Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride Syrup
NDC 0031-8729

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0031-8729?
  4. Active Ingredients
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride is a EXPORT ONLY-approved product labeled by Haleon Us Holdings Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a syrup. This product entry covers the primary NDC 0031-8729 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0031-8729
Proprietary Name:
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Non-Proprietary Name: [1]
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Substance Name: [2]
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.

Labeler & Regulatory Data

Labeler Name: [5]
Haleon Us Holdings Llc
Labeler Code:
0031
Product Label ID:
5734b4da-d1eb-4cb5-afa2-eeeebcdd2b08
Marketing Category: [8]
EXPORT ONLY - A product that is only exported and not marketed in the United States.

Marketing Timeline

Start Marketing Date: [9]
09-01-2015
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes

Code Structure Chart

Product Details

What is NDC 0031-8729?

The NDC code 0031-8729 is assigned by the FDA to the product Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride. It is commonly known by its generic name, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride. This pharmaceutical product is labeled by Haleon Us Holdings Llc and is currently categorized as listed product. The medication is a syrup. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0031-8729-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are Active Ingredients of this product?

An 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.
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
  • GUAIFENESIN 100 mg/5mL - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An 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.
What kind of product is this? Indicates 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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
What is an Unfinished Product? This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.