FDA.reportPublic FDA data

Weeks and Leo Complete Lice Treatment

Product NDC
11383-255
Requested package NDC
11383-255-01
11-digit product format
113830255
Labeler code
11383
Product ID
11383-255_0c1adbad-90bc-b402-e063-6294a90a5712
Type
HUMAN OTC DRUG
Nonproprietary name
Piperonyl butoxide, Pyrethrum extract
Dosage form
KIT
Route
TOPICAL
Labeler
Weeks & Leo Co., Inc.
Application
M031
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-10-28
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
Weeks and Leo Complete Lice Treatment
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
499bdb9f-c235-3293-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11383-255-01Weeks and Leo Complete Lice Treatment1 in 1 CARTONKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11383-255WEEKS AND LEO COMPLETE LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) KIT [WEEKS & LEO CO., INC.]8Current NDC, Legacy NDC, 1 package rows20231210_499bdb9f-c235-3293-e054-00144ff8d46c.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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ndc (package): 11383-255-01
ndc (product): 11383-255
ndc11 (package): 11383025501
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
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
Foster and Thrive Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTStrategic Sourcing Services, LLC0b53591f-6181-b75a-e063-6294a90a49e32023-11-29WarningsExact identifier
application number: M031

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSN499bdb9f-c235-3293-e054-00144ff8d46c8
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCD499bdb9f-c235-3293-e054-00144ff8d46c8
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSY499bdb9f-c235-3293-e054-00144ff8d46c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11383-255-01113830255011 KIT in 1 CARTON (11383-255-01) * 118 mL in 1 BOTTLE1 kit2014-01-030000-00-00NoNoCurrent