Neorelief For Menstrual Pain And Cramps Gel
NDC 58368-003

View dosage, usage, ingredients, routes, and UNII mappings.
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

Neorelief For Menstrual Pain And Cramps (homeopathic pain relief gel) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Biolyte Laboratories, Llc. This medication is typically used as a allergens [cs]. It is supplied as a gel for topical administration. This product entry covers the primary NDC 58368-003 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

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.

Marketing Timeline

Start Marketing Date: [9]
04-27-2018
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

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. It is commonly known by its generic name, homeopathic pain relief gel. This pharmaceutical product is labeled by Biolyte Laboratories, Llc and is currently categorized as listed product. The medication is a gel administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 58368-003-03. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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 the associated 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 the Inactive Ingredients associated 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 of this product?

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.

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".