Daytime Cold And Flu Severe And Nighttime Cold And Flu Severe
NDC Package 36800-412-04

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.

Daytime Cold And Flu Severe And Nighttime Cold And Flu Severe is take only as directed - see Overdose warningdo not exceed 4 doses per 24 hrsDosing for Daytimeadults & children 12 yrs & over     2 softgels with water every 4 hrschildren 4 to under 12 yrs     ask a doctorchildren under 4 yrs     do not useDosing for Nighttime adults & children 12 yrs & over     2 softgels with water every 4 hrschildren 4 to under 12 yrs     ask a doctorchildren under 4 yrs     do not usewhen using other Nighttime or Daytime products, carefully read each label to ensure correct dosing. Marketed by Topco Associates Llc, this product is identified by NDC 36800-412 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
36800-412-04
Package Description
1 KIT in 1 CARTON * 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
36800-412
11-Digit Billing Format
36800041204
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
Daytime Cold And Flu Severe And Nighttime Cold And Flu Severe
Dosage Form
-
Usage Information
Take only as directed - see Overdose warningdo not exceed 4 doses per 24 hrsDosing for Daytimeadults & children 12 yrs & over     2 softgels with water every 4 hrschildren 4 to under 12 yrs     ask a doctorchildren under 4 yrs     do not useDosing for Nighttime adults & children 12 yrs & over     2 softgels with water every 4 hrschildren 4 to under 12 yrs     ask a doctorchildren under 4 yrs     do not usewhen using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

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
06-28-2016
Listing Expiration
12-31-2024
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 36800-412-04 identifies a specific commercial package of 1 kit in 1 carton * 1 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack * 1 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack of Daytime Cold And Flu Severe And Nighttime Cold And Flu Severe, 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 June 28, 2016. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800041204. 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)
36800-412-04
11-Digit CMS (5-4-2)
36800-0412-04

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