NDC 53499-8393 Childrens Cough And Bronchial

Antimony Pentasulfide,Bryonia Alba Root,Drosera Rotundifolia,Eucalyptus Globulus - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
53499-8393
Proprietary Name:
Childrens Cough And Bronchial
Non-Proprietary Name: [1]
Antimony Pentasulfide, Bryonia Alba Root, Drosera Rotundifolia, Eucalyptus Globulus Leaf, Ipecac, Illicium Anisatum Whole
Substance Name: [2]
Antimony Pentasulfide; Bryonia Alba Root; Drosera Rotundifolia Flowering Top; Eucalyptus Globulus Leaf; Illicium Anisatum Whole; Ipecac
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
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    04-18-2017
    End Marketing Date: [10]
    03-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 53499-8393-5

    Package Description: 1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC

    NDC Code 53499-8393-9

    Package Description: 1 BOTTLE, PLASTIC in 1 BOX / 237 mL in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 53499-8393?

    The NDC code 53499-8393 is assigned by the FDA to the product Childrens Cough And Bronchial which is a human over the counter drug product labeled by Schwabe North America, Inc. The generic name of Childrens Cough And Bronchial is antimony pentasulfide, bryonia alba root, drosera rotundifolia, eucalyptus globulus leaf, ipecac, illicium anisatum whole. The product's dosage form is syrup and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 53499-8393-5 1 bottle, plastic in 1 box / 118 ml in 1 bottle, plastic, 53499-8393-9 1 bottle, plastic in 1 box / 237 ml in 1 bottle, plastic. 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 Childrens Cough And Bronchial?

    Indications and Usage:Temporarily relieves coughs due to minor throat and bronchial irritations as may occur with a cold.Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.Soothes the throat.

    What are Childrens Cough And Bronchial 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.

    * 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.

    [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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".