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

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 1 of 3 · 43 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 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
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
ndc (product): 68016-253
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
ZAP Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTDLC laboratories Inc.82d24cd9-6615-7901-e053-2991aa0ad1682024-12-23WarningsExact 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