Snore Control

Bromium, Chamomilla, Cinchona Officinalis, Cuprum Metallicum, Helleborus Niger, Laurocerasus, Nux Vomica, Phosphoricum Acidum, Rhus Tox, Silicea, Stramonium, Zincum Metallicum.


King Bio Inc.
Human Otc Drug
NDC 57955-5122
Snore Control also known as Bromium, Chamomilla, Cinchona Officinalis, Cuprum Metallicum, Helleborus Niger, Laurocerasus, Nux Vomica, Phosphoricum Acidum, Rhus Tox, Silicea, Stramonium, Zincum Metallicum. is a human otc drug labeled by 'King Bio Inc.'. National Drug Code (NDC) number for Snore Control is 57955-5122. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Snore Control drug includes Bromine - 10 [hp_X]/59mL Cinchona Officinalis Bark - 10 [hp_X]/59mL Copper - 10 [hp_X]/59mL Datura Stramonium - 10 [hp_X]/59mL Helleborus Niger Root - 10 [hp_X]/59mL Matricaria Chamomilla Whole - 10 [hp_X]/59mL Phosphoric Acid - 10 [hp_X]/59mL Prunus Laurocerasus Leaf - 10 [hp_X]/59mL Silicon Dioxide - 10 [hp_X]/59mL Strychnos Nux-vomica Seed - 10 [hp_X]/59mL and more. The currest status of Snore Control drug is Active.

Drug Information:

Drug NDC: 57955-5122
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: Snore Control
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: Bromium, Chamomilla, Cinchona Officinalis, Cuprum Metallicum, Helleborus Niger, Laurocerasus, Nux Vomica, Phosphoricum Acidum, Rhus Tox, Silicea, Stramonium, Zincum Metallicum.
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:BROMINE - 10 [hp_X]/59mL
CINCHONA OFFICINALIS BARK - 10 [hp_X]/59mL
COPPER - 10 [hp_X]/59mL
DATURA STRAMONIUM - 10 [hp_X]/59mL
HELLEBORUS NIGER ROOT - 10 [hp_X]/59mL
MATRICARIA CHAMOMILLA WHOLE - 10 [hp_X]/59mL
PHOSPHORIC ACID - 10 [hp_X]/59mL
PRUNUS LAUROCERASUS LEAF - 10 [hp_X]/59mL
SILICON DIOXIDE - 10 [hp_X]/59mL
STRYCHNOS NUX-VOMICA SEED - 10 [hp_X]/59mL
TOXICODENDRON PUBESCENS LEAF - 10 [hp_X]/59mL
ZINC - 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: 06 Dec, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 Jun, 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:M0005152
N0000175831
N0000008595
N0000008924
N0000175830
N0000185375
N0000175629
N0000184306
N0000185001
M0000728
M0016962
M0516536
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:SBV4XY874G
S003A158SB
789U1901C5
G6W4F0V8Z3
608DGJ6815
G0R4UBI2ZZ
E4GA8884NN
F26P2D4757
ETJ7Z6XBU4
269XH13919
6IO182RP7A
J41CSQ7QDS
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:Copper-containing Intrauterine Device [EPC]
Non-Standardized Plant 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:Decreased Embryonic Implantation [PE]
Decreased Sperm Motility [PE]
Inhibit Ovum Fertilization [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:Copper [CS]
Allergens [CS]
Plant Proteins [CS]
Seed Storage Proteins [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]
Cell-mediated Immunity [PE]
Copper [CS]
Copper-containing Intrauterine Device [EPC]
Decreased Embryonic Implantation [PE]
Decreased Sperm Motility [PE]
Increased Histamine Release [PE]
Increased IgG Production [PE]
Inhibit Ovum Fertilization [PE]
Non-Standardized Plant Allergenic Extract [EPC]
Plant Proteins [CS]
Seed Storage Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
57955-5122-21 BOTTLE, SPRAY in 1 CARTON (57955-5122-2) / 59 mL in 1 BOTTLE, SPRAY06 Dec, 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:

Active ingredients purpose † equal volumes of each hpus** ingredient in 10x, 30x, and 1lm potencies. bromium ................................... jerking and starting during sleep chamomilla .....................................................tightness of chest cinchona officinalis ...................................slow, labored breathing cuprum metallicum .............................................spasms of chest helleborus niger..............................................irregular respiration laurocerasus ...................................spasmodic tickling, dry cough nux vomica ....................................stuffy nose, especially at night phosphoricum acidum.........................................difficult breathing rhus tox .................................heaviness of chest, bronchial cough silicea.....................................................coughs when lying down stramonium............................................................ deep snoring zincum metallicum .....................................................hoarseness **“hpus” indicates the active ingredients are in the official homeopathic pharmacopeia of the united states. reference image:snore control.jpg

Product Elements:

Snore control bromium, chamomilla, cinchona officinalis, cuprum metallicum, helleborus niger, laurocerasus, nux vomica, phosphoricum acidum, rhus tox, silicea, stramonium, zincum metallicum. bromine bromine matricaria chamomilla whole matricaria chamomilla cinchona officinalis bark cinchona officinalis bark copper copper helleborus niger root helleborus niger root prunus laurocerasus leaf prunus laurocerasus leaf strychnos nux-vomica seed strychnos nux-vomica seed phosphoric acid phosphoric acid toxicodendron pubescens leaf toxicodendron pubescens leaf silicon dioxide silicon dioxide datura stramonium datura stramonium zinc zinc 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 symptoms related to snoring: slow, labored breathing stuffy nose, especially at night heaviness of chest dry cough 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:snore control.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:snore control.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:snore control.jpg

Package Label Principal Display Panel:

Image description snore control.jpg


Comments/ Reviews:

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