71335-1928 NDC - MUCUS RELIEF COUGH AND CONGESTION DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR)

Drug Information

  • Product NDC: 71335-1928
  • Proprietary Name: Mucus Relief Cough and Congestion DM
  • Non Proprietary Name: Guaifenesin and Dextromethorphan HBr
  • Active Ingredient(s): 20 mg/1 DEXTROMETHORPHAN HYDROBROMIDE; 400 mg/1 GUAIFENESIN
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): 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]

Labeler Information

Field Name Field Value
Labeler Name: Bryant Ranch Prepack
Product Type: HUMAN OTC DRUG
FDA Application Number: M012
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:4/1/2016

Package Information

No. Package Code Package Description Billing Unit
171335-1928-130 TABLET in 1 BOTTLE (71335-1928-1)
271335-1928-220 TABLET in 1 BOTTLE (71335-1928-2)
371335-1928-318 TABLET in 1 BOTTLE (71335-1928-3)

NDC Record

Field Name Field Value Definition
PRODUCT NDC71335-1928The 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 NAMEMucus Relief Cough and Congestion DMThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
NON PROPRIETARY NAMEGuaifenesin and Dextromethorphan HBrThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe 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 DATE4/1/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGThe 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.
APPLICATION NUMBERM012The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
LABELER NAMEBryant Ranch PrepackThis is the date that the labeler indicates was the start of its marketing of the drug product.
SUBSTANCE NAMEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINProduct 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.
ACTIVE NUMERATOR STRENGTH20; 400 
ACTIVE INGRED UNITmg/1; mg/1The 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.
PHARM CLASSESDecreased 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] 

Download Record

Download this NDC record record in Text format: Export

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

Download this NDC record record in XML format: Export

This page was last updated on: 11/21/2025

Previous Code
Next Code