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  4. NDC Product Code: 0031-9311 Robitussin Nighttime Cough Dm Soft Chews

NDC 0031-9311 Robitussin Nighttime Cough Dm Soft Chews

Dextromethorphan Hydrobromide,Doxylamine Succinate Tablet, Chewable Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0031-9311?
  5. Robitussin Nighttime Cough Dm Soft Chews Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

NDC Product Code:
0031-9311
Proprietary Name:
Robitussin Nighttime Cough Dm Soft Chews
Non-Proprietary Name: [1]
Dextromethorphan Hydrobromide, Doxylamine Succinate
Substance Name: [2]
Dextromethorphan Hydrobromide; Doxylamine Succinate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Haleon Us Holdings Llc
    Labeler Code:
    0031
    Product Label ID:
    39468746-e06d-4849-9d06-9af4d14351b0
    FDA Application Number: [6]
    M012
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    06-19-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    PURPLE (C48327 - DARKER PURPLE SPECKLES)
    Shape:
    ROUND (C48348)
    Size(s):
    21 MM
    Imprint(s):
    R
    Score:
    1
    Flavor(s):
    BERRY (C73365)

    Code Structure Chart

    Product Details

    What is NDC 0031-9311?

    The NDC code 0031-9311 is assigned by the FDA to the product Robitussin Nighttime Cough Dm Soft Chews which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Robitussin Nighttime Cough Dm Soft Chews is dextromethorphan hydrobromide, doxylamine succinate. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 0031-9311-20 20 tablet, chewable 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 Nighttime Cough Dm Soft Chews?

    Usestemporarily relieves cough due to minor throat and bronchial irritation as may occur with a coldtemporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nosesneezingitchywatery eyesitching of the nose or throatcontrols the impulse to cough to help you sleep

    What are Robitussin Nighttime Cough Dm Soft Chews 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 15 mg/1 - 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.
    • DOXYLAMINE SUCCINATE 6.25 mg/1

    Which are Robitussin Nighttime Cough Dm Soft Chews UNII Codes?

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

    Which are Robitussin Nighttime Cough Dm Soft Chews 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:

    Which are the Pharmacologic Classes for Robitussin Nighttime Cough Dm Soft Chews?

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".