Topcare Nighttime Severe Cold And Cough
NDC Package 36800-800-06

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 Nighttime Severe Cold And Cough is when using this product- do not exceed recommended dosage- avoid alcoholic drinks- marked drowsiness may occur- alcohol, sedatives and tranquilizers may increase drowsiness- be careful when driving a motor vehicle or operating machinery- excitability may occur, especially in children. Marketed by Top Care (topco Associates Llc), this product is identified by NDC 36800-800 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
36800-800-06
Package Description
6 GRANULE, FOR SOLUTION in 1 BOX
Product Code
36800-800
11-Digit Billing Format
36800080006
RxNorm Crosswalk
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution
  • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
  • RxCUI: 1659960 - APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution

Clinical Specifications

Proprietary Name
Topcare Nighttime Severe Cold And Cough Honey Lemon Infused With Chamomile And White Tea Flavors
Dosage Form
-
Usage Information
When using this product- do not exceed recommended dosage- avoid alcoholic drinks- marked drowsiness may occur- alcohol, sedatives and tranquilizers may increase drowsiness- be careful when driving a motor vehicle or operating machinery- excitability may occur, especially in children.

Regulatory & Marketing

Labeler Name
Top Care (topco Associates Llc)
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-18-2014
Listing Expiration
12-31-2019
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 36800-800-06 identifies a specific commercial package of 6 granule, for solution in 1 box of Topcare Nighttime Severe Cold And Cough Honey Lemon Infused With Chamomile And White Tea Flavors, labeled by Top Care (topco Associates Llc). 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 Top Care (topco Associates Llc) on March 18, 2014. The current certification is valid through December 31, 2019.

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: 36800080006. 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)
36800-800-06
11-Digit CMS (5-4-2)
36800-0800-06

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