NDC 43857-0094 Apizelen

Alfalfa, Avena Sativa, Chelidonium Majus, Aralia Quinquefolia, Beta Vulgaris, Calendula Officinalis, Cuprum Aceticum, Echinacea, Natrum Muriaticum, Oxalis Acetosella, Paloondo, Phytolacca Decandra, Trifolium Pratense, Urtica Dioica, Viscum Album, Cobalt Aceticum, Cobalt Gluconate, Copper Gluconate, Glutathione, Magnesium Gluconate, Ubiquinone, Ling Chi, Argentum Metallicum, Germanium Metallicum

NDC Product Code 43857-0094

NDC Code: 43857-0094

Proprietary Name: Apizelen 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: Alfalfa, Avena Sativa, Chelidonium Majus, Aralia Quinquefolia, Beta Vulgaris, Calendula Officinalis, Cuprum Aceticum, Echinacea, Natrum Muriaticum, Oxalis Acetosella, Paloondo, Phytolacca Decandra, Trifolium Pratense, Urtica Dioica, Viscum Album, Cobalt Aceticum, Cobalt Gluconate, Copper Gluconate, Glutathione, Magnesium Gluconate, Ubiquinone, Ling Chi, Argentum Metallicum, Germanium 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.


Code Structure
  • 43857 - Bioactive Nutritional, Inc.
    • 43857-0094 - Apizelen

NDC 43857-0094-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Apizelen with NDC 43857-0094 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Apizelen is alfalfa, avena sativa, chelidonium majus, aralia quinquefolia, beta vulgaris, calendula officinalis, cuprum aceticum, echinacea, natrum muriaticum, oxalis acetosella, paloondo, phytolacca decandra, trifolium pratense, urtica dioica, viscum album, cobalt aceticum, cobalt gluconate, copper gluconate, glutathione, magnesium gluconate, ubiquinone, ling chi, argentum metallicum, germanium metallicum. 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.


Apizelen 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.

  • ALFALFA 1 [hp_C]/mL
  • AVENA SATIVA FLOWERING TOP 1 [hp_C]/mL
  • CHELIDONIUM MAJUS 1 [hp_C]/mL
  • AMERICAN GINSENG 2 [hp_C]/mL
  • BETA VULGARIS 2 [hp_C]/mL
  • CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_C]/mL
  • CUPRIC ACETATE 2 [hp_C]/mL
  • ECHINACEA ANGUSTIFOLIA 2 [hp_C]/mL
  • SODIUM CHLORIDE 2 [hp_C]/mL
  • OXALIS ACETOSELLA LEAF 2 [hp_C]/mL
  • LARREA TRIDENTATA TOP 2 [hp_C]/mL
  • PHYTOLACCA AMERICANA ROOT 2 [hp_C]/mL
  • TRIFOLIUM PRATENSE FLOWER 2 [hp_C]/mL
  • URTICA DIOICA 2 [hp_C]/mL
  • VISCUM ALBUM FRUITING TOP 2 [hp_C]/mL
  • COBALTOUS ACETATE 3 [hp_C]/mL
  • COBALTOUS GLUCONATE 3 [hp_C]/mL
  • COPPER GLUCONATE 3 [hp_C]/mL
  • GLUTATHIONE 3 [hp_C]/mL
  • MAGNESIUM GLUCONATE 3 [hp_C]/mL
  • UBIDECARENONE 3 [hp_C]/mL
  • REISHI 4 [hp_C]/mL
  • SILVER 6 [hp_C]/mL
  • GERMANIUM 6 [hp_C]/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.

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: 11-09-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 07-08-2019 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.

Apizelen Product Label Images

Apizelen 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:

Alfalfa 1C, Avena sativa 1C, Chelidonium majus 1C, Aralia quinquefolia 2C, Beta vulgaris 2C, Calendula officinalis 2C, Cuprum aceticum 2C, Echinacea 2C, Natrum muriaticum 2C, Oxalis acetosella 2C, Paloondo 2C, Phytolacca decandra 2C, Trifolium pratense 2C, Urtica dioica 2C, Viscum album 2C, Cobalt aceticum 3C, Cobalt gluconate 3C, Copper gluconate 3C, Gluathione 3C, Magnesium gluconate 3C, Ubiquinone 3C, Ling chi 4C, Argentum metallicum 6C, Germanium metallicum 6C.

Indications:

For temporary relief of fatigue, indigestion, and flatulent colic.

For temporary relief of fatigue, indigestion, and flatulent colic.

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.

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 NUTRITIONALMelbourne, FL 32935For Nutritional Information write:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935

Package Label Display

BioActive HomeopathicAPIZELEN1 FL OZ (30 ml)

* Please review the disclaimer below.

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