Guna-cell Solution/ Drops
NDC 17089-450

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 17089-450?
  4. Guna-cell Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Guna-cell (acetylcarnitine, l-ampc-alpha-lipoic ac-a-tocopherol-ascorbic acid-calc carb-citric ac-cobalamin-colchicum-conium-cupric sulf-herring sperm dna-ferrous fumarate-folic acid-fumaric acid-kali aspartate-mang phos-mang gluconate-mang phos ii-pyruvaldehyde-nat oxalaceticum-sodium pyruvate-niacin-pantothenic acid-ph-podophyllum peltatum-pyridoxine hydrochloride-riboflavin-saccharomyces cerevisiae rna-selenomethionine-succinic acid-sulfur-thiamine hydrochloride-zinc) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Guna Spa. This medication is typically used as a acidifying activity [moa]. It is supplied as a solution/ drops for oral administration. This product entry covers the primary NDC 17089-450 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
17089-450
Proprietary Name:
Guna-cell
Non-Proprietary Name: [1]
Acetylcarnitine, L-ampc-alpha-lipoic Ac-a-tocopherol-ascorbic Acid-calc Carb-citric Ac-cobalamin-colchicum-conium-cupric Sulf-herring Sperm Dna-ferrous Fumarate-folic Acid-fumaric Acid-kali Aspartate-mang Phos-mang Gluconate-mang Phos Ii-pyruvaldehyde-nat Oxalaceticum-sodium Pyruvate-niacin-pantothenic Acid-ph-podophyllum Peltatum-pyridoxine Hydrochloride-riboflavin-saccharomyces Cerevisiae Rna-selenomethionine-succinic Acid-sulfur-thiamine Hydrochloride-zinc
Substance Name: [2]
.alpha.-lipoic Acid; .alpha.-tocopherol Acetate, Dl-; Acetylcarnitine; Adenosine Cyclic Phosphate; Ascorbic Acid; Calcium Carbonate; Citric Acid Monohydrate; Cobalamin; Colchicum Autumnale Bulb; Conium Maculatum Flowering Top; Cupric Sulfate; Ferrous Fumarate; Folic Acid; Fumaric Acid; Herring Sperm Dna; Magnesium Phosphate, Tribasic, Pentahydrate; Manganese Gluconate; Manganese Phosphate, Dibasic; Niacin; Pantothenic Acid; Phosphorus; Podophyllum Peltatum Root; Potassium Aspartate; Pyridoxine Hydrochloride; Pyruvaldehyde; Riboflavin; Saccharomyces Cerevisiae Rna; Selenomethionine; Sodium Diethyl Oxalacetate; Sodium Pyruvate; Succinic Acid; Sulfur; Thiamine Hydrochloride; 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:
90db80ed-c037-4e8f-a7f6-304a65f9fe22
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
05-27-2010
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 17089-450?

