Guna-awareness Solution/ Drops
NDC 17089-350

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 17089-350?
  4. Guna-awareness Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Guna-awareness (betaine - bufo bufo cutaneous gland - calcium carbonate - chromic sulfate - cicuta virosa root - copper - folic acid - gold - cobalamin - iron - lachesis muta venom - melatonin - molybdenum - neurotrophin-3 - neurotrophin-4 - oxytocin - silicon dioxide - sus scrofa frontal lobe - sus scrofa temporal lobe - thyrotropin alfa - ubidecarenone - vanadium - zinc - brain-derived neurotrophic factor human -) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Guna Spa. This medication is typically used as a allergens [cs]. It is supplied as a solution/ drops for oral administration. This product entry covers the primary NDC 17089-350 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
17089-350
Proprietary Name:
Guna-awareness
Non-Proprietary Name: [1]
Betaine - Bufo Bufo Cutaneous Gland - Calcium Carbonate - Chromic Sulfate - Cicuta Virosa Root - Copper - Folic Acid - Gold - Cobalamin - Iron - Lachesis Muta Venom - Melatonin - Molybdenum - Neurotrophin-3 - Neurotrophin-4 - Oxytocin - Silicon Dioxide - Sus Scrofa Frontal Lobe - Sus Scrofa Temporal Lobe - Thyrotropin Alfa - Ubidecarenone - Vanadium - Zinc - Brain-derived Neurotrophic Factor Human -
Substance Name: [2]
Betaine; Brain-derived Neurotrophic Factor Human; Bufo Bufo Cutaneous Gland; Calcium Carbonate; Chromic Sulfate; Cicuta Virosa Root; Cobalamin; Copper; Folic Acid; Gold; Iron; Lachesis Muta Venom; Melatonin; Molybdenum; Neurotrophin-3; Neurotrophin-4; Oxytocin; Silicon Dioxide; Sus Scrofa Frontal Lobe; Sus Scrofa Temporal Lobe; Thyrotropin Alfa; Ubidecarenone; Vanadium; Zinc
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Guna Spa
Labeler Code:
17089
Product Label ID:
10e46b39-7903-4390-b72d-865291245b4c
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
04-16-2008
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 17089-350?

The NDC code 17089-350 is assigned by the FDA to the product Guna-awareness. It is commonly known by its generic name, betaine - bufo bufo cutaneous gland - calcium carbonate - chromic sulfate - cicuta virosa root - copper - folic acid - gold - cobalamin - iron - lachesis muta venom - melatonin - molybdenum - neurotrophin-3 - neurotrophin-4 - oxytocin - silicon dioxide - sus scrofa frontal lobe - sus scrofa temporal lobe - thyrotropin alfa - ubidecarenone - vanadium - zinc - brain-derived neurotrophic factor human -. This pharmaceutical product is labeled by Guna Spa and is currently categorized as listed product. The medication is a solution/ drops administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 17089-350-18. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Take 15 minutes before mealsAdults and children 12 years and older    20 drops in a little water, 2 times per dayChildren  between 12 years and 6 years of age    10 drops in a little water, 2 times per dayChildren under 6 years     5 drops in a glass of water, 2 times per day

