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  5. NDC Package Code: 68400-359-30 Gelato Topical Anesthetic

NDC Package 68400-359-30 Gelato Topical Anesthetic

Benzocaine Gel Dental - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68400-359-30
Package Description:
30 g in 1 JAR
Product Code:
68400-359
Proprietary Name:
Gelato Topical Anesthetic
Non-Proprietary Name:
Benzocaine
Substance Name:
Benzocaine
Usage Information:
Apply only amount needed to the oral mucosa to prevent or relieve pain.
11-Digit NDC Billing Format:
68400035930
NDC to RxNorm Crosswalk:
  • RxCUI: 238910 - benzocaine 20 % Oral Gel
  • RxCUI: 238910 - benzocaine 0.2 MG/MG Oral Gel
  • RxCUI: 238910 - benzocaine 20 % (180-220 MG per 1 GM) Oral Gel
  • RxCUI: 727988 - Gelato Anesthetic 20 % Oral Gel
  • RxCUI: 727988 - benzocaine 0.2 MG/MG Oral Gel [Gelato Anesthetic]
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • BENZOCAINE 200 mg/g
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M022
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    07-01-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68400-359-30?

    The NDC Packaged Code 68400-359-30 is assigned to a package of 30 g in 1 jar of Gelato Topical Anesthetic, a human over the counter drug labeled by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. The product's dosage form is gel and is administered via dental form.

    Is NDC 68400-359 included in the NDC Directory?

    Yes, Gelato Topical Anesthetic with product code 68400-359 is active and included in the NDC Directory. The product was first marketed by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc on July 01, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68400-359-30?

    The 11-digit format is 68400035930. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268400-359-305-4-268400-0359-30