e063-6294a90acdb62023-12-06WarningsExact identifier
application number: M031
ndc (product): 76162-253
Major Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTMajor Pharmaceuticals0bc94e0e-6772-425e-e063-6394a90a6bf12023-12-05WarningsExact identifier
application number: M031
GNP Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTAmerisourceBergen Drug Corporation0bc99cab-0996-55ee-e063-6294a90a3dc52023-12-05WarningsExact identifier
application number: M031
Rite Aid Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTRite Aid Corp0bca8a15-ed57-ab4b-e063-6394a90ae3db2023-12-05WarningsExact identifier
application number: M031

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSN0bf3980f-d10d-afc9-e063-6294a90acbf53
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCD0bf3980f-d10d-afc9-e063-6294a90acbf53
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSY0bf3980f-d10d-afc9-e063-6294a90acbf53
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSN0be04816-e173-8046-e063-6294a90acdb61
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCD0be04816-e173-8046-e063-6294a90acdb61
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSY0be04816-e173-8046-e063-6294a90acdb61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-253-0476162025304118 mL in 1 BOTTLE118 mlHistorical
76162-253-08761620253081 BOTTLE in 1 CARTON (76162-253-08) / 236 mL in 1 BOTTLE1 bottle2023-11-01NoNoCurrent