NDC 0031-8754 Robitussin 12 Hour Cough Relief
Dextromethorphan Polistirex Suspension, Extended Release Oral

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0031-8754?
    5. Robitussin 12 Hour Cough Relief Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. NDC to RxNorm Crosswalk
    10. Pharmacologic Classes
    11. Patient Education

Product Information

NDC Product Code0031-8754
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Robitussin 12 Hour Cough Relief
Non-Proprietary Name 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.		Dextromethorphan Polistirex
Substance Name 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.		Dextromethorphan Hydrobromide
Product Type 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.		Human Otc Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormSuspension, Extended Release - A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0031
SPL SET ID:5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5
FDA Application Number What is the FDA Application Number?
This 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.		ANDA091135
Marketing Category 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.		ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		07-05-2016
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

Product Characteristics

Color(s)ORANGE (C48331)
Flavor(s)ORANGE (C73406)

Product Packages

NDC Code 0031-8754-15

Package Description: 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE

Product Details

What is NDC 0031-8754?

The NDC code 0031-8754 is assigned by the FDA to the product Robitussin 12 Hour Cough Relief which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Robitussin 12 Hour Cough Relief is dextromethorphan polistirex. The product's dosage form is suspension, extended release and is administered via oral form. The product is distributed in a single package with assigned NDC code 0031-8754-15 1 bottle in 1 carton / 148 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Robitussin 12 Hour Cough Relief?

This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This product should not usually be used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor. This product contains dextromethorphan. It is a cough suppressant that works by decreasing the feeling of needing to cough. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

What are Robitussin 12 Hour Cough Relief Active Ingredients?

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 30 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.

Which are Robitussin 12 Hour Cough Relief UNII Codes?

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

  • DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
  • DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)

Which are Robitussin 12 Hour Cough Relief Inactive Ingredients 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:

What is the NDC to RxNorm Crosswalk for Robitussin 12 Hour Cough Relief?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1373045 - dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension
  • RxCUI: 1373045 - 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension

Which are the Pharmacologic Classes for Robitussin 12 Hour Cough Relief?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Dextromethorphan


Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
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Product Label

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