50580-403 NDC - TYLENOL COLD PLUS FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE)

Drug Information

Product NDC: 50580-403

Proprietary Name: TYLENOL COLD PLUS FLU SEVERE

Non Proprietary Name: Acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Active Ingredient(s):
  • 650 mg/30mL ACETAMINOPHEN;
  • 20 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE;
  • 400 mg/30mL GUAIFENESIN;
  • 10 mg/30mL PHENYLEPHRINE HYDROCHLORIDE


Administration Route(s): ORAL

Dosage Form(s): SOLUTION

Pharmacy Class(es):
  • Adrenergic alpha1-Agonists [MoA];
  • Decreased Respiratory Secretion Viscosity [PE];
  • Expectorant [EPC];
  • Increased Respiratory Secretions [PE];
  • Sigma-1 Agonist [EPC];
  • Sigma-1 Receptor Agonists [MoA];
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC];
  • Uncompetitive NMDA Receptor Antagonists [MoA];
  • alpha-1 Adrenergic Agonist [EPC]

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:7/5/2010

Package Information

No. Package Code Package Description Billing Unit
150580-403-08240 mL in 1 BOTTLE, PLASTIC (50580-403-08)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC50580-403The 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 SEVEREThe 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, 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 NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/5/2010This 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.
SUBSTANCE NAMEACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH650; 20; 400; 10 
ACTIVE INGRED UNITmg/30mL; mg/30mL; mg/30mL; mg/30mL 
PHARM CLASSESAdrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] 

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