Search Icon

0485-0080 NDC - RYMED (DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE)

Drug Information

Product NDC: 0485-0080

Proprietary Name: RYMED

Non Proprietary Name: DEXCHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE

Active Ingredient(s):
  • 2 mg/1 DEXCHLORPHENIRAMINE MALEATE;
  • 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE


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: EDWARDS PHARMACEUTICALS, INC.
Product Type: HUMAN OTC DRUG
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:11/15/2011

Package Information

No. Package Code Package Description Billing Unit
10485-0080-01100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0080-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0485-0080The 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 NAMERYMEDThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEDEXCHLORPHENIRAMINE MALEATE 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 DATE11/15/2011This 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 NAMEEDWARDS PHARMACEUTICALS, INC.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDEXCHLORPHENIRAMINE MALEATE; 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 STRENGTH2; 10 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESAdrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] 

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: 11/4/2022