NDC 64778-0499

Denti-Care Denti-Freeze Topical Anesthetic Strawberry

Benzocaine

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

Product ID64778-0499_7e969d7d-af19-3497-e053-2a91aa0adf29
NDC64778-0499
Product TypeHuman Prescription Drug
Proprietary NameDenti-Care Denti-Freeze Topical Anesthetic Strawberry
Generic NameBenzocaine
Dosage FormOintment
Route of AdministrationDENTAL
Marketing Start Date2005-07-28
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameAMD Medicom Inc.
Substance NameBENZOCAINE
Active Ingredient Strength0 g/mL
Pharm ClassesStandardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64778-0499-3

40 TRAY in 1 CASE (64778-0499-3) > 12 JAR in 1 TRAY (64778-0499-2) > 29.6 mL in 1 JAR (64778-0499-1)
Marketing Start Date2017-12-01
Marketing End Date2021-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64778-0499-2 [64778049902]

Denti-Care Denti-Freeze Topical Anesthetic Strawberry OINTMENT
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-20

NDC 64778-0499-1 [64778049901]

Denti-Care Denti-Freeze Topical Anesthetic Strawberry OINTMENT
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-07-28

NDC 64778-0499-3 [64778049903]

Denti-Care Denti-Freeze Topical Anesthetic Strawberry OINTMENT
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE.2 g/mL

OpenFDA Data

SPL SET ID:d2a5fb23-313a-4093-8967-13559bca5999
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 244323
  • 991037

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Denti-Care Denti-Freeze Topical Anesthetic Strawberry" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    64778-0499Denti-Care Denti-Freeze Topical Anesthetic StrawberryDenti-Care Denti-Freeze Topical Anesthetic Strawberry
    64778-0399Denti-Care Denti-Freeze Topical Anesthetic StrawberryDenti-Care Denti-Freeze Topical Anesthetic Strawberry
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.