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Drug Information

Product NDC: 52083-714

Proprietary Name: Gumsol

Non Proprietary Name: Benzocaine, Zinc Chloride

Active Ingredient(s):
  • 1.5 g/30mL BENZOCAINE;
  • .03 g/30mL ZINC CHLORIDE

Administration Route(s): ORAL

Dosage Form(s): SPRAY

Pharmacy Class(es):
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Copper Absorption Inhibitor [EPC];
  • Decreased Copper Ion Absorption [PE];
  • Increased Histamine Release [PE];
  • Standardized Chemical Allergen [EPC]

Labeler Information

Labeler Name: Kramer Novis
Product Type: HUMAN OTC DRUG
FDA Application Number: part356
Start Marketing Date:2/28/2014

Package Information

No. Package Code Package Description Billing Unit
152083-714-0130 mL in 1 BOTTLE (52083-714-01)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC52083-714The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEGumsolThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBenzocaine, Zinc ChlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAYThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/28/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at under Structured Product Labeling Resources.
APPLICATION NUMBERpart356This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEKramer NovisName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBENZOCAINE; ZINC CHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] 

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This page was last updated on: 2/1/2023