NDC 68400-994

Comfortcaine

Benzocaine

Comfortcaine 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 Deepack Products Inc.. The primary component is Benzocaine.

Product ID68400-994_6cf42857-63fc-a60b-e053-2991aa0aa2f1
NDC68400-994
Product TypeHuman Otc Drug
Proprietary NameComfortcaine
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date1997-01-01
Marketing End Date2020-09-30
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameMycone Dental Supply Co., Inc DBA Keystone Industries and Deepack Products Inc.
Substance NameBENZOCAINE
Active Ingredient Strength200 mg/g
NDC Exclude FlagN

Packaging

NDC 68400-994-01

30 g in 1 BOTTLE, PLASTIC (68400-994-01)
Marketing Start Date1997-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68400-994-01 [68400099401]

Comfortcaine GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date1997-01-01
Marketing End Date2020-09-30

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:603ef657-b34e-633f-e053-2a91aa0a847f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238910
  • NDC Crossover Matching brand name "Comfortcaine" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    68400-994ComfortcaineComfortcaine
    65008-005ComfortcaineComfortcaine
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE

    Trademark Results [Comfortcaine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COMFORTCAINE
    COMFORTCAINE
    88953740 not registered Live/Pending
    QS KEY WEST ALOE, LLC
    2020-06-08
    COMFORTCAINE
    COMFORTCAINE
    75146914 2194103 Live/Registered
    MYCONE DENTAL SUPPLY CO., INC.
    1996-08-08
    COMFORTCAINE
    COMFORTCAINE
    73489139 1350221 Live/Registered
    KEY WEST FRAGRANCE & COSMETIC FACTORY, INC.
    1984-07-09

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.