Cold And Flu Severe Daytime/nighttime
NDC Package 36800-746-12

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.

Cold And Flu Severe Daytime/nighttime is take only as directeddo not exceed 8 softgels per 24 hrsadults & children 12 yrs and over2 softgels with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use take only as directeddo not exceed 8 softgels per 24 hoursadults & children 12 yrs and over2 softgels with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use. Marketed by Topco Associates Llc, this product is identified by NDC 36800-746 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
36800-746-12
Package Description
2 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
36800-746
11-Digit Billing Format
36800074612
RxNorm Crosswalk
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1297288 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
  • RxCUI: 1656815 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1656815 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Cold And Flu Severe Daytime/nighttime
Dosage Form
-
Usage Information
Take only as directeddo not exceed 8 softgels per 24 hrsadults & children 12 yrs and over2 softgels with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use take only as directeddo not exceed 8 softgels per 24 hoursadults & children 12 yrs and over2 softgels with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo 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
05-01-2021
Listing Expiration
12-31-2022
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 36800-746-12 identifies a specific commercial package of 2 blister pack in 1 carton / 1 kit in 1 blister pack of Cold And Flu Severe Daytime/nighttime, 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 May 01, 2021. The current certification is valid through December 31, 2022.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800074612. 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)
36800-746-12
11-Digit CMS (5-4-2)
36800-0746-12

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