FDA.reportPublic FDA data

Topcare Complete Lice Treatment Kit

Product NDC
76162-255
Requested package NDC
76162-255-01
11-digit product format
761620255
Labeler code
76162
Product ID
76162-255_4359defa-46d6-e860-e063-6294a90a0179
Type
HUMAN OTC DRUG
Nonproprietary name
Piperonyl butoxide, Pyrethrum extract
Dosage form
KIT
Route
TOPICAL
Labeler
Topco Associates, LLC
Application
M031
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Complete Lice Treatment Kit
Listing expiration
2026-12-31

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
0bf3980f-d10d-afc9-e063-6294a90acbf5Available 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
76162-255-01Topcare Complete Lice Treatment Kit1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-255TOPCARE COMPLETE LICE TREATMENT KIT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) KIT [TOPCO ASSOCIATES, LLC]2Current NDC, 2 package rows20250109_0bf3980f-d10d-afc9-e063-6294a90acbf5.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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bldaxn Ivermectin Lotion0.5%BLDAXN IVERMECTIN LOTION 0.5%GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5679e6f5-1ee8-ee46-e063-6394a90a8d642026-07-13WarningsExact identifier
application number: M031
RID Lice Treatment Complete KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTOystershell Consumer Health Inc6fd3531a-3d51-4251-89db-808c9f75e4ea2026-06-25WarningsExact identifier
application number: M031
Kakshal PermethrinPERMETHRINKakshal4ddc2aef-daef-13a9-e063-6394a90af3e32026-05-08WarningsExact identifier
application number: M031
lice treatment dedicatedIVERMETShenzhen Zhenshangzekai Technology Co., Ltd.459aafa5-08d4-3667-e063-6294a90a3b942025-12-12WarningsExact identifier
application number: M031
lice treatment dedicatedIVERMECTINShenzhen Zhenshangzekai Technology Co., Ltd.459879fb-efd1-9fc1-e063-6394a90a98b02025-12-10WarningsExact identifier
application number: M031
ivometn ivermectin lice treatmentIVERMECTINShenzhen Zhenshangzekai Technology Co., Ltd.459b4316-89df-0bb1-e063-6294a90a518d2025-12-10WarningsExact identifier
application number: M031
VanalicePIPERONYL BUTOXIDE, PYRETHRUMGM Pharmaceuticals, INCc0205fa6-c8f4-4a28-9341-56a1208437062025-12-03WarningsExact identifier
application number: M031
Quality Choice Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTChain Drug Marketing Association1f4392ba-f405-7ee1-e063-6394a90ae6312025-11-12WarningsExact identifier
application number: M031
Topcare Complete Lice Treatment KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTTopco Associates, LLC0bf3980f-d10d-afc9-e063-6294a90acbf52025-11-11WarningsExact identifier
application number: M031
ndc (package): 76162-255-01
ndc (product): 76162-255
ndc11 (package): 76162025501
Leader Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTLEADER/ Cardinal Health 110, Inc.fea8ca80-2392-160f-e053-6294a90ae6fe2025-10-29WarningsExact identifier
application number: M031
ABC Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWeeks & Leo Co., Inc.1046aa13-4dda-d5f8-e063-6394a90a714e2025-10-29WarningsExact identifier
application number: M031
GoodSense Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPerrigo Direct, Inc.0bf1cdd7-7bdb-1aa0-e063-6294a90a517f2025-10-29WarningsExact identifier
application number: M031
Walgreens Lice EliminationPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWalgreens8876272e-6bfd-6844-e053-2995a90a834f2025-10-29WarningsExact identifier
application number: M031
Premier Value Lice Treatment KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPHARMACY VALUE ALLIANCE LLCb60b24a6-fdca-244f-e053-2a95a90a3c4d2025-10-29WarningsExact identifier
application number: M031
Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPHARMACY VALUE ALLIANCE LLCb3dc154a-e341-5632-e053-2995a90affb22025-10-29WarningsExact identifier
application number: M031
Mata Piojos LicePIPERONYL BUTOXIDE, PYRETHRUM EXTRACTGRANDALL DISTRIBUTING, LLC1de4e361-4e7b-4f7e-b6c8-30fa21e75bea2025-10-27WarningsExact identifier
application number: M031
LIENDREXPYRETHRUM EXTRACT, PIPERONYL BUTOXIDEMenper Distributors Inc.65f86a0d-0cf7-42f6-84de-4dc9e7791aba2025-07-22WarningsExact identifier
application number: M031
Lice No More Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWeeks & Leo Co., Inc372819f1-0817-2cd5-e063-6294a90ac5bf2025-06-09WarningsExact identifier
application number: M031
Rite Aid Complete Lice Elimination KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTRite Aid0bf40aa5-b931-663e-e063-6394a90a803f2025-01-07WarningsExact identifier
application number: M031
Quita Piojos Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTDLC Laboratories82ce4cf7-ea46-c838-e053-2991aa0a9c382024-12-23WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-255-01761620255011 KIT in 1 CARTON (76162-255-01) * 118 mL in 1 BOTTLE (76162-253-04) * 59 mL in 1 BOTTLE, SPRAY1 kit2023-10-01NoNoCurrent