0699-7031 NDC - TOPEX (BENZOCAINE)

Drug Information

Product NDC: 0699-7031

Proprietary Name: Topex

Non Proprietary Name: Benzocaine

Active Ingredient(s):
  • 220 mg/g BENZOCAINE


Administration Route(s): DENTAL

Dosage Form(s): GEL, DENTIFRICE

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

Labeler Information

Labeler Name: Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:2/19/1963

Package Information

No. Package Code Package Description Billing Unit
10699-7031-3434 g in 1 JAR (0699-7031-34)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0699-7031The 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 PRESCRIPTION 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 NAMETopexThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXBubble GumA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEBenzocaineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGEL, DENTIFRICEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEDENTALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/19/1963This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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 www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEDentsply LLC. Professional Division Trading as "Sultan Healthcare"Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBENZOCAINEAn 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.
ACTIVE NUMERATOR STRENGTH220 
ACTIVE INGRED UNITmg/g 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] 

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