Family Wellness Gel
NDC Package 55319-108-14

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

Package Information

Family Wellness (benzocaine 20%) gel is adults and children 2 years of age and overapply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentistchildren under 12 years of ageadult supervision should be given in the use of this productchildren under 2 years of agedo not useFor denture irritation:apply thin layer to the affected areado not reinsert dental work until irritation/pain is relievedrinse mouth well before reinserting. This formulation utilizes a gel delivery system. Marketed by Family Dollar Services Inc, this product is identified by NDC 55319-108 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
55319-108-14
Package Description
1 TUBE in 1 CARTON / 14 g in 1 TUBE
Product Code
55319-108
11-Digit Billing Format
55319010814
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Family Wellness Oral Pain Relief
Non-Proprietary Name
Benzocaine 20%
Substance Name
Benzocaine
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
BENZOCAINE .2 g/g
Pharmacologic Class
Usage Information
Adults and children 2 years of age and overapply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentistchildren under 12 years of ageadult supervision should be given in the use of this productchildren under 2 years of agedo not useFor denture irritation:apply thin layer to the affected areado not reinsert dental work until irritation/pain is relievedrinse mouth well before reinserting

Regulatory & Marketing

Labeler Name
Family Dollar Services Inc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-01-2024
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 55319-108-14 identifies a specific commercial package of 1 tube in 1 carton / 14 g in 1 tube of Family Wellness Oral Pain Relief, a human over the counter drug labeled by Family Dollar Services Inc. This gel is formulated for topical use and contains benzocaine 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 Family Dollar Services Inc on February 01, 2024. The current certification is valid through December 31, 2026.

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: 55319010814. 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)
55319-108-14
11-Digit CMS (5-4-2)
55319-0108-14

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