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  4. NDC Product Code: 0031-9307 Robitussin Medi-soothers

NDC 0031-9307 Robitussin Medi-soothers

Dextromethorphan Hydrobromide,Menthol Lozenge Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0031-9307?
  5. Robitussin Medi-soothers Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
0031-9307
Proprietary Name:
Robitussin Medi-soothers
Non-Proprietary Name: [1]
Dextromethorphan Hydrobromide, Menthol
Substance Name: [2]
Dextromethorphan Hydrobromide; Menthol, Unspecified Form
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
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:
    4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5
    FDA Application Number: [6]
    M012
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    06-01-2023
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    PURPLE (C48327)
    Shape:
    OVAL (C48345)
    Size(s):
    25 MM
    Imprint(s):
    R
    Score:
    1
    Flavor(s):
    BERRY (C73365 - ELDERBERRY)

    Code Structure Chart

    Product Details

    What is NDC 0031-9307?

    The NDC code 0031-9307 is assigned by the FDA to the product Robitussin Medi-soothers which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Robitussin Medi-soothers is dextromethorphan hydrobromide, menthol. The product's dosage form is lozenge and is administered via oral form. The product is distributed in a single package with assigned NDC code 0031-9307-01 16 lozenge in 1 blister pack . 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 Medi-soothers?

    ▪adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) every 4 hours as needed. Allow each lozenge to dissolve slowly in the mouth.▪do not take more than 12 lozenges in any 24-hour period, or as directed by a doctor▪children under 12 years of age: do not use

    What are Robitussin Medi-soothers 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 5 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.
    • MENTHOL, UNSPECIFIED FORM 5 mg/1

    Which are Robitussin Medi-soothers UNII Codes?

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

    • DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
    • DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
    • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
    • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (Active Moiety)

    Which are Robitussin Medi-soothers 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 Medi-soothers?

    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: 1301246 - dextromethorphan HBr 5 MG / menthol 5 MG Oral Lozenge
    • RxCUI: 1301246 - dextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge

    Which are the Pharmacologic Classes for Robitussin Medi-soothers?

    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.

    * 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".