The NDC code 17089-450 is assigned by the FDA to the product Guna-cell. It is commonly known by its generic name, acetylcarnitine, l-ampc-alpha-lipoic ac-a-tocopherol-ascorbic acid-calc carb-citric ac-cobalamin-colchicum-conium-cupric sulf-herring sperm dna-ferrous fumarate-folic acid-fumaric acid-kali aspartate-mang phos-mang gluconate-mang phos ii-pyruvaldehyde-nat oxalaceticum-sodium pyruvate-niacin-pantothenic acid-ph-podophyllum peltatum-pyridoxine hydrochloride-riboflavin-saccharomyces cerevisiae rna-selenomethionine-succinic acid-sulfur-thiamine hydrochloride-zinc. 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: 17089-450-18. 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.
  • .ALPHA.-LIPOIC ACID 3 [hp_X]/30mL - An octanoic acid bridged with two sulfurs so that it is sometimes also called a pentanoic acid in some naming schemes. It is biosynthesized by cleavage of LINOLEIC ACID and is a coenzyme of oxoglutarate dehydrogenase (KETOGLUTARATE DEHYDROGENASE COMPLEX). It is used in DIETARY SUPPLEMENTS.
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 3 [hp_X]/30mL
  • ACETYLCARNITINE 3 [hp_X]/30mL - An acetic acid ester of CARNITINE that facilitates movement of ACETYL COA into the matrices of mammalian MITOCHONDRIA during the oxidation of FATTY ACIDS.
  • ADENOSINE CYCLIC PHOSPHATE 6 [hp_X]/30mL
  • ASCORBIC ACID 3 [hp_X]/30mL - A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
  • 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.
  • CITRIC ACID MONOHYDRATE 3 [hp_X]/30mL - A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.
  • COBALAMIN 3 [hp_X]/30mL
  • COLCHICUM AUTUMNALE BULB 6 [hp_X]/30mL
  • CONIUM MACULATUM FLOWERING TOP 6 [hp_X]/30mL
  • CUPRIC SULFATE 3 [hp_X]/30mL
  • FERROUS FUMARATE 3 [hp_X]/30mL - used in treatment of iron deficiency anemia; RN given refers to Fe(+2)[1:1] salt
  • 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.
  • FUMARIC ACID 3 [hp_X]/30mL - see also record for ferrous fumarate; use FUMARATES for general fumaric acid esters
  • HERRING SPERM DNA 6 [hp_X]/30mL
  • MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE 3 [hp_X]/30mL
  • MANGANESE GLUCONATE 3 [hp_X]/30mL
  • MANGANESE PHOSPHATE, DIBASIC 6 [hp_X]/30mL
  • NIACIN 3 [hp_X]/30mL - A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has PELLAGRA-curative, vasodilating, and antilipemic properties.
  • PANTOTHENIC ACID 3 [hp_X]/30mL - A butyryl-beta-alanine that can also be viewed as pantoic acid complexed with BETA ALANINE. It is incorporated into COENZYME A and protects cells against peroxidative damage by increasing the level of GLUTATHIONE.
  • PHOSPHORUS 4 [hp_X]/30mL - A non-metal element that has the atomic symbol P, atomic number 15, and atomic weight 31. It is an essential element that takes part in a broad variety of biochemical reactions.
  • PODOPHYLLUM PELTATUM ROOT 6 [hp_X]/30mL
  • POTASSIUM ASPARTATE 3 [hp_X]/30mL - One of the non-essential amino acids commonly occurring in the L-form. It is found in animals and plants, especially in sugar cane and sugar beets. It may be a neurotransmitter.
  • PYRIDOXINE HYDROCHLORIDE 6 [hp_X]/30mL - The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).
  • PYRUVALDEHYDE 10 [hp_X]/30mL - An organic compound used often as a reagent in organic synthesis, as a flavoring agent, and in tanning. It has been demonstrated as an intermediate in the metabolism of acetone and its derivatives in isolated cell preparations, in various culture media, and in vivo in certain animals.
  • RIBOFLAVIN 6 [hp_X]/30mL - Nutritional factor found in milk, eggs, malted barley, liver, kidney, heart, and leafy vegetables. The richest natural source is yeast. It occurs in the free form only in the retina of the eye, in whey, and in urine; its principal forms in tissues and cells are as FLAVIN MONONUCLEOTIDE and FLAVIN-ADENINE DINUCLEOTIDE.
  • SACCHAROMYCES CEREVISIAE RNA 6 [hp_X]/30mL
  • SELENOMETHIONINE 3 [hp_X]/30mL - Diagnostic aid in pancreas function determination.
  • SODIUM DIETHYL OXALACETATE 3 [hp_X]/30mL
  • SODIUM PYRUVATE 3 [hp_X]/30mL
  • SUCCINIC ACID 3 [hp_X]/30mL - A water-soluble, colorless crystal with an acid taste that is used as a chemical intermediate, in medicine, the manufacture of lacquers, and to make perfume esters. It is also used in foods as a sequestrant, buffer, and a neutralizing agent. (Hawley's Condensed Chemical Dictionary, 12th ed, p1099; McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed, p1851)
  • SULFUR 3 [hp_X]/30mL - An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine.
  • THIAMINE HYDROCHLORIDE 4 [hp_X]/30mL
  • 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.

* Please review the full disclaimer at the bottom of this page.

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".