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  4. NDC Product Code: 53499-6864 Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root

NDC 53499-6864 Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root

Syrup Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 53499-6864?
  4. Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
53499-6864
Proprietary Name:
Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root
Non-Proprietary Name: [1]
Cough Relief
Substance Name: [2]
Aconitum Napellus; Bryonia Alba Root; Calcium Sulfide; Pelargonium Sidoides Root; Spongia Officinalis Skeleton, Roasted; Tin
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Schwabe North America, Inc.
    Labeler Code:
    53499
    Product Label ID:
    a95610e3-774b-4745-a2a4-fc3ba51ab4c5
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    01-19-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 53499-6864?

    The NDC code 53499-6864 is assigned by the FDA to the product Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root which is a human over the counter drug product labeled by Schwabe North America, Inc.. The product's dosage form is syrup and is administered via oral form. The product is distributed in a single package with assigned NDC code 53499-6864-4 1 bottle in 1 box / 120 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 Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root?

    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 Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root 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.

    Which are Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root UNII Codes?

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

    Which are Cough Relief Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root 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:

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    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.

    [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".