NDC 50580-526 Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 2-pack

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Guaifenesin, Phenylephrine Hydrochloride

NDC Product Code 50580-526

NDC Code: 50580-526

Proprietary Name: Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 2-pack What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Guaifenesin, Phenylephrine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 50580 - Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
    • 50580-526 - Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 2-pack

NDC 50580-526-01

Package Description: 1 KIT in 1 PACKAGE * 240 mL in 1 BOTTLE (50580-369-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08)

NDC Product Information

Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 2-pack with NDC 50580-526 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The generic name of Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 2-pack is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride. The product's dosage form is kit and is administered via form.

Labeler Name: Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Product Labeler Information

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

Labeler Name: Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
Labeler Code: 50580
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-28-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 2-pack Product Label Images