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  5. NDC Package Code: 83650-101-01 Oral Gel Oral Pain Relief

NDC Package 83650-101-01 Oral Gel Oral Pain Relief

Benzocaine Benzalkonium Chloride Gel Topical - 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:
83650-101-01
Package Description:
42.5 g in 1 TUBE
Product Code:
83650-101
Proprietary Name:
Oral Gel Oral Pain Relief
Non-Proprietary Name:
Benzocaine Benzalkonium Chloride
Substance Name:
Benzalkonium Chloride; Benzocaine
Usage Information:
■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider ■ children under 12 years: should be supervised in the use of this product ■ children under 2 years of age: ask a physician or health care provider
11-Digit NDC Billing Format:
83650010101
NDC to RxNorm Crosswalk:
  • RxCUI: 1595155 - benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel
  • RxCUI: 1595155 - benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel
  • RxCUI: 1595155 - benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Savvy Care And Cosmetics
    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):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • BENZALKONIUM CHLORIDE .1 g/100g
  • BENZOCAINE 20 g/100g
    • 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:
    part356
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    09-22-2023
    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 83650-101-01?

    The NDC Packaged Code 83650-101-01 is assigned to a package of 42.5 g in 1 tube of Oral Gel Oral Pain Relief, a human over the counter drug labeled by Savvy Care And Cosmetics. The product's dosage form is gel and is administered via topical form.

    Is NDC 83650-101 included in the NDC Directory?

    Yes, Oral Gel Oral Pain Relief with product code 83650-101 is active and included in the NDC Directory. The product was first marketed by Savvy Care And Cosmetics on September 22, 2023 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 83650-101-01?

    The 11-digit format is 83650010101. 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
    5-3-283650-101-015-4-283650-0101-01