Oralabs Cold Sore Treatment
NDC Package 63645-162-04

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.

Oralabs Cold Sore Treatment is clean the affected Adults and children 2 years of age and older: Apply to affected area not more than 4 times dailyChildren under 2 years of age: consult a physicianRub in gently – Applies clearWash hands before and after applying creamDo not share this product with anyone. Marketed by Oralabs, this product is identified by NDC 63645-162 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
63645-162-04
Package Description
1 g in 1 CONTAINER
Product Code
63645-162
11-Digit Billing Format
63645016204

Clinical Specifications

Proprietary Name
Oralabs Cold Sore Treatment
Dosage Form
-
Usage Information
Clean the affected Adults and children 2 years of age and older: Apply to affected area not more than 4 times dailyChildren under 2 years of age: consult a physicianRub in gently – Applies clearWash hands before and after applying creamDo not share this product with anyone

Regulatory & Marketing

Labeler Name
Oralabs
FDA Application #
part348
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
08-01-2014
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 63645-162-04 identifies a specific commercial package of 1 g in 1 container of Oralabs Cold Sore Treatment, labeled by Oralabs. 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 Oralabs on August 01, 2014. The current certification is valid through December 31, 2019.

How is this Oralabs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63645016204. 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)
63645-162-04
11-Digit CMS (5-4-2)
63645-0162-04

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