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  4. NDC Product Code: 82871-301 Stomasin

NDC 82871-301 Stomasin

Gypsum Fibrosum Extract,Forsythia Viridissima Fruit Extract,Arctium Lappa Fruit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 82871-301?
  5. Stomasin Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

NDC Product Code:
82871-301
Proprietary Name:
Stomasin
Non-Proprietary Name: [1]
Gypsum Fibrosum Extract, Forsythia Viridissima Fruit Extract, Arctium Lappa Fruit Extract, Platycodon Grandiflorus Root Extract, Saposhnikovia Divaricata Root Extract, Glycyrrhiza Uralensis Root Extract, Ostericum Koreanum Extract, Schizonepeta Tenuifolia Extract
Substance Name: [2]
Arctium Lappa Fruit; Calcium Sulfate, Unspecified Form; Forsythia Viridissima Fruit; Glycyrrhiza Uralensis Root; Nepeta Tenuifolia Flowering Top; Ostericum Grosseserratum Root; Platycodon Grandiflorum Root; Saposhnikovia Divaricata Root
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Medicarebio.co.ltd
    Labeler Code:
    82871
    Product Label ID:
    e3ac2145-22c6-eefe-e053-2995a90aaf17
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    07-13-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333 - BLUE AND DARK GREEN CAPSULE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    22 MM

    Code Structure Chart

    Product Details

    What is NDC 82871-301?

    The NDC code 82871-301 is assigned by the FDA to the product Stomasin which is a human over the counter drug product labeled by Medicarebio.co.ltd. The generic name of Stomasin is gypsum fibrosum extract, forsythia viridissima fruit extract, arctium lappa fruit extract, platycodon grandiflorus root extract, saposhnikovia divaricata root extract, glycyrrhiza uralensis root extract, ostericum koreanum extract, schizonepeta tenuifolia extract. The product's dosage form is capsule, coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 82871-301-01 10 capsule, coated 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 Stomasin?

    Adults Take 2 capsules per time, 3 times a day Children 7 years to under 14 years 2/3 of the adult dose (4/3 capsules) Children 4 years to under 6 years 1/2 of the adult dose (1 capsule) Children 2 years to under 3 years 1/3 of the adult dose (2/3 capsule) Children under 1 years 1/4 of the adult dose (1/2 capsule) Dissolve it in lukewarm water before or between meals (between meals and between meals) and take it slowly in small portions while moistening the mouth or throat (do not swallow capsules).

    What are Stomasin 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 Stomasin UNII Codes?

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

    • OSTERICUM GROSSESERRATUM ROOT (UNII: 9IGM98814N)
    • OSTERICUM GROSSESERRATUM ROOT (UNII: 9IGM98814N) (Active Moiety)
    • CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)
    • CALCIUM CATION (UNII: 2M83C4R6ZB) (Active Moiety)
    • FORSYTHIA VIRIDISSIMA FRUIT (UNII: P4ZY00SWES)
    • FORSYTHIA VIRIDISSIMA FRUIT (UNII: P4ZY00SWES) (Active Moiety)
    • ARCTIUM LAPPA FRUIT (UNII: EA541308MV)
    • ARCTIUM LAPPA FRUIT (UNII: EA541308MV) (Active Moiety)
    • PLATYCODON GRANDIFLORUM ROOT (UNII: 2DF0NS0O2Z)
    • PLATYCODON GRANDIFLORUM ROOT (UNII: 2DF0NS0O2Z) (Active Moiety)
    • SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
    • SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD) (Active Moiety)
    • NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)
    • NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE) (Active Moiety)
    • GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
    • GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K) (Active Moiety)

    Which are Stomasin 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 Stomasin?

    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".