Diclona Gel
NDC Package 80425-0517-1

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

Package Information

Diclona (lidocaine 4.5%, diclofenac 1%) gel is diclona™is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. This formulation utilizes a gel delivery system. Marketed by Advanced Rx Of Tennessee, Llc, this product is identified by NDC 80425-0517.

Identification & Billing

NDC Package Code
80425-0517-1
Package Description
99 g in 1 TUBE
Product Code
80425-0517
11-Digit Billing Format
80425051701
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
99 GM
RxNorm Crosswalk
  • RxCUI: 2600049 - diclofenac sodium 1 % / lidocaine HCl 4.5 % Topical Gel
  • RxCUI: 2600049 - diclofenac sodium 0.01 MG/MG / lidocaine hydrochloride 0.045 MG/MG Topical Gel

Clinical Specifications

Proprietary Name
Diclona
Non-Proprietary Name
Lidocaine 4.5%, Diclofenac 1%
Substance Name
Diclofenac Sodium; Lidocaine
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
Cutaneous - Administration to the skin.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Diclona™is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. Diclona Gel is contraindicated in patients with a known hypersensitivity to diclofenac sodium. Diclona Gel is contraindicated in patients in the setting of coronary artery bypass graft (CABG) surgery.

Regulatory & Marketing

Labeler Name
Advanced Rx Of Tennessee, Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
05-05-2025
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80425-0517-1 identifies a specific commercial package of 99 g in 1 tube of Diclona, a human prescription drug labeled by Advanced Rx Of Tennessee, Llc. This product is billed per "GM" gram and contains an estimated amount of 99 billable units per package. This gel is formulated for cutaneous use and contains diclofenac sodium; lidocaine 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 Advanced Rx Of Tennessee, Llc on May 05, 2025. The current certification is valid through December 31, 2026.

How is this Advanced Rx Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425051701. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 99 total billable units per package. 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 (5-4-1)
80425-0517-1
11-Digit CMS (5-4-2)
80425-0517-01

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