Burn Relief
NDC Package 63868-784-04

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.

Burn Relief is • shake well• adults and children 2 years of age and older: apply to affected area, not more than 3 to 4 times daily• children under 2 years of age: ask a doctor• to apply to face, spray into palm of hand and gently apply. Marketed by Quality Choice, this product is identified by NDC 63868-784 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
63868-784-04
Package Description
127 g in 1 CAN
Product Code
63868-784
11-Digit Billing Format
63868078404
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Burn Relief
Dosage Form
-
Usage Information
• shake well• adults and children 2 years of age and older: apply to affected area, not more than 3 to 4 times daily• children under 2 years of age: ask a doctor• to apply to face, spray into palm of hand and gently apply

Regulatory & Marketing

Labeler Name
Quality Choice
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
04-17-2012
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 63868-784-04 identifies a specific commercial package of 127 g in 1 can of Burn Relief, labeled by Quality Choice. 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 Quality Choice on April 17, 2012. The current certification is valid through December 31, 2019.

How is this Quality Choice product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868078404. 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)
63868-784-04
11-Digit CMS (5-4-2)
63868-0784-04

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