NDC 69498-004

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 ID69498-004_c533e4c6-86cf-48a9-93b8-6efda2e70b09
NDC69498-004
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 69498-004-30

30 g in 1 JAR (69498-004-30)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69498-004-30 [69498000430]

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:b0b3ab27-704a-44b8-8473-d21ac3359ba1
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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