Dzul Fast Freeze Spray
NDC Package 83037-105-04

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

Package Information

Dzul Fast Freeze (menthol) sprays is adults and Children over 12 years of ageSpray two to three pumps or as necessary to cover the affected area not more than three to four times daily.Children under 12 years of age: do not use, consult a doctor. This formulation utilizes a spray delivery system. Marketed by Caball Sales, Inc., this product is identified by NDC 83037-105 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
83037-105-04
Package Description
118 mL in 1 BOTTLE, SPRAY
Product Code
83037-105
11-Digit Billing Format
83037010504

Clinical Specifications

Proprietary Name
Dzul Fast Freeze Instant Pain Relief
Non-Proprietary Name
Menthol
Substance Name
Menthol
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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)
MENTHOL 9 g/100mL
Usage Information
Adults and Children over 12 years of ageSpray two to three pumps or as necessary to cover the affected area not more than three to four times daily.Children under 12 years of age: do not use, consult a doctor.

Regulatory & Marketing

Labeler Name
Caball Sales, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-30-2024
End Marketing Date
06-27-2026
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 83037-105-04 identifies a specific commercial package of 118 ml in 1 bottle, spray of Dzul Fast Freeze Instant Pain Relief, a human over the counter drug labeled by Caball Sales, Inc.. This spray is formulated for topical use and contains menthol 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 Caball Sales, Inc. on June 30, 2024.

How is this Caball Sales, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83037010504. 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)
83037-105-04
11-Digit CMS (5-4-2)
83037-0105-04

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