NDC 64522-004

VistaCaine Topical Anesthetic

Benzocaine

VistaCaine Topical Anesthetic is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Inter-med, Inc.. The primary component is Benzocaine.

Product ID64522-004_d658d6c6-e004-5083-e053-2a95a90a1a1f
NDC64522-004
Product TypeHuman Otc Drug
Proprietary NameVistaCaine Topical Anesthetic
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2018-02-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameInter-Med, INC.
Substance NameBENZOCAINE
Active Ingredient Strength200 mg/g
Pharm ClassesAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 64522-004-30

30 g in 1 JAR (64522-004-30)
Marketing Start Date2018-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64522-004-30 [64522000430]

VistaCaine Topical Anesthetic GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-02-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:632c9ed0-3b9b-4fa8-817e-c4ac7e21ad59
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238910
  • 2002727
  • NDC Crossover Matching brand name "VistaCaine Topical Anesthetic" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    64522-001VistaCaine Topical AnestheticVistaCaine Topical Anesthetic
    64522-002VistaCaine Topical AnestheticVistaCaine Topical Anesthetic
    64522-003VistaCaine Topical AnestheticVistaCaine Topical Anesthetic
    64522-004VistaCaine Topical AnestheticVistaCaine Topical Anesthetic
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE

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