Drug Information

Product NDC: 50580-507

Proprietary Name: Tylenol Sinus Severe

Non Proprietary Name: Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride

Active Ingredient(s):
  • 325 mg/1 ACETAMINOPHEN;
  • 200 mg/1 GUAIFENESIN;

Administration Route(s): ORAL

Dosage Form(s): TABLET, COATED

Pharmacy Class(es):
  • Adrenergic alpha1-Agonists [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:5/15/2015

Package Information

No. Package Code Package Description Billing Unit
150580-507-012 BLISTER PACK in 1 CARTON (50580-507-01) > 12 TABLET, COATED in 1 BLISTER PACKEA
250580-507-032 TABLET, COATED in 1 POUCH (50580-507-03)
350580-507-0450 POUCH in 1 CARTON (50580-507-04) > 2 TABLET, COATED in 1 POUCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC50580-507The 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 Sinus 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, 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 NAMETABLET, COATEDThe 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 DATE5/15/2015This 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; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE INGRED UNITmg/1; mg/1; mg/1 
PHARM CLASSESAdrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] 

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This page was last updated on: 2/14/2022