NDC 11523-7158 Coricidin Hbp Chest Congestion And Cough

Dextromethorphan Hydrobromide And Guaifenesin Capsule, Gelatin Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
11523-7158
Proprietary Name:
Coricidin Hbp Chest Congestion And Cough
Non-Proprietary Name: [1]
Dextromethorphan Hydrobromide And Guaifenesin
Substance Name: [2]
Dextromethorphan Hydrobromide; Guaifenesin
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Bayer Healthcare Llc.
    Labeler Code:
    11523
    FDA Application Number: [6]
    part341
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    08-31-2000
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    RED (C48326)
    Shape:
    OVAL (C48345)
    Size(s):
    20 MM
    Imprint(s):
    C;HBP
    Score:
    1

    Product Details

    What is NDC 11523-7158?

    The NDC code 11523-7158 is assigned by the FDA to the product Coricidin Hbp Chest Congestion And Cough which is a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Coricidin Hbp Chest Congestion And Cough is dextromethorphan hydrobromide and guaifenesin. The product's dosage form is capsule, gelatin coated and is administered via oral form. 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 Coricidin Hbp Chest Congestion And Cough?

    Do not exceed recommended doseadults and children 12 years and over: 1 or 2 softgels every 4 hours, not more than 12 softgels in 24 hours children under 12 years of age: ask a doctor

    What are Coricidin Hbp Chest Congestion And Cough 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 10 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 200 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.

    Which are Coricidin Hbp Chest Congestion And Cough UNII Codes?

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

    Which are Coricidin Hbp Chest Congestion And Cough 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 Coricidin Hbp Chest Congestion And Cough?

    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: 1111663 - dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral Capsule
    • RxCUI: 1111663 - dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral Capsule

    Which are the Pharmacologic Classes for Coricidin Hbp Chest Congestion And Cough?

    * 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".