NDC 43857-0456 Inflammation I

Echinacea (angustifolia), Nasturtium Aquaticum, Phytolacca Decandra, Hydrastis Canadensis, Apis Mellifica, Belladonna, Ferrum Phosphoricum, Nitricum Acidum, Oleander, Silicea

NDC Product Code 43857-0456

NDC CODE: 43857-0456

Proprietary Name: Inflammation I 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: Echinacea (angustifolia), Nasturtium Aquaticum, Phytolacca Decandra, Hydrastis Canadensis, Apis Mellifica, Belladonna, Ferrum Phosphoricum, Nitricum Acidum, Oleander, Silicea 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 43857-0456-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Inflammation I with NDC 43857-0456 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Inflammation I is echinacea (angustifolia), nasturtium aquaticum, phytolacca decandra, hydrastis canadensis, apis mellifica, belladonna, ferrum phosphoricum, nitricum acidum, oleander, silicea. 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.

Inflammation I 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.

  • ECHINACEA ANGUSTIFOLIA 3 [hp_X]/mL
  • NASTURTIUM OFFICINALE 3 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 3 [hp_X]/mL
  • GOLDENSEAL 5 [hp_X]/mL
  • APIS MELLIFERA 12 [hp_X]/mL
  • ATROPA BELLADONNA WHOLE 12 [hp_X]/mL
  • FERROSOFERRIC PHOSPHATE 12 [hp_X]/mL
  • NITRIC ACID 12 [hp_X]/mL
  • NERIUM OLEANDER LEAF 12 [hp_X]/mL
  • SILICON DIOXIDE 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.

  • 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.
  • 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: 07-27-2017 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: 08-23-2022 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 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.

Inflammation I Product Label Images

Inflammation I 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:

Echinacea 3X, Nasturtium Aquaticum 3X, Phytolacca Decandra 3X, Hydrastis Canadensis 3X, Apis Mellifica 12X, Belladonna 12X, Ferrum Phosphoricum 12X, Nitricum Acidum 12X, Oleander 12X, Silicea 12X.

Indications:

For temporary relief of swollen throat, minor throbbing pain deep in the ear; joints swollen and hot; chills and fever with nausea.

For temporary relief of swollen throat, minor throbbing pain deep in the ear; joints swollen and hot; chills and fever with nausea.

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 cool, dry place.WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by physician.

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

Package Label Display:

BIOActive NutritionalINFLAMMATION IHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.