Neorelief For Menstrual Pain And Cramps

Homeopathic Pain Relief Gel

Biolyte Laboratories, Llc
Human Otc Drug
NDC 58368-003

Neorelief For Menstrual Pain And Cramps also known as Homeopathic Pain Relief Gel is a human otc drug labeled by 'Biolyte Laboratories, Llc'. National Drug Code (NDC) number for Neorelief For Menstrual Pain And Cramps is 58368-003. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Neorelief For Menstrual Pain And Cramps drug includes Apis Mellifera - 4 [hp_X]/g Arnica Montana - 4 [hp_X]/g Atropa Belladonna - 4 [hp_X]/g Bellis Perennis - 4 [hp_X]/g Black Cohosh - 4 [hp_X]/g Bryonia Alba Root - 4 [hp_X]/g Caulophyllum Thalictroides Root - 4 [hp_X]/g Citrullus Colocynthis Fruit Pulp - 4 [hp_X]/g Cyclamen Purpurascens Tuber - 4 [hp_X]/g Frangula Californica Bark - 4 [hp_X]/g and more. The currest status of Neorelief For Menstrual Pain And Cramps drug is Active.

Drug Information:

Drug NDC:	58368-003
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Neorelief For Menstrual Pain And Cramps
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Homeopathic Pain Relief Gel
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Biolyte Laboratories, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	APIS MELLIFERA - 4 [hp_X]/g ARNICA MONTANA - 4 [hp_X]/g ATROPA BELLADONNA - 4 [hp_X]/g BELLIS PERENNIS - 4 [hp_X]/g BLACK COHOSH - 4 [hp_X]/g BRYONIA ALBA ROOT - 4 [hp_X]/g CAULOPHYLLUM THALICTROIDES ROOT - 4 [hp_X]/g CITRULLUS COLOCYNTHIS FRUIT PULP - 4 [hp_X]/g CYCLAMEN PURPURASCENS TUBER - 4 [hp_X]/g FRANGULA CALIFORNICA BARK - 4 [hp_X]/g Load more... GELSEMIUM SEMPERVIRENS ROOT - 4 [hp_X]/g JUNIPERUS SABINA LEAFY TWIG - 4 [hp_X]/g LILIUM LANCIFOLIUM WHOLE FLOWERING - 4 [hp_X]/g POTASSIUM CARBONATE - 4 [hp_X]/g SARACA INDICA BARK - 4 [hp_X]/g SELENICEREUS GRANDIFLORUS STEM - 4 [hp_X]/g TILIA X EUROPAEA FLOWER - 4 [hp_X]/g VIBURNUM OPULUS BARK - 4 [hp_X]/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	27 Apr, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	24 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	BioLyte Laboratories, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000185021 N0000175629 N0000184306 N0000185001 M0000728 M0002274
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	7S82P3R43Z O80TY208ZW WQZ3G9PF0H 2HU33I03UY K73E24S6X9 T7J046YI2B JTJ6HH6YEH 23H32AOH17 G728143D8Q 1LZ13MQR0S Load more... 639KR60Q1Q Z5BEX9K2G1 X67Z2963PI BQN1B9B9HA 341ALE870W 7114SV0MYK NHV2K1OUDH T1UG6H6805
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Standardized Insect Venom Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS] Bee Venoms [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Bee Venoms [CS] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Standardized Insect Venom Allergenic Extract [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
58368-003-03	1 BOTTLE, PUMP in 1 CARTON (58368-003-03) / 14.17 g in 1 BOTTLE, PUMP	27 Apr, 2018	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Neorelief For Menstrual Pain And Cramps

Homeopathic Pain Relief Gel

Gel
BioLyte Laboratories, LLC
NDC: 58368-003

Purpose:

Purpose topical analgesics relief of cramping anti-inflammatory

Product Elements:

Neorelief for menstrual pain and cramps homeopathic pain relief gel citric acid monohydrate potassium sorbate sodium hydroxide carbomer homopolymer type c (allyl pentaerythritol crosslinked) fulvic acid glycerin water potassium carbonate carbonate ion frangula californica bark frangula californica bark arnica montana arnica montana atropa belladonna atropa belladonna bryonia alba root bryonia alba root black cohosh black cohosh cyclamen purpurascens tuber cyclamen purpurascens tuber saraca indica bark saraca indica bark lilium lancifolium whole flowering lilium lancifolium whole flowering juniperus sabina leafy twig juniperus sabina leafy twig bellis perennis bellis perennis selenicereus grandiflorus stem selenicereus grandiflorus stem caulophyllum thalictroides root caulophyllum thalictroides root citrullus colocynthis fruit pulp citrullus colocynthis fruit pulp gelsemium sempervirens root gelsemium sempervirens root viburnum opulus bark viburnum opulus bark tilia x europaea flower tilia x europaea flower apis mellifera apis mellifera

Indications and Usage:

Uses for temporary relief of menstrual symptoms such as: menstrual pain, cramping indications are based on homeopathic materia medica, not clinical tests.

Warnings:

Warnings for external use only do not use on damged or broken skin. keep out of eyes, open wounds, mucous membranes

Dosage and Administration:

Directions 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.

Package Label Principal Display Panel:

Neorelief for menstrual pain and cramps ndc 58368-003-03 patent pending neo relief temporary relief of menstrual pain & cramps homeopathic pain relief gel net wt. 0.5 oz (14.17g) neorelief_menstural

Further Questions:

Questions or comments? 800.538.1455 monday through friday, 8 a.m. - 5 p.m. est or visit us at neorelief.com. reporty any serious side effects to the number above.

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.