Top Safety First Aid Burn Cream
NDC Package 51395-412-01

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.

Top Safety First Aid Burn Cream is adults and children 2 years and over:clean the affected areaapply a small amount of this product on the area 3 or 4 times daily.may be covered with a sterile bandageChildren under 2 yearsconsult a doctor. Marketed by Top Safety Products Company Inc, this product is identified by NDC 51395-412 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
51395-412-01
Package Description
2000 PACKET in 1 BOX / .9 g in 1 PACKET
Product Code
51395-412
11-Digit Billing Format
51395041201
RxNorm Crosswalk
  • RxCUI: 1012100 - benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream
  • RxCUI: 1012100 - benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream
  • RxCUI: 1012100 - benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream

Clinical Specifications

Proprietary Name
Top Safety First Aid Burn Cream
Dosage Form
-
Usage Information
Adults and children 2 years and over:clean the affected areaapply a small amount of this product on the area 3 or 4 times daily.may be covered with a sterile bandageChildren under 2 yearsconsult a doctor

Regulatory & Marketing

Labeler Name
Top Safety Products Company Inc
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
02-07-2016
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 51395-412-01 identifies a specific commercial package of 2000 packet in 1 box / .9 g in 1 packet of Top Safety First Aid Burn Cream, labeled by Top Safety Products Company 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 Top Safety Products Company Inc on February 07, 2016. The current certification is valid through December 31, 2020.

How is this Top Safety Products Company Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51395041201. 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)
51395-412-01
11-Digit CMS (5-4-2)
51395-0412-01

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