Nuvira Patch
NDC Package 83295-3313-5

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

Nuvira (capsaicin 0.025%, menthol 10%, methyl nicotinate 0.25%, methyl salicylate 10%) patches is adults and Children 12 Years of Age and Older:Clean and dry the affected areaApply gel pad directly to your skin for up to 12 hoursGel pad can be cut into pieces and used on up to 2 body parts at a timeOne application per day is recommendedWash hands immediately after use. This formulation utilizes a patch delivery system. Marketed by Strand Health Group, this product is identified by NDC 83295-3313 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
83295-3313-5
Package Description
5 PATCH in 1 POUCH / 8.5 g in 1 PATCH
Product Code
83295-3313
11-Digit Billing Format
83295331305
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2640874 - capsaicin 0.025 % / menthol 10 % / methyl salicylate 10 % / methylnicotinate 0.25 % Medicated Patch
  • RxCUI: 2640874 - capsaicin 0.00025 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.1 MG/MG / methylnicotinate 0.0025 MG/MG Medicated Patch

Clinical Specifications

Proprietary Name
Nuvira
Non-Proprietary Name
Capsaicin 0.025%, Menthol 10%, Methyl Nicotinate 0.25%, Methyl Salicylate 10%
Substance Name
Capsaicin; Menthol; Methyl Nicotinate; Methyl Salicylate
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route
Cutaneous - Administration to the skin.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Adults and Children 12 Years of Age and Older:Clean and dry the affected areaApply gel pad directly to your skin for up to 12 hoursGel pad can be cut into pieces and used on up to 2 body parts at a timeOne application per day is recommendedWash hands immediately after use

Regulatory & Marketing

Labeler Name
Strand Health Group
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-29-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (83295-3313). Click a package code to view its specific billing and regulatory data.

83295-3313-1
6 POUCH in 1 BOX / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH

* 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 83295-3313-5 identifies a specific commercial package of 5 patch in 1 pouch / 8.5 g in 1 patch of Nuvira, a human over the counter drug labeled by Strand Health Group. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This patch is formulated for cutaneous use and contains capsaicin; menthol; methyl nicotinate; 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 June 29, 2023. 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: 83295331305. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
83295-3313-5
11-Digit CMS (5-4-2)
83295-3313-05

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