NDC 64778-0399

Denti-Care Denti-Freeze Topical Anesthetic Strawberry

Benzocaine, Tetracaine Hydrochloride

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

Product ID64778-0399_4776a475-535d-4bcf-b7d6-eb1d68094bd2
NDC64778-0399
Product TypeHuman Prescription Drug
Proprietary NameDenti-Care Denti-Freeze Topical Anesthetic Strawberry
Generic NameBenzocaine, Tetracaine Hydrochloride
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2000-02-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameAR 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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 64778-0399-3

40 TRAY in 1 CASE (64778-0399-3) > 12 JAR in 1 TRAY (64778-0399-2) > 28.4 g in 1 JAR (64778-0399-1)
Marketing Start Date2017-12-01
Marketing End Date2021-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64778-0399-3 [64778039903]

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

NDC 64778-0399-1 [64778039901]

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

NDC 64778-0399-2 [64778039902]

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

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE.18 g/g

OpenFDA Data

SPL SET ID:6ac9623e-35d5-45a7-8a13-0f00c13b4527
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 Strawberry" or generic name "Benzocaine, Tetracaine Hydrochloride"

    NDCBrand NameGeneric Name
    64778-0499Denti-Care Denti-Freeze Topical Anesthetic StrawberryDenti-Care Denti-Freeze Topical Anesthetic Strawberry
    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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