Gumsol Spray
NDC Package 52083-714-01

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

Package Information

Gumsol (benzocaine, zinc chloride) sprays is other information Phenylketonurics: Contains phenylalanine 2.5 mg/mLStore at controlled room temperature 15-30°C (59-86°F).Tamper Evident Feature: Do not use if imprinted foil seal over bottle opening is torn, broken, or missing. This formulation utilizes a spray delivery system. Marketed by Kramer Novis, this product is identified by NDC 52083-714 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
52083-714-01
Package Description
30 mL in 1 BOTTLE
Product Code
52083-714
11-Digit Billing Format
52083071401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML
RxNorm Crosswalk
  • RxCUI: 485558 - benzocaine 5 % / zinc chloride 0.1 % Mucosal Spray
  • RxCUI: 485558 - benzocaine 50 MG/ML / zinc chloride 1 MG/ML Mucosal Spray

Clinical Specifications

Proprietary Name
Gumsol
Non-Proprietary Name
Benzocaine, Zinc Chloride
Substance Name
Benzocaine; Zinc Chloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Other information Phenylketonurics: Contains phenylalanine 2.5 mg/mLStore at controlled room temperature 15-30°C (59-86°F).Tamper Evident Feature: Do not use if imprinted foil seal over bottle opening is torn, broken, or missing.

Regulatory & Marketing

Labeler Name
Kramer Novis
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-28-2014
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 52083-714-01 identifies a specific commercial package of 30 ml in 1 bottle of Gumsol, a human over the counter drug labeled by Kramer Novis. This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package. This spray is formulated for oral use and contains benzocaine; zinc chloride 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 Kramer Novis on February 28, 2014. The current certification is valid through December 31, 2026.

How is this Kramer Novis product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52083071401. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 total billable units per package. 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)
52083-714-01
11-Digit CMS (5-4-2)
52083-0714-01

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