NDC 64778-0393

Denti-Care Denti-Freeze Topical Anesthetic Bubblegum

Benzocaine, Tetracaine Hydrochloride

Denti-Care Denti-Freeze Topical Anesthetic Bubblegum is a Dental Gel in the Human Prescription Drug category. It is labeled and distributed by Amd Medicom Inc.. The primary component is Benzocaine; Tetracaine Hydrochloride.

Product ID64778-0393_5fb41378-aa0d-264b-e053-2991aa0aab3a
NDC64778-0393
Product TypeHuman Prescription Drug
Proprietary NameDenti-Care Denti-Freeze Topical Anesthetic Bubblegum
Generic NameBenzocaine, Tetracaine Hydrochloride
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2000-02-01
Marketing End Date2020-11-30
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameAMD Medicom Inc.
Substance NameBENZOCAINE; TETRACAINE HYDROCHLORIDE
Active Ingredient Strength0 g/g; g/g
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 FlagN

Packaging

NDC 64778-0393-3

40 TRAY in 1 CASE (64778-0393-3) > 12 JAR in 1 TRAY (64778-0393-2) > 28.4 g in 1 JAR (64778-0393-1)
Marketing Start Date2017-12-01
Marketing End Date2021-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64778-0393-2 [64778039302]

Denti-Care Denti-Freeze Topical Anesthetic Bubblegum GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-22
Marketing End Date2020-11-30

NDC 64778-0393-3 [64778039303]

Denti-Care Denti-Freeze Topical Anesthetic Bubblegum GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-01
Marketing End Date2020-11-30

NDC 64778-0393-1 [64778039301]

Denti-Care Denti-Freeze Topical Anesthetic Bubblegum GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-02-01
Marketing End Date2020-11-30

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE.18 g/g

OpenFDA Data

SPL SET ID:8489b2e8-4647-4838-88b9-817b59ef83b0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1547587
  • 1547589
  • 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 "Denti-Care Denti-Freeze Topical Anesthetic Bubblegum" or generic name "Benzocaine, Tetracaine Hydrochloride"

    NDCBrand NameGeneric Name
    64778-0493Denti-Care Denti-Freeze Topical Anesthetic BubblegumDenti-Care Denti-Freeze Topical Anesthetic Bubblegum
    64778-0393Denti-Care Denti-Freezebenzocaine, tetracaine hydrochloride
    64778-0394Denti-Care Denti-Freezebenzocaine, tetracaine hydrochloride
    64778-0396Denti-Care Denti-Freezebenzocaine, tetracaine hydrochloride
    64778-0398Denti-Care Denti-Freezebenzocaine, tetracaine hydrochloride
    64778-0399Denti-Care Denti-Freezebenzocaine, tetracaine hydrochloride

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