NDC 68400-461

Comfortcaine Topical Anesthetic

Benzocaine

Comfortcaine Topical Anesthetic is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. The primary component is Benzocaine.

Product ID68400-461_d65b2850-fb65-e92d-e053-2a95a90a42c2
NDC68400-461
Product TypeHuman Otc Drug
Proprietary NameComfortcaine Topical Anesthetic
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2018-11-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products 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 68400-461-30

30 g in 1 JAR (68400-461-30)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68400-461-30 [68400046130]

Comfortcaine Topical Anesthetic GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:fda3d254-e103-4be9-9086-51ad022b2b3f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238910

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

    NDCBrand NameGeneric Name
    68400-461Comfortcaine Topical AnestheticComfortcaine Topical Anesthetic
    68400-999ComfortCaine Topical AnestheticComfortCaine Topical Anesthetic
    68400-997ComfortCaine Topical AnestheticComfortCaine Topical Anesthetic
    68400-998ComfortCaine Topical AnestheticComfortCaine Topical Anesthetic
    68400-459Comfortcaine Topical AnestheticComfortcaine Topical Anesthetic
    68400-457Comfortcaine Topical AnestheticComfortcaine Topical Anesthetic
    68400-458Comfortcaine Topical AnestheticComfortcaine Topical Anesthetic
    68400-460Comfortcaine Topical AnestheticComfortcaine Topical Anesthetic
    68400-996ComfortCaine Topical AnestheticComfortCaine Topical Anesthetic
    68400-456Comfortcaine Topical AnestheticComfortcaine 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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