NDC 68400-323

Gelato Topical Anesthetic

Benzocaine

Gelato Topical Anesthetic is a Dental Spray, Metered in the Human Otc Drug category. It is labeled and distributed by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. The primary component is Benzocaine.

Product ID68400-323_9e594fb8-9900-47fa-af92-218fb6c85be2
NDC68400-323
Product TypeHuman Otc Drug
Proprietary NameGelato Topical Anesthetic
Generic NameBenzocaine
Dosage FormSpray, Metered
Route of AdministrationDENTAL
Marketing Start Date2013-07-29
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Substance NameBENZOCAINE
Active Ingredient Strength11 g/57g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68400-323-35

57 g in 1 BOTTLE, SPRAY (68400-323-35)
Marketing Start Date2018-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68400-323-35 [68400032335]

Gelato Topical Anesthetic SPRAY, METERED
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE11.4 g/57g

OpenFDA Data

SPL SET ID:9991de96-99a1-42f0-9ddd-e530ca9ceab1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1435490
  • 1435495

    • NDC Crossover Matching brand name "Gelato Topical Anesthetic" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    68400-355Gelato Topical AnestheticGelato Topical Anesthetic
    68400-351Gelato Topical AnestheticGelato Topical Anesthetic
    68400-350Gelato Topical AnestheticGelato Topical Anesthetic
    68400-352Gelato Topical AnestheticGelato Topical Anesthetic
    68400-356Gelato Topical AnestheticGelato Topical Anesthetic
    68400-323Gelato Topical AnestheticGelato Topical Anesthetic
    68400-354Gelato Topical AnestheticGelato Topical Anesthetic
    68400-359Gelato Topical AnestheticGelato Topical Anesthetic
    68400-357Gelato Topical AnestheticGelato Topical Anesthetic
    68400-353Gelato Topical AnestheticGelato Topical Anesthetic
    68400-358Gelato Topical AnestheticGelato 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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