51013-189 NDC - DAY TIME COLD FLU MEDICINE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE)

Drug Information

Product NDC: 51013-189

Proprietary Name: DAY TIME Cold Flu Medicine

Non Proprietary Name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Active Ingredient(s):
  • 325 mg/1 ACETAMINOPHEN;
  • 10 mg/1 DEXTROMETHORPHAN HYDROBROMIDE;
  • 5 mg/1 PHENYLEPHRINE HYDROCHLORIDE


Administration Route(s): ORAL

Dosage Form(s): CAPSULE, LIQUID FILLED

Pharmacy Class(es):
  • Adrenergic alpha1-Agonists [MoA];
  • 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: PuraCap Pharmaceutical LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:10/6/2016

Package Information

No. Package Code Package Description Billing Unit
151013-189-082 BLISTER PACK in 1 CARTON (51013-189-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC51013-189The 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 NAMEDAY TIME Cold Flu MedicineThe 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, 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 NAMECAPSULE, LIQUID FILLEDThe 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 DATE10/6/2016This 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 NAMEPuraCap Pharmaceutical LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; 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 STRENGTH325; 10; 5 
ACTIVE INGRED UNITmg/1; mg/1; mg/1 
PHARM CLASSESAdrenergic alpha1-Agonists [MoA], 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