Flexin
NDC Package 69695-1974-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Flexin is adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily.Children under 12 years, consult a physician before use.How to apply:Clean and dry affected area.Cut open pouch and remove patch. Marketed by Whyteman Labs Llc, this product is identified by NDC 69695-1974 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
69695-1974-1
Package Description
15 POUCH in 1 BOX / 5 PATCH in 1 POUCH
Product Code
69695-1974
11-Digit Billing Format
69695197401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
15 EA
RxNorm Crosswalk
  • RxCUI: 1300889 - capsaicin 0.0375 % / menthol 5 % Medicated Patch
  • RxCUI: 1300889 - capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG Medicated Patch

Clinical Specifications

Proprietary Name
Flexin
Dosage Form
-
Usage Information
Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily.Children under 12 years, consult a physician before use.How to apply:Clean and dry affected area.Cut open pouch and remove patch. Remove protective film and apply directly to area of pain.Apply to affected area not more than 3 times daily.Wash hands with soap after applying patch.Reseal pouch containing unused patches.

Regulatory & Marketing

Labeler Name
Whyteman Labs Llc
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
07-13-2015
Listing Expiration
12-31-2017
Exclude Flag
I
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 69695-1974-1 identifies a specific commercial package of 15 pouch in 1 box / 5 patch in 1 pouch of Flexin, labeled by Whyteman Labs Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 15 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Whyteman Labs Llc on July 13, 2015. The current certification is valid through December 31, 2017.

How is this Whyteman Labs Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69695197401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 15 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)
69695-1974-1
11-Digit CMS (5-4-2)
69695-1974-01

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