NDC 10216-3091

Topex Pina Colada

Benzocaine

Topex Pina Colada is a Dental Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Dentsply Caulk. The primary component is Benzocaine.

Product ID10216-3091_983a1364-6118-4d7e-9b80-5011306c0b7d
NDC10216-3091
Product TypeHuman Prescription Drug
Proprietary NameTopex Pina Colada
Generic NameBenzocaine
Dosage FormGel, Dentifrice
Route of AdministrationDENTAL
Marketing Start Date1963-02-19
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameDENTSPLY Caulk
Substance NameBENZOCAINE
Active Ingredient Strength220 mg/g
Pharm ClassesStandardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10216-3091-1

100 g in 1 JAR (10216-3091-1)
Marketing Start Date1963-02-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10216-3091-1 [10216309101]

Topex Pina Colada GEL, DENTIFRICE
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1963-02-19
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE220 mg/g

OpenFDA Data

SPL SET ID:db4f2105-9e47-45b6-b550-6397708eb335
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238910

    • Pharmacological Class

    • Standardized Chemical Allergen [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Allergens [CS]

    NDC Crossover Matching brand name "Topex Pina Colada" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    0699-7091Topex Pina ColadaTopex Pina Colada
    0699-7001Topex Pina ColadaTopex Pina Colada
    0699-3112Topex Pina ColadaTopex Pina Colada
    10216-3091Topex Pina ColadaTopex Pina Colada
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE

    Trademark Results [Topex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TOPEX
    TOPEX
    87126547 5348643 Live/Registered
    Sodimac S.A.
    2016-08-03
    TOPEX
    TOPEX
    85707237 4422900 Live/Registered
    TOPEX AUTOMOTIVE CORPORATION
    2012-08-18
    TOPEX
    TOPEX
    78975660 2992614 Live/Registered
    EE&P Corporation
    2003-09-23
    TOPEX
    TOPEX
    78304122 not registered Dead/Abandoned
    EE&P Corporation
    2003-09-23
    TOPEX
    TOPEX
    75392125 2562717 Live/Registered
    TOPEX GMBH
    1997-11-18
    TOPEX
    TOPEX
    74512982 1900299 Live/Registered
    DENTSPLY SIRONA INC.
    1994-04-15
    TOPEX
    TOPEX
    73592400 1466199 Dead/Cancelled
    TECHNOLOGY MODELING ASSOCIATES, INC.
    1986-04-09
    TOPEX
    TOPEX
    73311247 1230532 Dead/Cancelled
    Topex International
    1981-05-20
    TOPEX
    TOPEX
    73156494 1100101 Dead/Cancelled
    1978-01-25
    TOPEX
    TOPEX
    73091490 1059782 Dead/Cancelled
    RICHARDSON-MERRELL INC.
    1976-06-24
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