Broncochem Granule, For Solution
NDC Package 65131-097-53

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

Broncochem (acetaminophen-phenylephrine hydrochloride-chlorpheniramine maleate) granules is temporarily relieves these symptoms due to a cold:Minor aches and pains.Minor sore throat pain.Headache.Nasal and sinus congestion.Runny nose.SneezingItchy nose or throat.Itchy, watery eyes due to hay fever.Cough due to minor throat and bronchial irritation.Temporarily reduces fever. This formulation utilizes a granule, for solution delivery system. Marketed by Laboratorio Magnachem International Srl, this product is identified by NDC 65131-097 and is authorized under FDA application M.

Identification & Billing

NDC Package Code
65131-097-53
Package Description
6 PACKAGE in 1 BOX / 13 g in 1 PACKAGE (65131-097-52)
Product Code
65131-097
11-Digit Billing Format
65131009753

Clinical Specifications

Proprietary Name
Broncochem Cold And Flu Tea
Non-Proprietary Name
Acetaminophen-phenylephrine Hydrochloride-chlorpheniramine Maleate
Substance Name
Acetaminophen; Chlorpheniramine Maleate
Dosage Form
Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Temporarily relieves these symptoms due to a cold:Minor aches and pains.Minor sore throat pain.Headache.Nasal and sinus congestion.Runny nose.SneezingItchy nose or throat.Itchy, watery eyes due to hay fever.Cough due to minor throat and bronchial irritation.Temporarily reduces fever.

Regulatory & Marketing

Labeler Name
Laboratorio Magnachem International Srl
Product Type
Human Otc Drug
FDA Application #
M
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-01-2013
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 (65131-097). Click a package code to view its specific billing and regulatory data.

65131-097-12
25 PACKAGE in 1 BOX / 13 g in 1 PACKAGE (65131-097-52)

* 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 65131-097-53 identifies a specific commercial package of 6 package in 1 box / 13 g in 1 package (65131-097-52) of Broncochem Cold And Flu Tea, a human over the counter drug labeled by Laboratorio Magnachem International Srl. This granule, for solution is formulated for oral use and contains acetaminophen; chlorpheniramine maleate 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 Laboratorio Magnachem International Srl on September 01, 2013. The current certification is valid through December 31, 2026.

How is this Laboratorio Magnachem International Srl product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65131009753. 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)
65131-097-53
11-Digit CMS (5-4-2)
65131-0097-53

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