Fire Out Solution
NDC Package 52412-300-10

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

Package Information

Fire Out (benzocaine and menthol) solution is children under 2 yrs.▪Do not use▪Consult doctorAdults and children 2 yrs. This formulation utilizes a solution delivery system. Marketed by Randob Ltd., this product is identified by NDC 52412-300 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
52412-300-10
Package Description
1 BOTTLE, WITH APPLICATOR in 1 CARTON / 50 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
52412-300
11-Digit Billing Format
52412030010
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fire Out
Non-Proprietary Name
Benzocaine And Menthol
Substance Name
Benzocaine; Menthol, Unspecified Form
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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)
Pharmacologic Class
Usage Information
Children under 2 yrs.▪Do not use▪Consult doctorAdults and children 2 yrs. and older▪Clean area▪Apply to affected area as needed not more than 3 to 4 times a day.

Regulatory & Marketing

Labeler Name
Randob Ltd.
Product Type
Human Otc Drug
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
02-15-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52412-300). Click a package code to view its specific billing and regulatory data.

52412-300-20
5 VIAL, SINGLE-USE in 1 BLISTER PACK / .5 mL in 1 VIAL, SINGLE-USE

* 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 52412-300-10 identifies a specific commercial package of 1 bottle, with applicator in 1 carton / 50 ml in 1 bottle, with applicator of Fire Out, a human over the counter drug labeled by Randob Ltd.. This solution is formulated for topical use and contains benzocaine; menthol, unspecified form 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 Randob Ltd. on February 15, 2016. The current certification is valid through December 31, 2026.

How is this Randob Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52412030010. 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)
52412-300-10
11-Digit CMS (5-4-2)
52412-0300-10

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