NDC 43857-0515 Oligo Bio Iodine

Chelidonium Majus, Spongia Tosta, Iodium, Lycopus Virginicus, Ginkgo Biloba, Pinus Sylvestris, Fucus Vesiculosus, Germanium Sesquioxide, Hypophysis Suis, Thyroidinum (suis), Cysteinum, Manganese Gluconate, Alpha-ketoglutaricum Acidum, Calcarea Carbonica, Ferrum Iodatum, Fumaricum Acidum, Kali Iodatum, Natrum Oxalaceticum, Pulsatilla (vulgaris), Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum Metallicum, Niccolum Metallicum,

NDC Product Code 43857-0515

NDC CODE: 43857-0515

Proprietary Name: Oligo Bio Iodine 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: Chelidonium Majus, Spongia Tosta, Iodium, Lycopus Virginicus, Ginkgo Biloba, Pinus Sylvestris, Fucus Vesiculosus, Germanium Sesquioxide, Hypophysis Suis, Thyroidinum (suis), Cysteinum, Manganese Gluconate, Alpha-ketoglutaricum Acidum, Calcarea Carbonica, Ferrum Iodatum, Fumaricum Acidum, Kali Iodatum, Natrum Oxalaceticum, Pulsatilla (vulgaris), Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum Metallicum, Niccolum Metallicum, 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.

NDC 43857-0515-1

Package Description: 60 mL in 1 BOTTLE, DROPPER

NDC Product Information

Oligo Bio Iodine with NDC 43857-0515 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Oligo Bio Iodine is chelidonium majus, spongia tosta, iodium, lycopus virginicus, ginkgo biloba, pinus sylvestris, fucus vesiculosus, germanium sesquioxide, hypophysis suis, thyroidinum (suis), cysteinum, manganese gluconate, alpha-ketoglutaricum acidum, calcarea carbonica, ferrum iodatum, fumaricum acidum, kali iodatum, natrum oxalaceticum, pulsatilla (vulgaris), argentum metallicum, aurum metallicum, cuprum metallicum, eugenol, formalinum, lidocaine, mercurius solubilis, molybdenum metallicum, niccolum metallicum, . The product's dosage form is liquid and is administered via oral form.

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.

Oligo Bio Iodine 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.


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.

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

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Allergens - [CS]
  • Allergens - [CS]
  • Allergens - [CS]
  • Allergens - [CS]
  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amides - [CS]
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Copper - [CS]
  • Copper-containing Intrauterine Device - [EPC] (Established Pharmacologic Class)
  • Decreased Embryonic Implantation - [PE] (Physiologic Effect)
  • Decreased Sperm Motility - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Inhibit Ovum Fertilization - [PE] (Physiologic Effect)
  • Local Anesthesia - [PE] (Physiologic Effect)
  • Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action)
  • Paramagnetic Contrast Agent - [EPC] (Established Pharmacologic Class)
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
  • Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)

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: 06-27-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 11-06-2024 What is the End Marketing Date?
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.

Exclude Flag: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Oligo Bio Iodine 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:

Chelidonium Majus 3X, Spongia Tosta 3X, Iodium 4X, 6X, 12X, Lycopus Virginicus 4X, 6X, 12X, 30X, 200X, Ginkgo Biloba 6X, Pinus Sylvestris 6X, Fucus Vesiculosus 6X, 12X, 30X, Germanium Sesquioxide 8X, Hypophysis Suis 8X, 12X, 100X, 200X, Thyroidinum (Suis) 8X, 12X, 100X, 200X, Cysteinum 9X, Manganese Gluconate 10X, alpha-Ketoglutaricum Acidum 12X, Calcarea Carbonica 12X, Ferrum Iodatum 12X, Fumaricum Acidum 12X, Kali Iodatum 12X, Natrum Oxalaceticum 12X, Pulsatilla 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, Mumps 30X, 200X, Rubella 12X, 30X, 200X, Coxsackie A2 33C, 60C, 400C, Coxsackie A7 33C, 60C, 400C, Coxsackie B1 33C, 60C, 400C, Coxsackie B3 33C, 60C, 400C, Coxsackie B4 33C, 60C, 400C.

Indications:

For temporary relief of fatigue, muscular weakness, weak pulse, tendency to faint, cold hands & feet, low blood pressure, nervous tremor of limbs & sensitive to cold.

For temporary relief of fatigue, muscular weakness, weak pulse, tendency to faint, cold hands & feet, low blood pressure, nervous tremor of limbs & sensitive to cold.

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.

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.

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

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 NutritionalOLIGO BIO IODINEHOMEOPATHIC2 FL OZ (60 ml)

* Please review the disclaimer below.