FDA.reportPublic FDA data

Vanalice

Product NDC
58809-650
11-digit product format
588090650
Labeler code
58809
Product ID
58809-650_4510adbf-3258-b683-e063-6394a90a53d2
Type
HUMAN OTC DRUG
Nonproprietary name
Piperonyl butoxide, Pyrethrum
Dosage form
GEL
Route
TOPICAL
Labeler
GM Pharmaceuticals, INC
Application
M031
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-05
Substance
PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
Active strength
35; 3 mg/mL; mg/mL
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
Vanalice
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERONYL BUTOXIDE35 mg/mL
PYRETHRUM EXTRACT3 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2058503Internal RxNorm lookup
2058508Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0205fa6-c8f4-4a28-9341-56a120843706Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-650-08Vanalice237 mL in 1 BOTTLEGEL23710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-650-08ML - Milliliter58809-65049239f0e-8690-43d8-9cb2-28d861f354f712018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-650VANALICE (PIPERONYL BUTOXIDE, PYRETHRUM) GEL [GM PHARMACEUTICALS, INC]9Current NDC, Legacy NDC, 1 package rows20231208_c0205fa6-c8f4-4a28-9341-56a120843706.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
2058503piperonyl butoxide 3.5 % / pyrethrins 0.3 % Topical GelPSNc0205fa6-c8f4-4a28-9341-56a12084370610
2058508VanaLice 3.5 % / 0.03 % Topical GelPSNc0205fa6-c8f4-4a28-9341-56a12084370610
2058508piperonyl butoxide 0.035 MG/MG / pyrethrins 0.003 MG/MG Topical Gel [Vanalice]SBDc0205fa6-c8f4-4a28-9341-56a12084370610
2058503piperonyl butoxide 0.035 MG/MG / pyrethrins 0.003 MG/MG Topical GelSCDc0205fa6-c8f4-4a28-9341-56a12084370610
2058503piperonyl butoxide 3.5 % / pyrethrins 0.3 % Topical GelSYc0205fa6-c8f4-4a28-9341-56a12084370610
2058508Vanalice (piperonyl butoxide 3.5 % / pyrethrins 0.03 % ) Topical GelSYc0205fa6-c8f4-4a28-9341-56a12084370610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58809-650-0858809065008237 mL in 1 BOTTLE (58809-650-08) 237 ml2018-08-050000-00-00NoNoCurrent