1. Home
  2. Labeler Index
  3. Biolyte Laboratories, Llc
  4. NDC Product Code: 58368-003 Neorelief For Menstrual Pain And Cramps

NDC 58368-003 Neorelief For Menstrual Pain And Cramps

Homeopathic Pain Relief Gel Gel Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 58368-003?
  4. Neorelief For Menstrual Pain And Cramps Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
58368-003
Proprietary Name:
Neorelief For Menstrual Pain And Cramps
Non-Proprietary Name: [1]
Homeopathic Pain Relief Gel
Substance Name: [2]
Apis Mellifera; Arnica Montana; Atropa Belladonna; Bellis Perennis; Black Cohosh; Bryonia Alba Root; Caulophyllum Thalictroides Root; Citrullus Colocynthis Fruit Pulp; Cyclamen Purpurascens Tuber; Frangula Californica Bark; Gelsemium Sempervirens Root; Juniperus Sabina Leafy Twig; Lilium Lancifolium Whole Flowering; Potassium Carbonate; Saraca Indica Bark; Selenicereus Grandiflorus Stem; Tilia X Europaea Flower; Viburnum Opulus Bark
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:
    71c2a2f7-4823-51cb-e053-2995a90a5fb8
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    04-27-2018
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 58368-003?

    The NDC code 58368-003 is assigned by the FDA to the product Neorelief For Menstrual Pain And Cramps which is a human over the counter drug product labeled by Biolyte Laboratories, Llc. The generic name of Neorelief For Menstrual Pain And Cramps is homeopathic pain relief gel. 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 58368-003-03 1 bottle, pump in 1 carton / 14.17 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 Menstrual Pain And Cramps?

    Women ages 8 years and older, spread thin layer on lower abdomen and lower back.Do not apply over other topical lotions; they may hinder effectiveness.Apply as needed for relief.

    What are Neorelief For Menstrual Pain And Cramps 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 Menstrual Pain And Cramps UNII Codes?

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

    • POTASSIUM CARBONATE (UNII: BQN1B9B9HA)
    • CARBONATE ION (UNII: 7UJQ5OPE7D) (Active Moiety)
    • FRANGULA CALIFORNICA BARK (UNII: 1LZ13MQR0S)
    • FRANGULA CALIFORNICA BARK (UNII: 1LZ13MQR0S) (Active Moiety)
    • ARNICA MONTANA (UNII: O80TY208ZW)
    • ARNICA MONTANA (UNII: O80TY208ZW) (Active Moiety)
    • ATROPA BELLADONNA (UNII: WQZ3G9PF0H)
    • ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (Active Moiety)
    • BRYONIA ALBA ROOT (UNII: T7J046YI2B)
    • BRYONIA ALBA ROOT (UNII: T7J046YI2B) (Active Moiety)
    • BLACK COHOSH (UNII: K73E24S6X9)
    • BLACK COHOSH (UNII: K73E24S6X9) (Active Moiety)
    • CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q)
    • CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (Active Moiety)
    • SARACA INDICA BARK (UNII: 341ALE870W)
    • SARACA INDICA BARK (UNII: 341ALE870W) (Active Moiety)
    • LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI)
    • LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (Active Moiety)
    • JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1)
    • JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (Active Moiety)
    • BELLIS PERENNIS (UNII: 2HU33I03UY)
    • BELLIS PERENNIS (UNII: 2HU33I03UY) (Active Moiety)
    • SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK)
    • SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (Active Moiety)
    • CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)
    • CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (Active Moiety)
    • CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17)
    • CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (Active Moiety)
    • GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q)
    • GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (Active Moiety)
    • VIBURNUM OPULUS BARK (UNII: T1UG6H6805)
    • VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (Active Moiety)
    • TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)
    • TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH) (Active Moiety)
    • APIS MELLIFERA (UNII: 7S82P3R43Z)
    • APIS MELLIFERA (UNII: 7S82P3R43Z) (Active Moiety)

    Which are Neorelief For Menstrual Pain And Cramps 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 Menstrual Pain And Cramps?

    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".