Childrens Cold Cough And Sore Throat Mixed Berry Liquid
NDC Package 76281-519-24

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

Package Information

Childrens Cold Cough And Sore Throat Mixed Berry (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl) liquids is uses• temporarily relieves these common cold and flu symptoms:• nasal congestion • stuffy nose • minor aches and pains • sore throat • headache • fever• cough due to minor throat and bronchial irritation• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tube. This formulation utilizes a liquid delivery system. Marketed by Aptapharma Inc., this product is identified by NDC 76281-519 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
76281-519-24
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
76281-519
11-Digit Billing Format
76281051924
RxNorm Crosswalk
  • RxCUI: 1593450 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Suspension
  • RxCUI: 1593450 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Suspension
  • RxCUI: 1593450 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Suspension
  • RxCUI: 1593450 - acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Suspension
  • RxCUI: 1593450 - APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Suspension

Clinical Specifications

Proprietary Name
Childrens Cold Cough And Sore Throat Mixed Berry
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
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
Uses• temporarily relieves these common cold and flu symptoms:• nasal congestion • stuffy nose • minor aches and pains • sore throat • headache • fever• cough due to minor throat and bronchial irritation• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tube

Regulatory & Marketing

Labeler Name
Aptapharma Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-30-2024
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 76281-519-24 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Childrens Cold Cough And Sore Throat Mixed Berry, a human over the counter drug labeled by Aptapharma Inc.. This liquid is formulated for oral use and contains acetaminophen; 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 Aptapharma Inc. on January 30, 2024. The current certification is valid through December 31, 2026.

How is this Aptapharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76281051924. 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)
76281-519-24
11-Digit CMS (5-4-2)
76281-0519-24

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