Headache Relief

Belladonna, Bryonia, Capsicum Annuum, Chininum Arsenicosum, Coffea Cruda, Gelsemium Sempervirens, Glonoinum, Ignatia Amara, Kali Bichromicum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Sanguinaria Canadensis, Spigelia Anthelmia, Sulphur


King Bio Inc.
Human Otc Drug
NDC 57955-2830
Headache Relief also known as Belladonna, Bryonia, Capsicum Annuum, Chininum Arsenicosum, Coffea Cruda, Gelsemium Sempervirens, Glonoinum, Ignatia Amara, Kali Bichromicum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Sanguinaria Canadensis, Spigelia Anthelmia, Sulphur is a human otc drug labeled by 'King Bio Inc.'. National Drug Code (NDC) number for Headache Relief is 57955-2830. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Headache Relief drug includes Arabica Coffee Bean - 10 [hp_X]/59mL Atropa Belladonna - 10 [hp_X]/59mL Bryonia Alba Root - 10 [hp_X]/59mL Capsicum - 10 [hp_X]/59mL Gelsemium Sempervirens Root - 10 [hp_X]/59mL Lycopodium Clavatum Spore - 10 [hp_X]/59mL Nitroglycerin - 10 [hp_X]/59mL Potassium Dichromate - 10 [hp_X]/59mL Quinine Arsenite - 10 [hp_X]/59mL Sanguinaria Canadensis Root - 10 [hp_X]/59mL and more. The currest status of Headache Relief drug is Active.

Drug Information:

Drug NDC: 57955-2830
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: Headache Relief
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: Belladonna, Bryonia, Capsicum Annuum, Chininum Arsenicosum, Coffea Cruda, Gelsemium Sempervirens, Glonoinum, Ignatia Amara, Kali Bichromicum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Sanguinaria Canadensis, Spigelia Anthelmia, Sulphur
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: King Bio Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
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:ARABICA COFFEE BEAN - 10 [hp_X]/59mL
ATROPA BELLADONNA - 10 [hp_X]/59mL
BRYONIA ALBA ROOT - 10 [hp_X]/59mL
CAPSICUM - 10 [hp_X]/59mL
GELSEMIUM SEMPERVIRENS ROOT - 10 [hp_X]/59mL
LYCOPODIUM CLAVATUM SPORE - 10 [hp_X]/59mL
NITROGLYCERIN - 10 [hp_X]/59mL
POTASSIUM DICHROMATE - 10 [hp_X]/59mL
QUININE ARSENITE - 10 [hp_X]/59mL
SANGUINARIA CANADENSIS ROOT - 10 [hp_X]/59mL
SODIUM CHLORIDE - 10 [hp_X]/59mL
SPIGELIA ANTHELMIA WHOLE - 10 [hp_X]/59mL
STRYCHNOS IGNATII SEED - 10 [hp_X]/59mL
STRYCHNOS NUX-VOMICA SEED - 10 [hp_X]/59mL
SULFUR - 10 [hp_X]/59mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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: 22 Jul, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 08 May, 2026
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, 2023
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:King Bio Inc.
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:N0000185371
N0000185375
N0000175629
N0000184306
M0000728
M0006342
M0016962
M0516536
M0022575
N0000175415
M0014874
N0000009909
N0000185001
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:3SW678MX72
WQZ3G9PF0H
T7J046YI2B
00UK7646FG
639KR60Q1Q
C88X29Y479
G59M7S0WS3
T4423S18FM
42QO5P0NLM
N9288CD508
451W47IQ8X
WYT05213GE
1NM3M2487K
269XH13919
70FD1KFU70
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:Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Nitrate Vasodilator [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]
Vasodilation [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]
Dietary Proteins [CS]
Plant Proteins [CS]
Seed Storage Proteins [CS]
Vegetable Proteins [CS]
Nitrates [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]
Antimalarial [EPC]
Cell-mediated Immunity [PE]
Dietary Proteins [CS]
Increased Histamine Release [PE]
Increased IgG Production [PE]
Nitrate Vasodilator [EPC]
Nitrates [CS]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Plant Proteins [CS]
Seed Storage Proteins [CS]
Vasodilation [PE]
Vegetable Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
57955-2830-21 BOTTLE, SPRAY in 1 CARTON (57955-2830-2) / 59 mL in 1 BOTTLE, SPRAY27 Jul, 2022N/ANo
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.

Purpose:

Equal volumes of each hpus** ingredient in 10x, 30x, and 1lm potencies. belladonna .......................................throbbing in head and eyes bryonia ...................................splitting headache, sinus pressure capsicum annuum .............................bursting headache, hot face chininum arsenicosum............................................dull headache coffea cruda........................................................tight head pain gelsemium sempervirens....................... band feeling around head glonoinum ............................................................sun headache ignatia amara ........................................... congestive headaches kali bichromicum ....................................headache over eyebrows lycopodium clavatum............................................pain in temples natrum muriaticum ...........................throbbing, blinding headache nux vomica.............................................headache from sunshine sanguinaria canadensis ........................................burning in eyes spigelia anthelmia ...........................pain as if a band around head sulphur....................................sick headache, pressure in temples **“hpus” indicates the active ingredients are in the official homeopathic pharmacopeia of the united states. reference image:headache relief.jpg

Product Elements:

Headache relief belladonna, bryonia, capsicum annuum, chininum arsenicosum, coffea cruda, gelsemium sempervirens, glonoinum, ignatia amara, kali bichromicum, lycopodium clavatum, natrum muriaticum, nux vomica, sanguinaria canadensis, spigelia anthelmia, sulphur atropa belladonna atropa belladonna bryonia alba root bryonia alba root capsicum capsicum quinine arsenite quinine arabica coffee bean arabica coffee bean gelsemium sempervirens root gelsemium sempervirens root nitroglycerin nitroglycerin strychnos ignatii seed strychnos ignatii seed potassium dichromate dichromate ion lycopodium clavatum spore lycopodium clavatum spore sodium chloride chloride ion strychnos nux-vomica seed strychnos nux-vomica seed sanguinaria canadensis root sanguinaria canadensis root spigelia anthelmia whole spigelia anthelmia sulfur sulfur ascorbic acid citric acid monohydrate citrus aurantium fruit oil orange peel citrus reticulata fruit oil water glycerin lactic acid, unspecified form lonicera japonica flower benzylpenicilloyl polylysine carya ovata bark steviol

Indications and Usage:

Uses uses for temporary relief of various types of headache, such as: throbbing splitting tight dull sick bursting sinus congestive migraine occipital morning headache band feeling around the head sun headache as per various homeopathic materia medicas. claims based on traditional homeopathic practice, not accepted medical evidence. these uses have not been evaluated by the fda, and product has not been clinically tested. reference image:headache relief.jpg

Warnings:

Warnings stop use and consult a physician if symptoms worsen or persist for more than 7 days. if pregnant or breast-feeding , ask a healthcare professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center immediately. reference image:headache relief.jpg

Dosage and Administration:

Directions initially, depress pump until primed. spray one dose directly into mouth. adults: 3 sprays 3 times per day. children ages 6-12: 2 sprays 3 times per day. consult a physician for use in children under 6 years of age. use additionally as needed, up to 6 times per day. reference image:headache relief.jpg

Package Label Principal Display Panel:

Image description headache relief.jpg


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.