Giltuss Childrens Cough And Cold Solution
NDC Package 65852-011-04

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

Package Information

Giltuss Childrens Cough And Cold (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) solution is directions* no take more than 6 doses in any 24 hours period * use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiterChildren under 4 years ----Consult a doctorchildren 4 to under 6 years------1.25 ml every 4 hourschildren 6 to under 12 years-----2.5 ml every 4 hourschildren 12 yeras and over -------5 ml every 4 hoursOther informationstore at room temperature 15 - 30 0c* close cap tightly* save carton for complete drug facts. This formulation utilizes a solution delivery system. Marketed by Dextrum Laboratories Inc., this product is identified by NDC 65852-011 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
65852-011-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
65852-011
11-Digit Billing Format
65852001104
RxNorm Crosswalk
  • RxCUI: 1251031 - dextromethorphan HBr 15 MG / guaiFENesin 300 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution
  • RxCUI: 1251031 - dextromethorphan hydrobromide 3 MG/ML / guaifenesin 60 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
  • RxCUI: 1251031 - dextromethorphan HBr 15 MG / guaifenesin 300 MG / phenylephrine HCl 10 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Giltuss Childrens Cough And Cold
Non-Proprietary Name
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin; 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
Directions* no take more than 6 doses in any 24 hours period * use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiterChildren under 4 years ----Consult a doctorchildren 4 to under 6 years------1.25 ml every 4 hourschildren 6 to under 12 years-----2.5 ml every 4 hourschildren 12 yeras and over -------5 ml every 4 hoursOther informationstore at room temperature 15 - 30 0c* close cap tightly* save carton for complete drug facts

Regulatory & Marketing

Labeler Name
Dextrum Laboratories Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-07-2018
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 65852-011-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Giltuss Childrens Cough And Cold, a human over the counter drug labeled by Dextrum Laboratories Inc.. This solution is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin; 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 Dextrum Laboratories Inc. on November 07, 2018. The current certification is valid through December 31, 2026.

How is this Dextrum Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65852001104. 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)
65852-011-04
11-Digit CMS (5-4-2)
65852-0011-04

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