Facol Cold And Flu Day
NDC Package 69365-001-01

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.

Facol Cold And Flu Day is ■ Do not take more than directed (see overdose warning) ■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day ■ swallow whole-do not crush, chew or dissolve ■ do not take night time capsule in less than 6 hours after taking day time capsule ■ children under 15 years: do not use and ask a doctor. Marketed by Jw Holdings, this product is identified by NDC 69365-001 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
69365-001-01
Package Description
1 BLISTER PACK in 1 KIT / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
69365-001
11-Digit Billing Format
69365000101
RxNorm Crosswalk
  • RxCUI: 1664451 - acetaminophen 200 MG / dextromethorphan HBr 8 MG / guaiFENesin 35 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1664451 - acetaminophen 200 MG / dextromethorphan hydrobromide 8 MG / guaifenesin 35 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1664451 - APAP 200 MG / Dextromethorphan Hydrobromide 8 MG / Guaifenesin 35 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Facol Cold And Flu Day
Dosage Form
-
Usage Information
■ Do not take more than directed (see overdose warning) ■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day ■ swallow whole-do not crush, chew or dissolve ■ do not take night time capsule in less than 6 hours after taking day time capsule ■ children under 15 years: do not use and ask a doctor.

Regulatory & Marketing

Labeler Name
Jw Holdings
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-01-2015
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 69365-001-01 identifies a specific commercial package of 1 blister pack in 1 kit / 1 capsule, liquid filled in 1 blister pack of Facol Cold And Flu Day, labeled by Jw Holdings. 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 Jw Holdings on August 01, 2015. The current certification is valid through December 31, 2025.

How is this Jw Holdings product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69365000101. 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)
69365-001-01
11-Digit CMS (5-4-2)
69365-0001-01

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