1. Home
  2. Labeler Index
  3. Biolyte Laboratories, Llc
  4. NDC Product Code: 58368-005 Neorelief For Pain

NDC 58368-005 Neorelief For Pain

Topical Gel For Pain Gel Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 58368-005?
  4. Neorelief For Pain Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
58368-005
Proprietary Name:
Neorelief For Pain
Non-Proprietary Name: [1]
Topical Gel For Pain
Substance Name: [2]
Actaea Spicata Root; Althaea Officinalis Root; Arnica Montana; Atropa Belladonna Root; Bellis Perennis; Black Cohosh; Bryonia Alba Root; Calendula Officinalis Flowering Top; Caulophyllum Thalictroides Root; Causticum; Frangula Californica Bark; Guaiacum Officinale Resin; Horse Chestnut; Hypericum Perforatum; Ledum Palustre Twig; Lithium Carbonate; Potassium Carbonate; Rhododendron Aureum Leaf; Ruta Graveolens Flowering Top; Salicylic Acid; Stellaria Media; Toxicodendron Pubescens Leaf
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 Name: [5]
    Biolyte Laboratories, Llc
    Labeler Code:
    58368
    Product Label ID:
    46df076d-4e3a-6faa-e054-00144ff8d46c
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    02-01-2017
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 58368-005?

    The NDC code 58368-005 is assigned by the FDA to the product Neorelief For Pain which is a human over the counter drug product labeled by Biolyte Laboratories, Llc. The generic name of Neorelief For Pain is topical gel for pain. The product's dosage form is gel and is administered via topical form. The product is distributed in a single package with assigned NDC code 58368-005-01 1 bottle, pump in 1 carton / 56.7 g 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 Neorelief For Pain?

    Adults and children 2 years of age and older, apply a thin layer of gel on clean skin to cover the affected area.For best results, allow gel to be absorbed into the skin;do not rub in.Apply at the onset of symptoms, not more than 6 times daily or every 15 minutes for the first hour.Do not use with other topical remedies or lotions.

    What are Neorelief For Pain 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 Neorelief For Pain UNII Codes?

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

    Which are Neorelief For Pain 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 Neorelief For Pain?

    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".