Diabetic First Aid Gel
NDC Package 71521-390-15

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Diabetic First Aid Gel (benzalkonium chloride, lidocaine hydrochloride) gel is adults and children 12 years of age and older:clean the affected areaapply a small amount of this product on the area 1 to 3 times dailymay be covered with a sterile bandageif bandaged, let dry firstChildren under 12 years of age: consult a doctor. This formulation utilizes a gel delivery system. Marketed by Lavior Pharma Inc., this product is identified by NDC 71521-390 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
71521-390-15
Package Description
15 g in 1 TUBE
Product Code
71521-390
11-Digit Billing Format
71521039015
RxNorm Crosswalk
  • RxCUI: 2535510 - benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Gel
  • RxCUI: 2535510 - benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.005 MG/MG Topical Gel

Clinical Specifications

Proprietary Name
Diabetic First Aid Gel
Non-Proprietary Name
Benzalkonium Chloride, Lidocaine Hydrochloride
Substance Name
Benzalkonium Chloride; Lidocaine Hydrochloride
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Adults and children 12 years of age and older:clean the affected areaapply a small amount of this product on the area 1 to 3 times dailymay be covered with a sterile bandageif bandaged, let dry firstChildren under 12 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Lavior Pharma Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-31-2021
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71521-390). Click a package code to view its specific billing and regulatory data.

71521-390-30
30 g in 1 TUBE
71521-390-50
50 g in 1 BOTTLE, PUMP

* 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 71521-390-15 identifies a specific commercial package of 15 g in 1 tube of Diabetic First Aid Gel, a human over the counter drug labeled by Lavior Pharma Inc.. This gel is formulated for topical use and contains benzalkonium chloride; lidocaine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Lavior Pharma Inc. on March 31, 2021. The current certification is valid through December 31, 2027.

How is this Lavior Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71521039015. 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)
71521-390-15
11-Digit CMS (5-4-2)
71521-0390-15

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