FDA.reportPublic FDA data

Premier Value Lice Treatment Kit

Product NDC
68016-552
11-digit product format
680160552
Labeler code
68016
Product ID
68016-552_4253c3b5-7099-9ac6-e063-6394a90aac4a
Type
HUMAN OTC DRUG
Nonproprietary name
Piperonyl butoxide, Pyrethrum extract
Dosage form
KIT
Route
TOPICAL
Labeler
PHARMACY VALUE ALLIANCE LLC
Application
M031
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-09
Marketing end
2029-12-31
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
Premier Value Lice Treatment Kit

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
b60b24a6-fdca-244f-e053-2a95a90a3c4dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-12-06Premier Value Lice Treatment Kit
2023-12-06Premier Value Lice Treatment Kit
2023-01-30Premier Value Lice Treatment Kit
2023-01-30Premier Value Lice Treatment Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-552-01Premier Value Lice Treatment Kit1 in 1 CARTONKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-552PREMIER VALUE LICE TREATMENT KIT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) KIT [PHARMACY VALUE ALLIANCE LLC]3Current NDC, Legacy NDC, 1 package rows20250109_b60b24a6-fdca-244f-e053-2a95a90a3c4d.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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-552-01680160552011 KIT in 1 CARTON (68016-552-01) * 118 mL in 1 BOTTLE * 59 mL in 1 BOTTLE, SPRAY1 kit2020-12-092029-12-31NoNoCurrent