NDC 83404-301 K-power Patch

Achyranthes Bidentata Extract,Achyranthes Bidentata Extract,Patch Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
83404-301
Proprietary Name:
K-power Patch
Non-Proprietary Name: [1]
Achyranthes Bidentata Extract, Achyranthes Bidentata Extract,
Substance Name: [2]
Achyranthes Bidentata Whole; Capsaicin; Eucommia Ulmoides Whole; Harpagophytum Procumbens Whole; Lithospermum Erythrorhizon Whole; Xanthium Strumarium Leaf
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
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 Name: [5]
    Labeler Code:
    83404
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    05-30-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 83404-301?

    The NDC code 83404-301 is assigned by the FDA to the product K-power Patch which is a human over the counter drug product labeled by Bct. The generic name of K-power Patch is achyranthes bidentata extract, achyranthes bidentata extract, . The product's dosage form is patch and is administered via topical form. The product is distributed in a single package with assigned NDC code 83404-301-01 85 mm in 1 patch . 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 K-power Patch?

    ■ use only as directed ■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily ■ children under 12 years of age: ask a doctor

    What are K-power Patch 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 K-power Patch UNII Codes?

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

    • LITHOSPERMUM ERYTHRORHIZON WHOLE (UNII: Y4JMM1JAWJ)
    • LITHOSPERMUM ERYTHRORHIZON WHOLE (UNII: Y4JMM1JAWJ) (Active Moiety)
    • CAPSAICIN (UNII: S07O44R1ZM)
    • CAPSAICIN (UNII: S07O44R1ZM) (Active Moiety)
    • XANTHIUM STRUMARIUM LEAF (UNII: AW4S0K7ELS)
    • XANTHIUM STRUMARIUM LEAF (UNII: AW4S0K7ELS) (Active Moiety)
    • EUCOMMIA ULMOIDES WHOLE (UNII: 21176878UY)
    • EUCOMMIA ULMOIDES WHOLE (UNII: 21176878UY) (Active Moiety)
    • HARPAGOPHYTUM PROCUMBENS WHOLE (UNII: BY51E8JN4B)
    • HARPAGOPHYTUM PROCUMBENS WHOLE (UNII: BY51E8JN4B) (Active Moiety)
    • ACHYRANTHES BIDENTATA WHOLE (UNII: 0B5LIZ2V2H)
    • ACHYRANTHES BIDENTATA WHOLE (UNII: 0B5LIZ2V2H) (Active Moiety)

    Which are K-power Patch 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:

    • WATER (UNII: 059QF0KO0R)
    • DISODIUM DECYL PHENYL ETHER DISULFONATE (UNII: 57S4ZXM7XU)
    • BUTYL ACRYLATE/METHYL METHACRYLATE/PERFLUOROHEXYLETHYL METHACRYLATE COPOLYMER (SALUS AF) (UNII: HLB263IJK9)
    • SCHORL TOURMALINE (UNII: 173O8XLY6T)

    * 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".