Xiclofen Ointment
NDC Package 83295-5050-1

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

Package Information

Xiclofen (diclofenac sodium, methyl salicylate) ointment is xiclofen TM Ointment is indicated in adults over the age of 12 years old for the treatment of signs and symptoms of osteoarthritis of the joints, and of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more. This formulation utilizes a ointment delivery system. Marketed by Strand Health Group, this product is identified by NDC 83295-5050.

Identification & Billing

NDC Package Code
83295-5050-1
Package Description
1 TUBE in 1 BOX / 85 g in 1 TUBE
Product Code
83295-5050
11-Digit Billing Format
83295505001
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
85 GM
RxNorm Crosswalk
  • RxCUI: 2704846 - diclofenac sodium 1 % / methyl salicylate 5 % Topical Ointment
  • RxCUI: 2704846 - diclofenac sodium 0.01 MG/MG / methyl salicylate 0.05 MG/MG Topical Ointment

Clinical Specifications

Proprietary Name
Xiclofen
Non-Proprietary Name
Diclofenac Sodium, Methyl Salicylate
Substance Name
Diclofenac Sodium; Methyl Salicylate
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Cutaneous - Administration to the skin.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Xiclofen TM Ointment is indicated in adults over the age of 12 years old for the treatment of signs and symptoms of osteoarthritis of the joints, and of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.

Regulatory & Marketing

Labeler Name
Strand Health Group
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
02-07-2025
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 83295-5050-1 identifies a specific commercial package of 1 tube in 1 box / 85 g in 1 tube of Xiclofen, a human prescription drug labeled by Strand Health Group. This product is billed per "GM" gram and contains an estimated amount of 85 billable units per package. This ointment is formulated for cutaneous use and contains diclofenac sodium; methyl salicylate 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 Strand Health Group on February 07, 2025. The current certification is valid through December 31, 2026.

How is this Strand Health Group product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83295505001. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 85 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)
83295-5050-1
11-Digit CMS (5-4-2)
83295-5050-01

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