vanalice

Generic: piperonyl butoxide, pyrethrum

Labeler: gm pharmaceuticals, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name vanalice
Generic Name piperonyl butoxide, pyrethrum
Labeler gm pharmaceuticals, inc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

piperonyl butoxide 35 mg/mL, pyrethrum extract 3 mg/mL

Manufacturer
GM Pharmaceuticals, INC

Identifiers & Regulatory

Product NDC 58809-650
Product ID 58809-650_4510adbf-3258-b683-e063-6394a90a53d2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M031
Listing Expiration 2026-12-31
Marketing Start 2018-08-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58809650
Hyphenated Format 58809-650

Supplemental Identifiers

RxCUI
2058503 2058508
UNII
LWK91TU9AH ZUM06L90GV

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vanalice (source: ndc)
Generic Name piperonyl butoxide, pyrethrum (source: ndc)
Application Number M031 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 35 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (58809-650-08)
source: ndc

Packages (1)

58809-650-08 237 mL in 1 BOTTLE (58809-650-08)

Ingredients (2)

piperonyl butoxide (35 mg/mL) pyrethrum extract (3 mg/mL)

Linked Drug Pages (1)

Vanalice ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4510adbf-3258-b683-e063-6394a90a53d2", "openfda": {"unii": ["LWK91TU9AH", "ZUM06L90GV"], "rxcui": ["2058503", "2058508"], "spl_set_id": ["c0205fa6-c8f4-4a28-9341-56a120843706"], "manufacturer_name": ["GM Pharmaceuticals, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (58809-650-08)", "package_ndc": "58809-650-08", "marketing_start_date": "20180805"}], "brand_name": "Vanalice", "product_id": "58809-650_4510adbf-3258-b683-e063-6394a90a53d2", "dosage_form": "GEL", "product_ndc": "58809-650", "generic_name": "Piperonyl butoxide, Pyrethrum", "labeler_name": "GM Pharmaceuticals, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Vanalice", "active_ingredients": [{"name": "PIPERONYL BUTOXIDE", "strength": "35 mg/mL"}, {"name": "PYRETHRUM EXTRACT", "strength": "3 mg/mL"}], "application_number": "M031", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180805", "listing_expiration_date": "20261231"}