Mouth Sore Medication
NDC Package 35418-631-01

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.

Mouth Sore Medication is adults and children 2 years and older: dry affected area and apply medication. Marketed by Zee Medical, this product is identified by NDC 35418-631 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
35418-631-01
Package Description
25 PACKET in 1 BOX / .5 g in 1 PACKET
Product Code
35418-631
11-Digit Billing Format
35418063101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mouth Sore Medication
Dosage Form
-
Usage Information
Adults and children 2 years and older: dry affected area and apply medication. Use up to 4 times daily, but not more than every 2 hours, 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

Regulatory & Marketing

Labeler Name
Zee Medical
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
05-01-2010
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 35418-631-01 identifies a specific commercial package of 25 packet in 1 box / .5 g in 1 packet of Mouth Sore Medication, labeled by Zee Medical. 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 Zee Medical on May 01, 2010. The current certification is valid through December 31, 2019.

How is this Zee Medical product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35418063101. 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)
35418-631-01
11-Digit CMS (5-4-2)
35418-0631-01

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