Quality Choice Maximum Strength Oral Pain Relieving Gel
NDC Package 63868-953-11

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

Package Information

Quality Choice Maximum Strength Oral Pain Relieving (benzocaine) gel is directionsremove cap and apply small amount of Oral Pain Relieving Gel to the cavity and around gum surrounding the teethadults and children 2 years of age and older: apply to the affected area up to 4 times daily or as directed by a doctor/dentistchildren under 12 years of age: should be supervised in the use of this productchildren under 2 years of age: ask a doctor/dentistFor denture Irritation: apply thin layer to the affected areado not reinsert denture work until irritation/pain is relievedrinse mouth well before reinserting. This formulation utilizes a gel delivery system. Marketed by Chain Drug Marketing Association Inc, this product is identified by NDC 63868-953 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
63868-953-11
Package Description
1 TUBE in 1 CARTON / 11.76 g in 1 TUBE
Product Code
63868-953
11-Digit Billing Format
63868095311
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
11.76 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Quality Choice Maximum Strength Oral Pain Relieving
Non-Proprietary Name
Benzocaine
Substance Name
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)
BENZOCAINE 20 g/100g
Pharmacologic Class
Usage Information
Directionsremove cap and apply small amount of Oral Pain Relieving Gel to the cavity and around gum surrounding the teethadults and children 2 years of age and older: apply to the affected area up to 4 times daily or as directed by a doctor/dentistchildren under 12 years of age: should be supervised in the use of this productchildren under 2 years of age: ask a doctor/dentistFor denture Irritation: apply thin layer to the affected areado not reinsert denture work until irritation/pain is relievedrinse mouth well before reinserting

Regulatory & Marketing

Labeler Name
Chain Drug Marketing Association Inc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-31-2013
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 63868-953-11 identifies a specific commercial package of 1 tube in 1 carton / 11.76 g in 1 tube of Quality Choice Maximum Strength Oral Pain Relieving, a human over the counter drug labeled by Chain Drug Marketing Association Inc. This product is billed per "GM" gram and contains an estimated amount of 11.76 billable units per package. This gel is formulated for topical use and contains 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 Chain Drug Marketing Association Inc on May 31, 2013. The current certification is valid through December 31, 2026.

How is this Chain Drug Marketing Association Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868095311. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 11.76 total billable units per package. 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)
63868-953-11
11-Digit CMS (5-4-2)
63868-0953-11

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