FDA.reportPublic FDA data

Lice Killing

Product NDC
68016-253
11-digit product format
680160253
Labeler code
68016
Product ID
68016-253_4253d519-704e-f5fa-e063-6294a90a51c5
Type
HUMAN OTC DRUG
Nonproprietary name
Piperonyl butoxide, Pyrethrum extract
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
PHARMACY VALUE ALLIANCE LLC
Application
M031
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-12
Marketing end
2029-12-31
Substance
PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
Active strength
4; .33 g/100mL; g/100mL
NDC exclude flag
No
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
Lice Killing

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LWK91TU9AHInternal UNII lookup
ZUM06L90GVInternal 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
b3dc154a-e341-5632-e053-2995a90affb2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-253-04Lice Killing1 in 1 CARTONSHAMPOO13
68016-253-04Lice Killing118 mL in 1 BOTTLESHAMPOO1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-253LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [PHARMACY VALUE ALLIANCE LLC]2Current NDC, Legacy NDC, 2 package rows20241222_b3dc154a-e341-5632-e053-2995a90affb2.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
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 ShampooPSNb60b24a6-fdca-244f-e053-2a95a90a3c4d4
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCDb60b24a6-fdca-244f-e053-2a95a90a3c4d4
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSYb60b24a6-fdca-244f-e053-2a95a90a3c4d4
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSNb3dc154a-e341-5632-e053-2995a90affb23
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCDb3dc154a-e341-5632-e053-2995a90affb23
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSYb3dc154a-e341-5632-e053-2995a90affb23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-253-04680160253041 BOTTLE in 1 CARTON (68016-253-04) / 118 mL in 1 BOTTLE1 bottle2020-10-122029-12-31NoNoCurrent