Cough And Runny Nose Suspension
NDC Package 36800-297-04

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

Package Information

Cough And Runny Nose (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide) suspension is this product does not contain directions or complete warnings for adult use.mL = milliliter shake well before using do not give more than 5 doses in any 24-hour period measure only with dosing cup provided. This formulation utilizes a suspension delivery system. Marketed by Top Care (topco Associates Llc), this product is identified by NDC 36800-297 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
36800-297-04
Package Description
1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC
Product Code
36800-297
11-Digit Billing Format
36800029704
RxNorm Crosswalk
  • RxCUI: 1086750 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension
  • RxCUI: 1086750 - acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension
  • RxCUI: 1086750 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension
  • RxCUI: 1086750 - APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension

Clinical Specifications

Proprietary Name
Cough And Runny Nose Childrens Plus
Non-Proprietary Name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide
Substance Name
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product does not contain directions or complete warnings for adult use.mL = milliliter shake well before using do not give more than 5 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose; otherwise, use ageWeight (lb)Age (yr)Dose (mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4do not use

Regulatory & Marketing

Labeler Name
Top Care (topco Associates Llc)
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-31-2015
End Marketing Date
06-01-2027
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 36800-297-04 identifies a specific commercial package of 1 bottle, plastic in 1 box / 118 ml in 1 bottle, plastic of Cough And Runny Nose Childrens Plus, a human over the counter drug labeled by Top Care (topco Associates Llc). This suspension is formulated for oral use and contains acetaminophen; chlorpheniramine maleate; dextromethorphan hydrobromide 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 Top Care (topco Associates Llc) on December 31, 2015.

How is this Top Care (topco Associates Llc) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800029704. 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)
36800-297-04
11-Digit CMS (5-4-2)
36800-0297-04

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