Oral Pain Relief
NDC Package 67510-0058-4

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 do not use if tube tip is cut prior to opening; cut open tip of tube on score mark Adults and children 2 years of age and over Apply a small amount of product to the cavity and around gum surrounding the teeth. Marketed by Kareway Product, Inc., this product is identified by NDC 67510-0058 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
67510-0058-4
Package Description
1 TUBE in 1 CARTON / 11.9 g in 1 TUBE
Product Code
67510-0058
11-Digit Billing Format
67510005804
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oral Pain Relief
Dosage Form
-
Usage Information
Directions do not use if tube tip is cut prior to opening; cut open tip of tube on score mark Adults and children 2 years of age and over Apply 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 doctor Children under 12 years of age Should be supervised in the use of this product Children under 2 years of age Ask a dentist or doctor Other information This preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can be consulted; do not use continuously

Regulatory & Marketing

Labeler Name
Kareway Product, 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
07-17-2011
Listing Expiration
12-31-2019
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 67510-0058-4 identifies a specific commercial package of 1 tube in 1 carton / 11.9 g in 1 tube of Oral Pain Relief, labeled by Kareway Product, 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 Kareway Product, Inc. on July 17, 2011. The current certification is valid through December 31, 2019.

How is this Kareway Product, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67510005804. 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 (5-4-1)
67510-0058-4
11-Digit CMS (5-4-2)
67510-0058-04

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