Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief
NDC Package 36800-562-08

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief is daytime•take only as directed - see Overdose warning•do not exceed 4 doses per 24 hoursadults & children 12yrs & overone cup every 4 hrschildren under 12yrsdo not use•place single–serve cup in compatible brewer•use a minimum of 8 oz of water •when finished, the single serve cups are hot and may drip. Marketed by Topcare Health, this product is identified by NDC 36800-562 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
36800-562-08
Package Description
1 KIT in 1 KIT * 4 CUP in 1 KIT / 1 POWDER, FOR SOLUTION in 1 CUP * 4 CUP in 1 KIT / 1 POWDER, FOR SOLUTION in 1 CUP
Product Code
36800-562
11-Digit Billing Format
36800056208
RxNorm Crosswalk
  • RxCUI: 1659967 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution
  • RxCUI: 1659967 - acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
  • RxCUI: 1659967 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution
  • RxCUI: 1659967 - APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution
  • RxCUI: 1805288 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack
Dosage Form
-
Usage Information
Daytime•take only as directed - see Overdose warning•do not exceed 4 doses per 24 hoursadults & children 12yrs & overone cup every 4 hrschildren under 12yrsdo not use•place single–serve cup in compatible brewer•use a minimum of 8 oz of water •when finished, the single serve cups are hot and may drip. Tilt the cup during removal to avoid dripping.•DO NOT REMOVE THE FOIL SEAL as the cup will not work properly in any single serve compatible brewer and could result in hot water burns.•Flush brewer after use Nighttime•take only as directed - see Overdose warning•do not exceed 4 doses per 24 hoursadults & children 12yrs & overone cup every 6 hrschildren under 12yrsdo not use•place single-serve cup in any compatible brewer†•use a minimum of 8 oz of water•when finished, the single serve cups are hot and may drip. Tilt the cup during removal to avoid dripping.•DO NOT REMOVE THE FOIL SEAL as the cup will not work properly in any single serve compatible brewer and could result in hot water burns.•Flush brewer after use

Regulatory & Marketing

Labeler Name
Topcare Health
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-06-2019
Listing Expiration
12-31-2023
Exclude Flag
I
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 36800-562-08 identifies a specific commercial package of 1 kit in 1 kit * 4 cup in 1 kit / 1 powder, for solution in 1 cup * 4 cup in 1 kit / 1 powder, for solution in 1 cup of Topcare Health Non Drowsy Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief Day And Night Combo Pack, labeled by Topcare Health. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Topcare Health on March 06, 2019. The current certification is valid through December 31, 2023.

How is this Topcare Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800056208. 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)
36800-562-08
11-Digit CMS (5-4-2)
36800-0562-08

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