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  4. NDC Product Code: 52053-0004 Sambucol Cold And Flu Relief

NDC 52053-0004 Sambucol Cold And Flu Relief

Bryonia,Gelsemium Sempervirens,Sabucus Nigra,Sulphur,Zincum Gluconicum Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52053-0004?
  5. Sambucol Cold And Flu Relief Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

NDC Product Code:
52053-0004
Proprietary Name:
Sambucol Cold And Flu Relief
Non-Proprietary Name: [1]
Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum
Substance Name: [2]
Bryonia Alba Root; Gelsemium Sempervirens Root; Sambucus Nigra Flowering Top; Sulfur; Zinc Gluconate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Pharmacare Us, Inc.
    Labeler Code:
    52053
    Product Label ID:
    7dace656-ee97-4931-869f-8c8022757abb
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    10-04-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PURPLE (C48327 - OFF PURPLE OFF GREY COLOR WITH SPECKS)
    Shape:
    ROUND (C48348)
    Size(s):
    10 MM
    Imprint(s):
    SCF
    Score:
    1
    Flavor(s):
    BERRY (C73365 - ELDERBERRY)

    Product Packages

    NDC Code 52053-0004-1

    Package Description: 4 BLISTER PACK in 1 CARTON / 4500 mg in 1 BLISTER PACK (52053-0004-2)

    Product Details

    What is NDC 52053-0004?

    The NDC code 52053-0004 is assigned by the FDA to the product Sambucol Cold And Flu Relief which is a human over the counter drug product labeled by Pharmacare Us, Inc.. The generic name of Sambucol Cold And Flu Relief is bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 52053-0004-1 4 blister pack in 1 carton / 4500 mg in 1 blister pack (52053-0004-2). 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 Sambucol Cold And Flu Relief?

    •Temporarily relieves cold and flu symptoms.• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal and sinus congestion, minor sore throat and   headache.• Also temporarily relieves fever, chills, and body aches associated with the flu.Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. •Temporarily relieves cold and flu symptoms.• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal and sinus congestion, minor sore throat andheadache.• Also temporarily relieves fever, chills, and body aches associated with the flu.Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

    What are Sambucol Cold And Flu Relief 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 Sambucol Cold And Flu Relief UNII Codes?

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

    Which are Sambucol Cold And Flu Relief 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:

    Which are the Pharmacologic Classes for Sambucol Cold And Flu Relief?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * 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".