50580-414 NDC - TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE)

Drug Information

Product NDC: 50580-414

Proprietary Name: TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT

Non Proprietary Name: acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Active Ingredient(s):


Administration Route(s):

Dosage Form(s): KIT

Labeler Information

Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Product Type: HUMAN OTC DRUG
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:7/18/2016

Package Information

No. Package Code Package Description Billing Unit
150580-414-033 CARTON in 1 CELLO PACK (50580-414-03) / 1 KIT in 1 CARTON (50580-414-01) * 4 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK
250580-414-041 KIT in 1 CARTON (50580-414-04) * 4 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC50580-414The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMETYLENOL COLD PLUS FLU SEVERE DAY/NIGHTThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEacetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEKITThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE7/18/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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.
APPLICATION NUMBERpart341This 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.
LABELER NAMEJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionName of Company corresponding to the labeler code segment of the Product NDC.

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 2/1/2023