NDC 64778-0398

Denti-Care Denti-Freeze Topical Anesthetic Raspberry

Benzocaine, Tetracaine Hydrochloride

Denti-Care Denti-Freeze Topical Anesthetic Raspberry 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 ID64778-0398_5fb74303-3199-738e-e053-2a91aa0a37cf
NDC64778-0398
Product TypeHuman Prescription Drug
Proprietary NameDenti-Care Denti-Freeze Topical Anesthetic Raspberry
Generic NameBenzocaine, Tetracaine Hydrochloride
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2005-04-01
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 64778-0398-3

40 TRAY in 1 CASE (64778-0398-3) > 12 JAR in 1 TRAY (64778-0398-2) > 28.4 g in 1 JAR (64778-0398-1)
Marketing Start Date2017-12-01
Marketing End Date2021-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64778-0398-2 [64778039802]

Denti-Care Denti-Freeze Topical Anesthetic Raspberry GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-20
Marketing End Date2020-11-30

NDC 64778-0398-3 [64778039803]

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

NDC 64778-0398-1 [64778039801]

Denti-Care Denti-Freeze Topical Anesthetic Raspberry GEL
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-04-01
Marketing End Date2020-11-30

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE.18 g/g

OpenFDA Data

SPL SET ID:70cda102-3564-4d25-adf7-93c83fac6b57
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 Raspberry" or generic name "Benzocaine, Tetracaine Hydrochloride"

    NDCBrand NameGeneric Name
    64778-0498Denti-Care Denti-Freeze Topical Anesthetic RaspberryDenti-Care Denti-Freeze Topical Anesthetic Raspberry
    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

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