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • BETAINE 3 [hp_X]/30mL - A naturally occurring compound that has been of interest for its role in osmoregulation. As a drug, betaine hydrochloride has been used as a source of hydrochloric acid in the treatment of hypochlorhydria. Betaine has also been used in the treatment of liver disorders, for hyperkalemia, for homocystinuria, and for gastrointestinal disturbances. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1341)
  • BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN 4 [hp_C]/30mL
  • BUFO BUFO CUTANEOUS GLAND 12 [hp_X]/30mL
  • CALCIUM CARBONATE 3 [hp_X]/30mL - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
  • CHROMIC SULFATE 3 [hp_X]/30mL
  • CICUTA VIROSA ROOT 12 [hp_X]/30mL
  • COBALAMIN 3 [hp_X]/30mL
  • COPPER 12 [hp_X]/30mL - A heavy metal trace element with the atomic symbol Cu, atomic number 29, and atomic weight 63.55.
  • FOLIC ACID 3 [hp_X]/30mL - A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.
  • GOLD 12 [hp_X]/30mL - A yellow metallic element with the atomic symbol Au, atomic number 79, and atomic weight 197. It is used in jewelry, goldplating of other metals, as currency, and in dental restoration. Many of its clinical applications, such as ANTIRHEUMATIC AGENTS, are in the form of its salts.
  • IRON 3 [hp_X]/30mL - A metallic element with atomic symbol Fe, atomic number 26, and atomic weight 55.85. It is an essential constituent of HEMOGLOBINS; CYTOCHROMES; and IRON-BINDING PROTEINS. It plays a role in cellular redox reactions and in the transport of OXYGEN.
  • LACHESIS MUTA VENOM 12 [hp_X]/30mL
  • MELATONIN 4 [hp_C]/30mL - A biogenic amine that is found in animals and plants. In mammals, melatonin is produced by the PINEAL GLAND. Its secretion increases in darkness and decreases during exposure to light. Melatonin is implicated in the regulation of SLEEP, mood, and REPRODUCTION. Melatonin is also an effective antioxidant.
  • MOLYBDENUM 3 [hp_X]/30mL - A metallic element with the atomic symbol Mo, atomic number 42, and atomic weight 95.95. It is an essential trace element, being a component of the enzymes xanthine oxidase, aldehyde oxidase, and nitrate reductase.
  • NEUROTROPHIN-3 4 [hp_C]/30mL - A neurotrophic factor involved in regulating the survival of visceral and proprioceptive sensory neurons. It is closely homologous to nerve growth factor beta and BRAIN-DERIVED NEUROTROPHIC FACTOR.
  • NEUROTROPHIN-4 4 [hp_C]/30mL - amino acid sequence given in first source; isolated from human and rat; homologous to Xenopus and viper NT-4; RN given refers to human NT-4
  • OXYTOCIN 6 [hp_X]/30mL - A nonapeptide hormone released from the neurohypophysis (PITUITARY GLAND, POSTERIOR). It differs from VASOPRESSIN by two amino acids at residues 3 and 8. Oxytocin acts on SMOOTH MUSCLE CELLS, such as causing UTERINE CONTRACTIONS and MILK EJECTION.
  • SILICON DIOXIDE 12 [hp_X]/30mL - Transparent, tasteless crystals found in nature as agate, amethyst, chalcedony, cristobalite, flint, sand, QUARTZ, and tridymite. The compound is insoluble in water or acids except hydrofluoric acid.
  • SUS SCROFA FRONTAL LOBE 6 [hp_X]/30mL
  • SUS SCROFA TEMPORAL LOBE 6 [hp_X]/30mL
  • THYROTROPIN ALFA 3 [hp_X]/30mL - A highly purified recombinant glycoprotein form of human THYROID-STIMULATING HORMONE, produced by recombinant DNA technology comprising two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites, and a beta subunit of 118 residues containing one N-linked glycosylation site. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary thyroid stimulating hormone.
  • UBIDECARENONE 3 [hp_X]/30mL
  • VANADIUM 6 [hp_X]/30mL - A metallic element with the atomic symbol V, atomic number 23, and atomic weight 50.94. It is used in the manufacture of vanadium steel. Prolonged exposure can lead to chronic intoxication caused by absorption usually via the lungs.
  • ZINC 3 [hp_X]/30mL - A metallic element of atomic number 30 and atomic weight 65.38. It is a necessary trace element in the diet, forming an essential part of many enzymes, and playing an important role in protein synthesis and in cell division. Zinc deficiency is associated with ANEMIA, short stature, HYPOGONADISM, impaired WOUND HEALING, and geophagia. It is known by the symbol Zn.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".