Daytime Severe Cold And Flu Relief Softgels
NDC Package 36800-655-24

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 Severe Cold And Flu Relief Softgels is ■ take only as directed ■ do not exceed 8 softgels per 24 hours   adults & children 12 years & over  2 softgels with water every 4 hours  children 4 to under 12 years ask a doctor children under 4 years do not use ■ when 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 36800-655 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
36800-655-24
Package Description
2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
36800-655
11-Digit Billing Format
36800065524
RxNorm Crosswalk
  • 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
  • RxCUI: 1656815 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Daytime Severe Cold And Flu Relief Softgels
Dosage Form
-
Usage Information
■ take only as directed ■ do not exceed 8 softgels per 24 hours   adults & children 12 years & over  2 softgels with water every 4 hours  children 4 to under 12 years ask a doctor children under 4 years do not use ■ when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Regulatory & Marketing

Labeler Name
Topco Associates Llc
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-31-2019
Listing Expiration
12-31-2025
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 36800-655-24 identifies a specific commercial package of 2 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack of Daytime Severe Cold And Flu Relief Softgels, 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 October 31, 2019. The current certification is valid through December 31, 2025.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800065524. 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)
36800-655-24
11-Digit CMS (5-4-2)
36800-0655-24

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