Dentox

Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Stillingia Sylvatica, Trifolium Pratense, Phytolacca Decandra, Lymph Node(suis), Medulla Ossis Suis, Thymus (suis), Thyroidinum (suis), Calcarea Fluorica, Natrum Fluoratum, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum, Niccolum Metallicum, Palladium Metallicum, Stannum Metallicum, Titanium Metallicum, Zincum Metallicum


Bioactive Nutritional, Inc.
Human Otc Drug
NDC 43857-0593
Dentox also known as Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Stillingia Sylvatica, Trifolium Pratense, Phytolacca Decandra, Lymph Node(suis), Medulla Ossis Suis, Thymus (suis), Thyroidinum (suis), Calcarea Fluorica, Natrum Fluoratum, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum, Niccolum Metallicum, Palladium Metallicum, Stannum Metallicum, Titanium Metallicum, Zincum Metallicum is a human otc drug labeled by 'Bioactive Nutritional, Inc.'. National Drug Code (NDC) number for Dentox is 43857-0593. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Dentox drug includes Arctium Lappa Root - 3 [hp_X]/mL Berberis Vulgaris Root Bark - 3 [hp_X]/mL Calcium Fluoride - 12 [hp_X]/mL Copper - 12 [hp_X]/mL Eugenol - 12 [hp_X]/mL Formaldehyde Solution - 12 [hp_X]/mL Glycyrrhiza Glabra - 3 [hp_X]/mL Gold - 12 [hp_X]/mL Lidocaine - 12 [hp_X]/mL Mercurius Solubilis - 12 [hp_X]/mL and more. The currest status of Dentox drug is Active.

Drug Information:

Drug NDC: 43857-0593
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: Dentox
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: Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Stillingia Sylvatica, Trifolium Pratense, Phytolacca Decandra, Lymph Node(suis), Medulla Ossis Suis, Thymus (suis), Thyroidinum (suis), Calcarea Fluorica, Natrum Fluoratum, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum, Niccolum Metallicum, Palladium Metallicum, Stannum Metallicum, Titanium Metallicum, Zincum Metallicum
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Bioactive Nutritional, 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:ARCTIUM LAPPA ROOT - 3 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK - 3 [hp_X]/mL
CALCIUM FLUORIDE - 12 [hp_X]/mL
COPPER - 12 [hp_X]/mL
EUGENOL - 12 [hp_X]/mL
FORMALDEHYDE SOLUTION - 12 [hp_X]/mL
GLYCYRRHIZA GLABRA - 3 [hp_X]/mL
GOLD - 12 [hp_X]/mL
LIDOCAINE - 12 [hp_X]/mL
MERCURIUS SOLUBILIS - 12 [hp_X]/mL
MOLYBDENUM - 12 [hp_X]/mL
NICKEL - 12 [hp_X]/mL
PALLADIUM - 12 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT - 4 [hp_X]/mL
SILVER - 12 [hp_X]/mL
SODIUM FLUORIDE - 12 [hp_X]/mL
STILLINGIA SYLVATICA ROOT - 3 [hp_X]/mL
SUS SCROFA BONE MARROW - 8 [hp_X]/mL
SUS SCROFA LYMPH - 8 [hp_X]/mL
SUS SCROFA THYMUS - 8 [hp_X]/mL
THYROID, PORCINE - 8 [hp_X]/mL
TIN - 12 [hp_X]/mL
TITANIUM - 12 [hp_X]/mL
TRIFOLIUM PRATENSE FLOWER - 3 [hp_X]/mL
ZINC - 12 [hp_X]/mL
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: 14 Feb, 2023
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 05 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, 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:BioActive Nutritional, 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
N0000185508
N0000175629
N0000184306
M0000728
N0000185371
N0000185375
M0006342
M0016962
N0000175682
M0000897
N0000175426
N0000175976
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:597E9BI3Z3
1TH8Q20J0U
O3B55K4YKI
789U1901C5
3T8H1794QW
T0H3L6C7I5
2788Z9758H
79Y1949PYO
98PI200987
324Y4038G2
81AH48963U
7OV03QG267
5TWQ1V240M
11E6VI8VEG
3M4G523W1G
8ZYQ1474W7
QBR70R4FBK
VP2CN2G7Y8
33A7VYU29L
7B69B0BD62
6RV024OAUQ
387GMG9FH5
D1JT611TNE
4JS0838828
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]
Standardized Chemical Allergen [EPC]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Amide Local Anesthetic [EPC]
Antiarrhythmic [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]
Local Anesthesia [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]
Dietary Proteins [CS]
Plant Proteins [CS]
Amides [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]
Amide Local Anesthetic [EPC]
Amides [CS]
Antiarrhythmic [EPC]
Cell-mediated Immunity [PE]
Copper [CS]
Copper-containing Intrauterine Device [EPC]
Decreased Embryonic Implantation [PE]
Decreased Sperm Motility [PE]
Dietary Proteins [CS]
Increased Histamine Release [PE]
Inhibit Ovum Fertilization [PE]
Local Anesthesia [PE]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Plant Proteins [CS]
Standardized Chemical Allergen [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
43857-0593-130 mL in 1 BOTTLE, DROPPER (43857-0593-1)14 Feb, 2023N/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:

Purpose: for temporary relief of pain and minor inflammation in the mouth or gums following dental procedures.

Product Elements:

Dentox berberis vulgaris, glycyrrhiza glabra, lappa major, stillingia sylvatica, trifolium pratense, phytolacca decandra, lymph node(suis), medulla ossis suis, thymus (suis), thyroidinum (suis), calcarea fluorica, natrum fluoratum, argentum metallicum, aurum metallicum, cuprum metallicum, eugenol, formalinum, lidocaine, mercurius solubilis, molybdenum, niccolum metallicum, palladium metallicum, stannum metallicum, titanium metallicum, zincum metallicum berberis vulgaris root bark berberis vulgaris root bark glycyrrhiza glabra glycyrrhiza glabra arctium lappa root arctium lappa root stillingia sylvatica root stillingia sylvatica root trifolium pratense flower trifolium pratense flower phytolacca americana root phytolacca americana root sus scrofa lymph sus scrofa lymph sus scrofa bone marrow sus scrofa bone marrow sus scrofa thymus sus scrofa thymus thyroid, porcine sus scrofa thyroid calcium fluoride fluoride ion sodium fluoride fluoride ion silver silver gold gold copper copper eugenol eugenol formaldehyde solution formaldehyde solution lidocaine lidocaine mercurius solubilis mercurius solubilis molybdenum molybdenum nickel nickel palladium palladium tin tin titanium titanium zinc zinc water alcohol

Indications and Usage:

Indications: for temporary relief of pain and minor inflammation in the mouth or gums following dental procedures.

Warnings:

Warnings: if pregnant or breast-feeding, ask a health care professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. do not use if tamper evident seal is broken or missing. store in a cool, dry place.

Dosage and Administration:

Directions: 10 drops orally, 3 times a day. consult a physician for use in children under 12 years of age.

Package Label Principal Display Panel:

Package label display: bio active nutritional dentox homeopathic 1 fl oz (30 ml) dentox

Further Questions:

Questions: distributed by: bioactive nutritional, inc. 1803 n. wickham rd. melbourne, fl 32935 bioactivenutritional.com


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.