Giltuss D Syrup
NDC Package 65852-010-04

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

Package Information

Giltuss D syrups is directions, not take more than 6 doses in any 24 hours period, use enclosed dosing cup, keep dosage cup for use with this product, ml= mililiterAdults and children 12 years and over 10 ml every 4 hoursChildren 6 to under 12 years 5 ml every 4 hoursChildren under 6 years Consult a doctor. This formulation utilizes a syrup delivery system. Marketed by Dextrum Laboratories Inc., this product is identified by NDC 65852-010 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
65852-010-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
65852-010
11-Digit Billing Format
65852001004
RxNorm Crosswalk
  • RxCUI: 2724415 - chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG in 10 mL Oral Solution
  • RxCUI: 2724415 - chlorpheniramine maleate 0.35 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 2724415 - chlorpheniramine maleate 1.75 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral Solution
  • RxCUI: 2724415 - chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG per 10 ML Oral Solution

Clinical Specifications

Proprietary Name
Giltuss D
Non-Proprietary Name
Giltuss D
Substance Name
Chlorpheniramine Maleate; Phenylephrine Hydrochloride
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Directions, not take more than 6 doses in any 24 hours period, use enclosed dosing cup, keep dosage cup for use with this product, ml= mililiterAdults and children 12 years and over 10 ml every 4 hoursChildren 6 to under 12 years 5 ml every 4 hoursChildren under 6 years Consult a doctor

Regulatory & Marketing

Labeler Name
Dextrum Laboratories Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-11-2024
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 65852-010-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Giltuss D, a human over the counter drug labeled by Dextrum Laboratories Inc.. This syrup is formulated for oral use and contains chlorpheniramine maleate; 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 April 11, 2024. 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: 65852001004. 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)
65852-010-04
11-Digit CMS (5-4-2)
65852-0010-04

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