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

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 Identifiers#

Field, Values table
FieldValues
UniiLWK91TU9AH, ZUM06L90GV
Rxcui2058503, 2058508

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

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