NDC 69004-001

GPS Topical Anesthetic

Benzocaine

GPS Topical Anesthetic is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Group Practice Solutions, Inc.. The primary component is Benzocaine.

Product ID69004-001_d5f4ec89-a2a2-7062-e053-2a95a90a7ca3
NDC69004-001
Product TypeHuman Otc Drug
Proprietary NameGPS Topical Anesthetic
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2013-07-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameGroup Practice Solutions, 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 69004-001-30

30 g in 1 JAR (69004-001-30)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69004-001-30 [69004000130]

GPS Topical Anesthetic GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:a80cfd29-8314-4639-a811-afd5fdb630b0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238910
  • NDC Crossover Matching brand name "GPS Topical Anesthetic" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    69004-004GPS Topical AnestheticGPS Topical Anesthetic
    69004-005GPS Topical AnestheticGPS Topical Anesthetic
    69004-002GPS Topical AnestheticGPS Topical Anesthetic
    69004-001GPS Topical AnestheticGPS Topical Anesthetic
    69004-003GPS Topical AnestheticGPS Topical Anesthetic
    69004-006GPS Topical AnestheticGPS 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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