Careone Arthritis Pain Relief Gel
NDC Package 41520-788-01

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

Package Information

Careone Arthritis Pain Relief (diclofenac sodium) gel is diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. This formulation utilizes a gel delivery system. Marketed by American Sales Company, this product is identified by NDC 41520-788 and is authorized under FDA application ANDA211253.

Identification & Billing

NDC Package Code
41520-788-01
Package Description
1 TUBE, WITH APPLICATOR in 1 CARTON / 100 g in 1 TUBE, WITH APPLICATOR
Product Code
41520-788
11-Digit Billing Format
41520078801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Careone Arthritis Pain Relief
Non-Proprietary Name
Diclofenac Sodium
Substance Name
Diclofenac Sodium
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)
DICLOFENAC SODIUM 10 mg/g
Pharmacologic Class
Usage Information
Diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

Regulatory & Marketing

Labeler Name
American Sales Company
Product Type
Human Otc Drug
FDA Application #
ANDA211253
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-29-2020
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 41520-788-01 identifies a specific commercial package of 1 tube, with applicator in 1 carton / 100 g in 1 tube, with applicator of Careone Arthritis Pain Relief, a human over the counter drug labeled by American Sales Company. This gel is formulated for topical use and contains diclofenac sodium 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 American Sales Company on October 29, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

How is this American Sales Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41520078801. 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)
41520-788-01
11-Digit CMS (5-4-2)
41520-0788-01

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