NDC 62565-903

ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM

Benzocaine, Butamben, Tetracaine Hydrochloride

ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM is a Dental; Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Hager Worldwide, Inc.. The primary component is Benzocaine; Butamben; Tetracaine Hydrochloride.

Product ID62565-903_b86fa8eb-3daa-4f1d-bbbe-6a87b21f13a9
NDC62565-903
Product TypeHuman Prescription Drug
Proprietary NameONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM
Generic NameBenzocaine, Butamben, Tetracaine Hydrochloride
Dosage FormGel
Route of AdministrationDENTAL; TOPICAL
Marketing Start Date2009-02-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameHAGER WORLDWIDE, INC.
Substance NameBENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE
Active Ingredient Strength28 mg/.2g; mg/.2g; mg/.2g
Pharm ClassesStandardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 62565-903-01

1 JAR in 1 BOX (62565-903-01) > 32 g in 1 JAR
Marketing Start Date2009-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62565-903-01 [62565090301]

ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-02-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE28 mg/.2g

OpenFDA Data

SPL SET ID:45c23713-43da-45b7-bec4-85127e34ca7c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308645
  • 885585
  • Pharmacological Class

    • Standardized Chemical Allergen [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Allergens [CS]
    • Esters [CS]
    • Local Anesthesia [PE]
    • Ester Local Anesthetic [EPC]

    NDC Crossover Matching brand name "ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM" or generic name "Benzocaine, Butamben, Tetracaine Hydrochloride"

    NDCBrand NameGeneric Name
    62565-902ONE TOUCH ADVANCED TOPICAL ANESTHETICBENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE
    62565-903ONE TOUCH ADVANCED TOPICAL ANESTHETICBENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE
    62565-904ONE TOUCH ADVANCED TOPICAL ANESTHETICBENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE
    62565-901ONE TOUCH ADVANCED TOPICAL ANESTHETIC GELBENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE

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