Oral Gel
NDC Package 83650-101-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Oral Gel (benzocaine benzalkonium chloride) gel is ■ 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. This formulation utilizes a gel delivery system. Marketed by Savvy Care And Cosmetics, this product is identified by NDC 83650-101 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
83650-101-01
Package Description
42.5 g in 1 TUBE
Product Code
83650-101
11-Digit Billing Format
83650010101
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

Clinical Specifications

Proprietary Name
Oral Gel Oral Pain Relief
Non-Proprietary Name
Benzocaine Benzalkonium Chloride
Substance Name
Benzalkonium Chloride; Benzocaine
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
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)
Pharmacologic Class
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

Regulatory & Marketing

Labeler Name
Savvy Care And Cosmetics
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-22-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83650-101-01 identifies a specific commercial 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. This gel is formulated for topical use and contains benzalkonium chloride; benzocaine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Savvy Care And Cosmetics on September 22, 2023. The current certification is valid through December 31, 2026.

How is this Savvy Care And Cosmetics product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83650010101. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83650-101-01
11-Digit CMS (5-4-2)
83650-0101-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.