NDC 43498-319

Burkhart Topical Anesthetic

Benzocaine

Burkhart Topical Anesthetic is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Burkhart Dental Supply Inc. The primary component is Benzocaine.

Product ID43498-319_3d1f6d03-4225-40a5-ba02-d087f3234f81
NDC43498-319
Product TypeHuman Otc Drug
Proprietary NameBurkhart Topical Anesthetic
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2015-11-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameBurkhart Dental Supply Inc
Substance NameBENZOCAINE
Active Ingredient Strength200 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43498-319-30

30 g in 1 JAR (43498-319-30)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43498-319-30 [43498031930]

Burkhart Topical Anesthetic GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:aa09dcc0-e641-4c6d-8a84-ba890c0fce4c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238910

    • NDC Crossover Matching brand name "Burkhart Topical Anesthetic" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    43498-311Burkhart Topical AnestheticBurkhart Topical Anesthetic
    43498-313Burkhart Topical AnestheticBurkhart Topical Anesthetic
    43498-319Burkhart Topical AnestheticBurkhart Topical Anesthetic
    43498-312Burkhart Topical AnestheticBurkhart Topical Anesthetic
    43498-317Burkhart Topical AnestheticBurkhart Topical Anesthetic
    43498-318Burkhart Topical AnestheticBurkhart Topical Anesthetic
    43498-310Burkhart Topical AnestheticBurkhart Topical Anesthetic
    43498-314Burkhart Topical AnestheticBurkhart Topical Anesthetic
    43498-315Burkhart Topical AnestheticBurkhart Topical Anesthetic
    43498-316Burkhart Topical AnestheticBurkhart Topical Anesthetic
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE
    © 2026 FDA.report
    This site is not affiliated with or endorsed by the FDA.