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  4. NDC Product Code: 53499-0159 Umcka Cold Flu Berry Chewable

NDC 53499-0159 Umcka Cold Flu Berry Chewable

Pelargonium Sidoides,Aconitum Napellus,Bryonia,Eucalyptus Globulus,Eupatorium - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 53499-0159?
  5. Umcka Cold Flu Berry Chewable Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
53499-0159
Proprietary Name:
Umcka Cold Flu Berry Chewable
Non-Proprietary Name: [1]
Pelargonium Sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus
Substance Name: [2]
Aconitum Napellus; Bryonia Alba Root; Eucalyptus Globulus Leaf; Eupatorium Perfoliatum Flowering Top; Gelsemium Sempervirens Root; Ipecac; Pelargonium Sidoides Root; Phosphorus
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
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:
    3b483993-48b0-415d-8109-b6b4a48e7cda
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    08-21-2017
    End Marketing Date: [10]
    05-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328 - PINK WITH PINKISH-PURPLE SPECKS)
    Shape:
    ROUND (C48348)
    Size(s):
    16 MM
    Imprint(s):
    C
    Score:
    1
    Flavor(s):
    BERRY (C73365 - NATURAL BERRY FLAVOR)

    Product Packages

    NDC Code 53499-0159-0

    Package Description: 2 BLISTER PACK in 1 CARTON / 10 TABLET, CHEWABLE in 1 BLISTER PACK

    Product Details

    What is NDC 53499-0159?

    The NDC code 53499-0159 is assigned by the FDA to the product Umcka Cold Flu Berry Chewable which is a human over the counter drug product labeled by Schwabe North America, Inc.. The generic name of Umcka Cold Flu Berry Chewable is pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 53499-0159-0 2 blister pack in 1 carton / 10 tablet, chewable in 1 blister pack. 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 Umcka Cold Flu Berry Chewable?

    Indications and Usage:Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat.  

    What are Umcka Cold Flu Berry Chewable 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 Umcka Cold Flu Berry Chewable UNII Codes?

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

    Which are Umcka Cold Flu Berry Chewable 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.

    [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".