NDC 71831-001

Pranicura

Glycerin, Calamine, Aluminum Hydroxide, Menthol

Pranicura is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Pranicura, Llc. The primary component is Glycerin; Zinc Oxide; Aluminum Hydroxide; Menthol.

• Product ID: 71831-001_e78fc2c0-00a6-4bee-924a-cc4d9b7c2858
• NDC: 71831-001
• Product Type: Human Otc Drug
• Proprietary Name: Pranicura
• Generic Name: Glycerin, Calamine, Aluminum Hydroxide, Menthol
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-11-08
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part346
• Labeler Name: Pranicura, LLC
• Substance Name: GLYCERIN; ZINC OXIDE; ALUMINUM HYDROXIDE; MENTHOL
• Active Ingredient Strength: 18 g/70g; g/70g; g/70g; g/70g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71831-001-01

70 g in 1 JAR (71831-001-01)

• Marketing Start Date: 2017-11-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71831-001-01 [71831000101]

Pranicura OINTMENT

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-11-09
• Marketing End Date: 2019-02-15

Drug Details

Active Ingredients

Ingredient	Strength
GLYCERIN	17.5 g/70g

OpenFDA Data

• SPL SET ID: 5d80e97e-ff00-c396-e053-2a91aa0a923e
• Manufacturer:
  • Pranicura, LLC
• UNII:
  • SOI2LOH54Z
  • L7T10EIP3A
  • 5QB0T2IUN0
  • PDC6A3C0OX

NDC Crossover Matching brand name "Pranicura" or generic name "Glycerin, Calamine, Aluminum Hydroxide, Menthol"

NDC	Brand Name	Generic Name
71831-001	Pranicura	Glycerin, Calamine, Aluminum Hydroxide, Menthol
71831-002	Pranicura	GLYCERIN, KAOLIN, CALAMINE, MENTHOL