NDC 69498-003

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 ID69498-003_451e0d02-ea6a-4d56-b9e1-c65560358b2e
NDC69498-003
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 69498-003-30

30 g in 1 JAR (69498-003-30)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69498-003-30 [69498000330]

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:1d6a1182-ab63-460a-ab91-8d4c2ae5d01e
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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.