Oral Pain Relief Gel
NDC Package 57896-139-05

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

Package Information

Oral Pain Relief (benzocaine) gel is • do not exceed recommended dosage• do not use for more than 7 days unless told to do so by a dentist or doctor• adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist • children between 2 and 12 years of age: adult supervision should be given in use of this product • children under 2 years of age: do not use. This formulation utilizes a gel delivery system. Marketed by Geri-care Pharmaceutical Corp, this product is identified by NDC 57896-139 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
57896-139-05
Package Description
1 TUBE in 1 CARTON / 14.2 g in 1 TUBE
Product Code
57896-139
11-Digit Billing Format
57896013905
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
14.2 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oral Pain Relief
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BENZOCAINE 200 mg/g
Pharmacologic Class
Usage Information
• do not exceed recommended dosage• do not use for more than 7 days unless told to do so by a dentist or doctor• adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist • children between 2 and 12 years of age: adult supervision should be given in use of this product • children under 2 years of age: do not use

Regulatory & Marketing

Labeler Name
Geri-care Pharmaceutical Corp
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-01-2021
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 57896-139-05 identifies a specific commercial package of 1 tube in 1 carton / 14.2 g in 1 tube of Oral Pain Relief, a human over the counter drug labeled by Geri-care Pharmaceutical Corp. This product is billed per "GM" gram and contains an estimated amount of 14.2 billable units per package. This gel is formulated for oral 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 Geri-care Pharmaceutical Corp on March 01, 2021. The current certification is valid through December 31, 2026.

How is this Geri-care Pharmaceutical Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57896013905. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 14.2 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)
57896-139-05
11-Digit CMS (5-4-2)
57896-0139-05

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