1. Home
  2. Labeler Index
  3. Kobizstar Co., Ltd.
  4. NDC Product Code: 81077-020 Solep Premier Hi Gro Tonic

NDC 81077-020 Solep Premier Hi Gro Tonic

Menthol,Panthenol,Salicylic Acid Spray Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 81077-020?
  4. Solep Premier Hi Gro Tonic Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
81077-020
Proprietary Name:
Solep Premier Hi Gro Tonic
Non-Proprietary Name: [1]
Menthol, Panthenol, Salicylic Acid
Substance Name: [2]
Menthol; Panthenol; Salicylic Acid
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
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]
    Kobizstar Co., Ltd.
    Labeler Code:
    81077
    Product Label ID:
    be18abc9-df84-4455-a26e-470841af30c6
    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]
    11-01-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 81077-020-02

    Package Description: 1 BOTTLE, SPRAY in 1 CARTON / 100 mL in 1 BOTTLE, SPRAY (81077-020-01)

    Product Details

    What is NDC 81077-020?

    The NDC code 81077-020 is assigned by the FDA to the product Solep Premier Hi Gro Tonic which is a human over the counter drug product labeled by Kobizstar Co., Ltd.. The generic name of Solep Premier Hi Gro Tonic is menthol, panthenol, salicylic acid. The product's dosage form is spray and is administered via topical form. The product is distributed in a single package with assigned NDC code 81077-020-02 1 bottle, spray in 1 carton / 100 ml in 1 bottle, spray (81077-020-01). 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 Solep Premier Hi Gro Tonic?

    ■ Shake the product before use, daily apply adequate amount and gently massage the scalp with fingertips to be fully absorbed.

    What are Solep Premier Hi Gro Tonic 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 Solep Premier Hi Gro Tonic UNII Codes?

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

    Which are Solep Premier Hi Gro Tonic 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.

    [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".