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NDC 73581-404 Mucus Relief - Dm Maximum Strength

Guaifenesin,Dextromethorphan Hbr Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 73581-404?
  5. Mucus Relief - Dm Maximum Strength 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:
73581-404
Proprietary Name:
Mucus Relief - Dm Maximum Strength
Non-Proprietary Name: [1]
Guaifenesin, Dextromethorphan Hbr
Substance Name: [2]
Dextromethorphan Hydrobromide; Guaifenesin
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Yyba Corp
    Labeler Code:
    73581
    Product Label ID:
    fc8c9341-6d6f-d194-e053-6294a90ac891
    FDA Application Number: [6]
    ANDA206941
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    05-25-2023
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF-WHITE)
    Shape:
    OVAL (C48345)
    Size(s):
    23 MM
    Imprint(s):
    X;63
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 73581-404?

    The NDC code 73581-404 is assigned by the FDA to the product Mucus Relief - Dm Maximum Strength which is a human over the counter drug product labeled by Yyba Corp. The generic name of Mucus Relief - Dm Maximum Strength is guaifenesin, dextromethorphan hbr. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 73581-404-05 50 tablet 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 Mucus Relief - Dm Maximum Strength?

    Do not crush, chew, or break tablettake with a full glass of waterthis product can be administered without regard for timing of mealsadults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hourschildren under 12 years of age: do not use

    What are Mucus Relief - Dm Maximum Strength 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 60 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.
    • GUAIFENESIN 1200 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.

    Which are Mucus Relief - Dm Maximum Strength UNII Codes?

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

    Which are Mucus Relief - Dm Maximum Strength 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 Mucus Relief - Dm Maximum Strength?

    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: 1099074 - guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet
    • RxCUI: 1099074 - 12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet
    • RxCUI: 1099074 - dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet

    * 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".