Topco Liquid
NDC Package 76162-751-04

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

Package Information

Topco (dextromethorphan hbr and guaifenesin) liquids is ▪do not give more than 6 doses in any 24-hour period▪measure only with dosing cup provided▪do not use dosing cup with other products▪dose as follows or as directed by a doctorAgeDosechildren 6 years to under 12 years of age5 mL – 10 mL every 4 hourschildren 4 years to under 6 years of age2.5 mL – 5 mL every 4 hourschildren under 4 yearsdo not use. This formulation utilizes a liquid delivery system. Marketed by Topco Associates, Llc, this product is identified by NDC 76162-751 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
76162-751-04
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
76162-751
11-Digit Billing Format
76162075104
RxNorm Crosswalk
  • RxCUI: 1020138 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution
  • RxCUI: 1020138 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 1020138 - dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution
  • RxCUI: 1020138 - dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Topco Childrens Cough Relief
Non-Proprietary Name
Dextromethorphan Hbr And Guaifenesin
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
▪do not give more than 6 doses in any 24-hour period▪measure only with dosing cup provided▪do not use dosing cup with other products▪dose as follows or as directed by a doctorAgeDosechildren 6 years to under 12 years of age5 mL – 10 mL every 4 hourschildren 4 years to under 6 years of age2.5 mL – 5 mL every 4 hourschildren under 4 yearsdo not use

Regulatory & Marketing

Labeler Name
Topco Associates, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-21-2024
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 76162-751-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Topco Childrens Cough Relief, a human over the counter drug labeled by Topco Associates, Llc. This liquid is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin 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 Topco Associates, Llc on October 21, 2024. The current certification is valid through December 31, 2026.

How is this Topco Associates, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162075104. 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)
76162-751-04
11-Digit CMS (5-4-2)
76162-0751-04

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