NDC 43857-0039 Dentox

Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Lymph Node(suis), Medulla Ossis Suis, Thymus (suis), Thyroidinum (suis),

NDC Product Code 43857-0039

NDC Code: 43857-0039

Proprietary Name: Dentox What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Lymph Node(suis), Medulla Ossis Suis, Thymus (suis), Thyroidinum (suis), 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.

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.
    • 43857-0039 - Dentox

NDC 43857-0039-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Dentox with NDC 43857-0039 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Dentox is berberis vulgaris, glycyrrhiza glabra, lappa major, phytolacca decandra, stillingia sylvatica, trifolium pratense, lymph node(suis), medulla ossis suis, thymus (suis), thyroidinum (suis),. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug 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.

Dentox Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL
  • GLYCYRRHIZA GLABRA 3 [hp_X]/mL
  • ARCTIUM LAPPA ROOT 3 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 3 [hp_X]/mL
  • STILLINGIA SYLVATICA ROOT 3 [hp_X]/mL
  • TRIFOLIUM PRATENSE FLOWER 3 [hp_X]/mL
  • SUS SCROFA LYMPH 8 [hp_X]/mL
  • SUS SCROFA BONE MARROW 8 [hp_X]/mL
  • SUS SCROFA THYMUS 8 [hp_X]/mL
  • THYROID, PORCINE 8 [hp_X]/mL
  • CALCIUM FLUORIDE 12 [hp_X]/mL
  • SODIUM FLUORIDE 12 [hp_X]/mL
  • SILVER 12 [hp_X]/mL
  • GOLD 12 [hp_X]/mL
  • COPPER 12 [hp_X]/mL
  • EUGENOL 12 [hp_X]/mL
  • FORMALDEHYDE 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
  • TIN 12 [hp_X]/mL
  • TITANIUM 12 [hp_X]/mL
  • ZINC 12 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bioactive Nutritional, Inc.
Labeler Code: 43857
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 06-05-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dentox Product Label Images

Dentox Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Phytolacca Decandra 3X, Stillingia Sylvatica 3X, Trifolium Pratense 3X, Lymph (Suis) 8X, Medulla Ossis Suis 8X, Thymus (Suis) 8X, Thyroidinum (Suis) 8X, Calcarea Fluorica 12X, Natrum Fluoratum 12X, Argentum Metallicum 12X, 30X, 60X, 200X, Aurum Metallicum 12X, 30X, 60X, 200X, Cuprum Metallicum 12X, 30X, 60X, 200X, Eugenol 12X, 30X, 60X, 200X, Formalinum 12X, 30X, 60X, 200X, Lidocaine 12X, 30X, 60X, 200X, Mercurius Solubilis 12X, 30X, 60X, 200X, Molybdenum Metallicum 12X, 30X, 60X, 200X, Niccolum Metallicum 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X, Stannum Metallicum 12X, 30X, 60X, 200X, Titanium Metallicum 12X, 30X, 60X, 200X, Zincum Metallicum 12X, 30X, 60X, 200X.

Indications:

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

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

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.

Directions:

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

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com*For a complete list of Dental Isodes contact BioActive Nutritional, Inc.

Package Label Display:

BIOActive NutritionalDENTOXHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.

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