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  5. NDC Package Code: 55319-108-14 Family Wellness Oral Pain Relief

NDC Package 55319-108-14 Family Wellness Oral Pain Relief

Benzocaine 20% Gel Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
55319-108-14
Package Description:
1 TUBE in 1 CARTON / 14 g in 1 TUBE
Product Code:
55319-108
Proprietary Name:
Family Wellness Oral Pain Relief
Non-Proprietary Name:
Benzocaine 20%
Substance Name:
Benzocaine
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
11-Digit NDC Billing Format:
55319010814
NDC to RxNorm Crosswalk:
  • RxCUI: 238910 - benzocaine 20 % Oral Gel
  • RxCUI: 238910 - benzocaine 0.2 MG/MG Oral Gel
  • RxCUI: 238910 - benzocaine 20 % (180-220 MG per 1 GM) Oral Gel
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Family Dollar Services Inc
    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(s):
  • 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(es):
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M022
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    02-01-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 55319-108-14?

    The NDC Packaged Code 55319-108-14 is assigned to a 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. The product's dosage form is gel and is administered via topical form.

    Is NDC 55319-108 included in the NDC Directory?

    Yes, Family Wellness Oral Pain Relief with product code 55319-108 is active and included in the NDC Directory. The product was first marketed by Family Dollar Services Inc on February 01, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 55319-108-14?

    The 11-digit format is 55319010814. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-255319-108-145-4-255319-0108-14