Oral Pain Relief
NDC Package 53943-996-42

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Oral Pain Relief is directions cut open tip of tube Adults and children 2 years of age and overApply a small amount of product to the cavity and around gum surrounding the teeth. Marketed by Discount Drug Mart, Inc., this product is identified by NDC 53943-996 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
53943-996-42
Package Description
1 TUBE in 1 CARTON / 11.9 g in 1 TUBE
Product Code
53943-996
11-Digit Billing Format
53943099642
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oral Pain Relief
Dosage Form
-
Usage Information
Directions cut open tip of tube Adults and children 2 years of age and overApply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctorChildren under 12 years of ageShould be supervised in the use of this productChildren under 2 years of ageAsk a dentist or doctor

Regulatory & Marketing

Labeler Name
Discount Drug Mart, Inc.
FDA Application #
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
11-09-2015
Listing Expiration
12-31-2020
Exclude Flag
I
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 53943-996-42 identifies a specific commercial package of 1 tube in 1 carton / 11.9 g in 1 tube of Oral Pain Relief, labeled by Discount Drug Mart, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Discount Drug Mart, Inc. on November 09, 2015. The current certification is valid through December 31, 2020.

How is this Discount Drug Mart, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53943099642. 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)
53943-996-42
11-Digit CMS (5-4-2)
53943-0996-42

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