Giltuss Childrens Multisymptom Cold And Flu Solution
NDC Package 58552-137-04

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

Package Information

Giltuss Childrens Multisymptom Cold And Flu (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride) solution is uses temporarily relieves:minor aches and painsheadacheminor sore throat painrunny noseitchy nose or throatsneezingitchy watery eyes due to hay fevernasal and sinus congestioncough due to minor throat and bronchial irritation as may occur with a coldtemporarily reduces fever. This formulation utilizes a solution delivery system. Marketed by Giltuss Pharmaceutical Corp, this product is identified by NDC 58552-137 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
58552-137-04
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
58552-137
11-Digit Billing Format
58552013704
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2121065 - acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 6.5 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution
  • RxCUI: 2121065 - acetaminophen 65 MG/ML / chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 1.3 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 2121065 - acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 6.5 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral Solution
  • RxCUI: 2121065 - APAP 65 MG/ML / Chlorpheniramine Maleate 0.4 MG/ML / Dextromethorphan Hydrobromide 1.3 MG/ML / Phenylephrine Hydrochloride 1 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Giltuss Childrens Multisymptom Cold And Flu
Non-Proprietary Name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Uses temporarily relieves:minor aches and painsheadacheminor sore throat painrunny noseitchy nose or throatsneezingitchy watery eyes due to hay fevernasal and sinus congestioncough due to minor throat and bronchial irritation as may occur with a coldtemporarily reduces fever

Regulatory & Marketing

Labeler Name
Giltuss Pharmaceutical Corp
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-02-2018
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 58552-137-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Giltuss Childrens Multisymptom Cold And Flu, a human over the counter drug labeled by Giltuss Pharmaceutical Corp. This solution is formulated for oral use and contains acetaminophen; chlorpheniramine maleate; dextromethorphan hydrobromide; phenylephrine hydrochloride 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 Giltuss Pharmaceutical Corp on October 02, 2018. The current certification is valid through December 31, 2026.

How is this Giltuss Pharmaceutical Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58552013704. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
58552-137-04
11-Digit CMS (5-4-2)
58552-0137-04

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