NDC 58809-650

Vanalice

Piperonyl Butoxide, Pyrethrum

Vanalice is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Piperonyl Butoxide; Pyrethrum Extract.

• Product ID: 58809-650_9d7784f9-eda0-456c-9ad9-1fe40e3cfa58
• NDC: 58809-650
• Product Type: Human Otc Drug
• Proprietary Name: Vanalice
• Generic Name: Piperonyl Butoxide, Pyrethrum
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-08-05
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part358G
• Labeler Name: GM Pharmaceuticals, INC
• Substance Name: PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
• Active Ingredient Strength: 35 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 58809-650-08

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

• Marketing Start Date: 2018-08-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58809-650-08 [58809065008]

Vanalice GEL

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part358G
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-08-05

Drug Details

Active Ingredients

Ingredient	Strength
PIPERONYL BUTOXIDE	35 mg/mL

OpenFDA Data

• SPL SET ID: c0205fa6-c8f4-4a28-9341-56a120843706
• Manufacturer:
  • GM Pharmaceuticals, INC
• UNII:
  • LWK91TU9AH
  • ZUM06L90GV
• RxNorm Concept Unique ID - RxCUI:
  • 2058508
  • 2058503

NDC Crossover Matching brand name "Vanalice" or generic name "Piperonyl Butoxide, Pyrethrum"

NDC	Brand Name	Generic Name
58809-650	Vanalice	Piperonyl butoxide, Pyrethrum
72902-001	HERKLIN Lice Treatment	PIPERONYL BUTOXIDE, PYRETHRUM
72902-002	HERKLIN Lice Treatment	PIPERONYL BUTOXIDE, PYRETHRUM
72902-003	HERKLIN Lice Treatment	PIPERONYL BUTOXIDE, PYRETHRUM
76413-350	Sunmark Lice Killing	Piperonyl butoxide, Pyrethrum