Topcare Nighttime Cold And Flu Simple Relief
NDC Package 36800-888-08

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 Nighttime Cold And Flu Simple Relief is do not exceed recommended dosage.do not take more than 6 doses in any 24-hour period.use enclosed dose cup keep dosage cup with productmL = milliliters adults and children 12 years of age and over: 30mL every 4 hourschildren under 12 years of age: do not use. Marketed by Topco Associates Llc, this product is identified by NDC 36800-888 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
36800-888-08
Package Description
237 mL in 1 BOTTLE
Product Code
36800-888
11-Digit Billing Format
36800088808

Clinical Specifications

Proprietary Name
Topcare Nighttime Cold And Flu Simple Relief
Dosage Form
-
Usage Information
Do not exceed recommended dosage.do not take more than 6 doses in any 24-hour period.use enclosed dose cup keep dosage cup with productmL = milliliters adults and children 12 years of age and over: 30mL every 4 hourschildren under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
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
09-06-2016
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 36800-888-08 identifies a specific commercial package of 237 ml in 1 bottle of Topcare Nighttime Cold And Flu Simple Relief, labeled by 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 Topco Associates Llc on September 06, 2016. The current certification is valid through December 31, 2019.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800088808. 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)
36800-888-08
11-Digit CMS (5-4-2)
36800-0888-08

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