NDC 43498-318

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 ID43498-318_d655d0ee-d5d6-555b-e053-2a95a90a1cfd
NDC43498-318
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
Pharm ClassesAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 43498-318-30

30 g in 1 JAR (43498-318-30)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43498-318-30 [43498031830]

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:b144aca9-91d1-4106-a39c-b928192ad41e
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
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