Family Wellness Cold Hot
NDC Package 55319-208-01

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.

Family Wellness Cold Hot is directionsopen pouch and remove patchcarefully peel off protective backing and apply sticky side to affected areaadults and children 12 years of age and olderdo not wear patch for more than 8 hoursapply to affected area no more than 3 times dailychildren under 12 years of age: consult a doctor. Marketed by Family Dollar Services, Inc., this product is identified by NDC 55319-208 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
55319-208-01
Package Description
1 PATCH in 1 POUCH / 1 PATCH in 1 PATCH
Product Code
55319-208
11-Digit Billing Format
55319020801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Family Wellness Cold Hot
Dosage Form
-
Usage Information
Directionsopen pouch and remove patchcarefully peel off protective backing and apply sticky side to affected areaadults and children 12 years of age and olderdo not wear patch for more than 8 hoursapply to affected area no more than 3 times dailychildren under 12 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Family Dollar Services, Inc.
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
11-07-2019
Listing Expiration
12-31-2024
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 55319-208-01 identifies a specific commercial package of 1 patch in 1 pouch / 1 patch in 1 patch of Family Wellness Cold Hot, labeled by Family Dollar Services, Inc.. 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 Family Dollar Services, Inc. on November 07, 2019. The current certification is valid through December 31, 2024.

How is this Family Dollar Services, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55319020801. 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)
55319-208-01
11-Digit CMS (5-4-2)
55319-0208-01

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