Synoflex Patch
NDC Package 70512-015-15

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

Package Information

Synoflex Patch patches is adults and children over 12 years: Clean and dry the affected area Open pouch and remove one patchRemove the protective film from the patch and apply patch to the affected areaReseal pouch containing unused patches after each useUse 1 patch for up to 12 hoursChildren 12 years or younger: ask a doctor. This formulation utilizes a patch delivery system. Marketed by Sola Pharmaceuticals, this product is identified by NDC 70512-015 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
70512-015-15
Package Description
3 POUCH in 1 BOX / 5 g in 1 POUCH
Product Code
70512-015
11-Digit Billing Format
70512001515
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: 2600301 - lidocaine HCl 4 % / menthol 5 % Medicated Patch
  • RxCUI: 2600301 - lidocaine hydrochloride 0.04 MG/MG / menthol 0.05 MG/MG Medicated Patch

Clinical Specifications

Proprietary Name
Synoflex Patch
Non-Proprietary Name
Synoflex Patch
Substance Name
Lidocaine Hydrochloride; Menthol
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
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 over 12 years: Clean and dry the affected area Open pouch and remove one patchRemove the protective film from the patch and apply patch to the affected areaReseal pouch containing unused patches after each useUse 1 patch for up to 12 hoursChildren 12 years or younger: ask a doctor

Regulatory & Marketing

Labeler Name
Sola Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-28-2022
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 70512-015-15 identifies a specific commercial package of 3 pouch in 1 box / 5 g in 1 pouch of Synoflex Patch, a human over the counter drug labeled by Sola Pharmaceuticals. 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 topical use and contains lidocaine hydrochloride; menthol 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 Sola Pharmaceuticals on April 28, 2022. The current certification is valid through December 31, 2026.

How is this Sola Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70512001515. 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 (5-3-2)
70512-015-15
11-Digit CMS (5-4-2)
70512-0015-15

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