Winco Foods Maximum Strength Oral Analgesic Gel
NDC Package 67091-198-11

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

Package Information

Winco Foods Maximum Strength Oral Analgesic (benzocaine) gel is directionsremove cap and cut tip of tube on score markadults an children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. This formulation utilizes a gel delivery system. Marketed by Winco Foods, Llc, this product is identified by NDC 67091-198 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
67091-198-11
Package Description
1 TUBE in 1 CARTON / 11.9 g in 1 TUBE
Product Code
67091-198
11-Digit Billing Format
67091019811
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Winco Foods Maximum Strength Oral Analgesic
Non-Proprietary Name
Benzocaine
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 200 mg/g
Pharmacologic Class
Usage Information
Directionsremove cap and cut tip of tube on score markadults an children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a doctor or dentistchildren under 12 years of age: should be supervised in the use of this productchildren under 2 years of age: ask a doctor/dentist

Regulatory & Marketing

Labeler Name
Winco Foods, Llc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-01-2014
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 67091-198-11 identifies a specific commercial package of 1 tube in 1 carton / 11.9 g in 1 tube of Winco Foods Maximum Strength Oral Analgesic, a human over the counter drug labeled by Winco Foods, Llc. 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 Winco Foods, Llc on December 01, 2014. The current certification is valid through December 31, 2026.

How is this Winco Foods, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67091019811. 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)
67091-198-11
11-Digit CMS (5-4-2)
67091-0198-11

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