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  4. NDC Product Code: 53499-9803 Sambucus Flucare

NDC 53499-9803 Sambucus Flucare

Aconitum Napellus,Bryonia Alba Root,Eucalyptus Globulus Leaf,Eupatorium Perfoliatum - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 53499-9803?
  5. Sambucus Flucare Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
53499-9803
Proprietary Name:
Sambucus Flucare
Non-Proprietary Name: [1]
Aconitum Napellus, Bryonia Alba Root, Eucalyptus Globulus Leaf, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Ipecac, Phosphorus, Sambucus Nigra Flowering Top
Substance Name: [2]
Aconitum Napellus; Bryonia Alba Root; Eucalyptus Globulus Leaf; Eupatorium Perfoliatum Flowering Top; Gelsemium Sempervirens Root; Ipecac; Phosphorus; Sambucus Nigra Flowering Top
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:
    fd0a4450-f003-44f4-85e6-d1b14ef35b89
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    10-03-2017
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Flavor(s):
    RASPBERRY (C73413 - NATURAL RASPBERRY FLAVOR)

    Code Structure Chart

    Product Details

    What is NDC 53499-9803?

    The NDC code 53499-9803 is assigned by the FDA to the product Sambucus Flucare which is a human over the counter drug product labeled by Schwabe North America, Inc.. The generic name of Sambucus Flucare is aconitum napellus, bryonia alba root, eucalyptus globulus leaf, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, phosphorus, sambucus nigra flowering top. 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 53499-9803-5 1 bottle, plastic in 1 box / 120 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 Sambucus Flucare?

    Indication and Usage:Temporarily relieves common flu symptoms: chills and fevers, congestion, cough, headache, hoarseness, runny nose, sore throat, stuffy nose, sneezing, minor aches and pains.

    What are Sambucus Flucare 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 Sambucus Flucare UNII Codes?

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

    Which are Sambucus Flucare 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:

    * 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.

    [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".