NDC 52083-714

Gumsol

Benzocaine, Zinc Chloride

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

Product ID52083-714_9f4c663e-aa3c-4190-83c7-61ec6f0a4eb7
NDC52083-714
Product TypeHuman Otc Drug
Proprietary NameGumsol
Generic NameBenzocaine, Zinc Chloride
Dosage FormSpray
Route of AdministrationORAL
Marketing Start Date2014-02-28
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameKramer Novis
Substance NameBENZOCAINE; ZINC CHLORIDE
Active Ingredient Strength2 g/30mL; g/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52083-714-01

30 mL in 1 BOTTLE (52083-714-01)
Marketing Start Date2014-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-714-01 [52083071401]

Gumsol SPRAY
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-02-28

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE1.5 g/30mL

OpenFDA Data

SPL SET ID:3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485558
  • NDC Crossover Matching brand name "Gumsol" or generic name "Benzocaine, Zinc Chloride"

    NDCBrand NameGeneric Name
    52083-713GumsolBenzocaine, Zinc Chloride
    52083-714GumsolBenzocaine, Zinc Chloride

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