NDC 69365-001 Facol Cold And Flu Day

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
69365-001
Proprietary Name:
Facol Cold And Flu Day
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Jw Holdings
Labeler Code:
69365
Start Marketing Date: [9]
08-01-2015
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
CAPSULE (C48336)
Size(s):
20 MM
Imprint(s):
FACD
Score:
1

Product Packages

NDC Code 69365-001-01

Package Description: 1 BLISTER PACK in 1 KIT / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Product Details

What is NDC 69365-001?

The NDC code 69365-001 is assigned by the FDA to the product Facol Cold And Flu Day which is product labeled by Jw Holdings. The product's dosage form is . The product is distributed in a single package with assigned NDC code 69365-001-01 1 blister pack in 1 kit / 1 capsule, liquid filled in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Facol Cold And Flu Day?

■ 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.

Which are Facol Cold And Flu Day UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Facol Cold And Flu Day Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Facol Cold And Flu Day?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Patient Education

Dextromethorphan


Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
[Learn More]


Guaifenesin


Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
[Learn More]


Phenylephrine


Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".