NDC 63936-8700 Stopain Migraine Pain Relieving

Mentholum,Belladonna,Iris Versicolor,Sanguinaria Canadensis Gel Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
63936-8700
Proprietary Name:
Stopain Migraine Pain Relieving
Non-Proprietary Name: [1]
Mentholum, Belladonna, Iris Versicolor, Sanguinaria Canadensis
Substance Name: [2]
Atropa Belladonna; Iris Versicolor Root; Menthol, Unspecified Form; Sanguinaria Canadensis Root
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Code:
    63936
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    03-20-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 63936-8700?

    The NDC code 63936-8700 is assigned by the FDA to the product Stopain Migraine Pain Relieving which is a human over the counter drug product labeled by Troy Manufacturing, Inc. The generic name of Stopain Migraine Pain Relieving is mentholum, belladonna, iris versicolor, sanguinaria canadensis. The product's dosage form is gel and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 63936-8700-1 1 bottle, pump in 1 carton / 50 ml in 1 bottle, pump, 63936-8700-2 50 ml in 1 bottle, pump . 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 Stopain Migraine Pain Relieving?

    Adults and children over 12 years Remove cap For first application press down several times to prime actuator pump for use After actuator has been primed press and release pump once to dispense gel onto finger tips Apply to one side on back of neck and behind the ear, repeat for the other side, applying a single pump of product for each side For best results, apply as soon as you feel discomfort If after 30 minutes the symptoms still persist, reapply as needed, up to 4 times daily See insert for more details

    What are Stopain Migraine Pain Relieving 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 Stopain Migraine Pain Relieving UNII Codes?

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

    Which are Stopain Migraine Pain Relieving 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:

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    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".