Family Wellness Plus Pain Relief
NDC Package 69396-043-01

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 Plus Pain Relief is clean the affected area and dry thoroughlyApply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times dailyMay be covered with a sterile bandage. Marketed by Trifecta Pharmaceutical Usa Llc, this product is identified by NDC 69396-043 and is authorized under FDA application part333B.

Identification & Billing

NDC Package Code
69396-043-01
Package Description
1 TUBE in 1 BOX / 28.4 g in 1 TUBE
Product Code
69396-043
11-Digit Billing Format
69396004301
RxNorm Crosswalk
  • RxCUI: 1359360 - neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream
  • RxCUI: 1359360 - neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream
  • RxCUI: 1359360 - neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical Cream
  • RxCUI: 1359360 - neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream

Clinical Specifications

Proprietary Name
Family Wellness Plus Pain Relief
Dosage Form
-
Usage Information
Clean the affected area and dry thoroughlyApply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times dailyMay be covered with a sterile bandage

Regulatory & Marketing

Labeler Name
Trifecta Pharmaceutical Usa Llc
FDA Application #
part333B
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-30-2019
Listing Expiration
12-31-2020
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 69396-043-01 identifies a specific commercial package of 1 tube in 1 box / 28.4 g in 1 tube of Family Wellness Plus Pain Relief, labeled by Trifecta Pharmaceutical Usa Llc. 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 Trifecta Pharmaceutical Usa Llc on August 30, 2019. The current certification is valid through December 31, 2020.

How is this Trifecta Pharmaceutical Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69396004301. 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)
69396-043-01
11-Digit CMS (5-4-2)
69396-0043-01

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