NDC 52083-713

Gumsol

Benzocaine, Zinc Chloride

Gumsol is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Benzocaine; Zinc Chloride.

• Product ID: 52083-713_371d4ba3-420a-412c-ad8a-d88aa68c0d5b
• NDC: 52083-713
• Product Type: Human Otc Drug
• Proprietary Name: Gumsol
• Generic Name: Benzocaine, Zinc Chloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2014-02-28
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Kramer Novis
• Substance Name: BENZOCAINE; ZINC CHLORIDE
• Active Ingredient Strength: 2 g/30mL; g/30mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52083-713-01

30 mL in 1 BOTTLE (52083-713-01)

• Marketing Start Date: 2014-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52083-713-01 [52083071301]

Gumsol SOLUTION

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-02-28

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	1.5 g/30mL

OpenFDA Data

• SPL SET ID: 3ef75f3c-cc00-4b39-9249-161da76bb9a7
• Manufacturer:
  • Kramer Novis
• UNII:
  • U3RSY48JW5
  • 86Q357L16B
• RxNorm Concept Unique ID - RxCUI:
  • 485560

NDC Crossover Matching brand name "Gumsol" or generic name "Benzocaine, Zinc Chloride"

NDC	Brand Name	Generic Name
52083-713	Gumsol	Benzocaine, Zinc Chloride
52083-714	Gumsol	Benzocaine, Zinc Chloride