0031-8729 NDC - DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Drug Information

  • Product NDC: 0031-8729
  • Proprietary Name:
  • Non Proprietary Name: Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
  • Active Ingredient(s): 10 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE; 100 mg/5mL GUAIFENESIN; 5 mg/5mL PHENYLEPHRINE HYDROCHLORIDE
  • Administration Route(s):
  • Dosage Form(s): SYRUP

Labeler Information

Field Name Field Value
Labeler Name: Haleon US Holdings LLC
Product Type: BULK INGREDIENT
FDA Application Number:
Marketing Category: EXPORT ONLY
Start Marketing Date:9/1/2015

Package Information

No. Package Code Package Description Billing Unit
10031-8729-0175708 mL in 1 CONTAINER (0031-8729-01)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0031-8729The 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 NAMEBULK INGREDIENTIndicates 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.
NON PROPRIETARY NAMEDextromethorphan Hydrobromide, Guaifenesin, 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 NAMESYRUPThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE9/1/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEEXPORT ONLYProduct 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.
LABELER NAMEHaleon US Holdings LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDEXTROMETHORPHAN 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 STRENGTH10; 100; 5 
ACTIVE INGRED UNITmg/5mL; mg/5mL; mg/5mL 

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: 5/24/2024