NDC 69498-005

iSmile Topical Anesthetic

Benzocaine

iSmile Topical Anesthetic is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Ismile Dental Products, Inc.. The primary component is Benzocaine.

Product ID69498-005_b4ef8643-a29b-4343-b13a-bafa98f56eb1
NDC69498-005
Product TypeHuman Otc Drug
Proprietary NameiSmile Topical Anesthetic
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2014-06-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameiSmile Dental Products, Inc.
Substance NameBENZOCAINE
Active Ingredient Strength200 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69498-005-30

30 g in 1 JAR (69498-005-30)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69498-005-30 [69498000530]

iSmile Topical Anesthetic GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:d3b6669e-479f-4bc1-b533-5e9a0cc65213
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238910

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

    NDCBrand NameGeneric Name
    69498-002iSmile Topical AnestheticiSmile Topical Anesthetic
    69498-004iSmile Topical AnestheticiSmile Topical Anesthetic
    69498-001iSmile Topical AnestheticiSmile Topical Anesthetic
    69498-005iSmile Topical AnestheticiSmile Topical Anesthetic
    69498-006iSmile Topical AnestheticiSmile Topical Anesthetic
    69498-003iSmile Topical AnestheticiSmile 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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