NDC 44911-0360 Organdrainex

Allium Cepa, Allium Sativum, Aloe, Ambrosia Artemisiaefolia, Berberis Vulgaris, Chelidonium Majus, Collinsonia Canadensis, Cynara Scolymus, Methylcobalamin, Petroselinum Sativum, Trifolium Pratense, Alpha-lipoicum Acidum, Palladium Metallicum

NDC Product Code 44911-0360

NDC Code: 44911-0360

Proprietary Name: Organdrainex 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: Allium Cepa, Allium Sativum, Aloe, Ambrosia Artemisiaefolia, Berberis Vulgaris, Chelidonium Majus, Collinsonia Canadensis, Cynara Scolymus, Methylcobalamin, Petroselinum Sativum, Trifolium Pratense, Alpha-lipoicum Acidum, Palladium 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

  • 44911 - Energique, Inc.
    • 44911-0360 - Organdrainex

NDC 44911-0360-1

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Organdrainex with NDC 44911-0360 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Organdrainex is allium cepa, allium sativum, aloe, ambrosia artemisiaefolia, berberis vulgaris, chelidonium majus, collinsonia canadensis, cynara scolymus, methylcobalamin, petroselinum sativum, trifolium pratense, alpha-lipoicum acidum, palladium metallicum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Energique, 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.

Organdrainex 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.

  • ONION 3 [hp_X]/mL
  • ALLIUM SATIVUM WHOLE 3 [hp_X]/mL
  • ALOE 3 [hp_X]/mL
  • AMBROSIA ARTEMISIIFOLIA 3 [hp_X]/mL
  • BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL
  • CHELIDONIUM MAJUS 3 [hp_X]/mL
  • COLLINSONIA CANADENSIS ROOT 3 [hp_X]/mL
  • CYNARA SCOLYMUS LEAF 3 [hp_X]/mL
  • METHYLCOBALAMIN 3 [hp_X]/mL
  • PETROSELINUM CRISPUM 3 [hp_X]/mL
  • TRIFOLIUM PRATENSE FLOWER 3 [hp_X]/mL
  • THIOCTIC ACID 12 [hp_X]/mL
  • PALLADIUM 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • 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: Energique, Inc.
Labeler Code: 44911
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: 06-14-2016 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: 08-02-2021 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.

Organdrainex Product Label Images

Organdrainex 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:

Allium Cepa 3X, 6X, 12X, 30X, 60X, 200X, Allium Sativum 3X, 6X, 12X, 30X, 60X, 200X, Aloe 3X, 6X, 12X, 30X, 60X, 200X, Ambrosia Artemisiaefolia 3X, 6X, 12X, 30X, 60X, 200X, Berberis Vulgaris 3X, 6X, 12X, 30X, 60X, 200X, Chelidonium Majus 3X, 6X, 12X, 30X, 60X, 200X, Collinsonia Canadensis 3X, 6X, 12X, 30X, 60X, 200X, Cynara Scolymus 3X, 6X, 12X, 30X, 60X, 200X, Methylcobalamin 3X, 6X, 12X, 30X, 60X, 200X, Petroselinum Sativum 3X, 6X, 12X, 30X, 60X, 200X, Trifolium Pratense 3X, 6X, 12X, 30X, 60X, 200X, Alpha-Lipoicum Acidum 12X, 30X, 60X, 200X, Palladium Metallicum 12X, 30X, 60X, 200X.

Indications:

Lymphatic Drainage.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Lymphatic Drainage.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

If pregnant or breastfeeding, ask a health 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:

Adults, 1 teaspoon twice daily.  Children, 2-9 years, 1/2 teaspoon twice daily, or as directed by a physician.  Take between meals without food.Consult a physician for use in children under 6 years of age.

Inactive Ingredients:

Citric Acid, Demineralized Water, Potassium Sorbate

Questions:

Dist. by Energique, Inc.201 Apple Blvd.Woodbine, IA 51579    800.868.8078

Package Label Display:

ENERGIQUESINCE 1987HOMEOPATHIC REMEDYORGANDRAINEX4 fl. oz. (118 ml)

* Please review the disclaimer below.

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