Guna-sleep Solution/ Drops
NDC 17089-294

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 17089-294?
  4. Guna-sleep Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Guna-sleep (avena sativa flowering top - canakinumab - chamomile - helleborus niger root - melatonin - melissa officinalis - pulsatilla vulgaris - serotonin - strychnos ignatii seed - sus scrofa pineal gland - valerian -) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Guna Spa. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a solution/ drops for oral administration. This product entry covers the primary NDC 17089-294 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
17089-294
Proprietary Name:
Guna-sleep
Non-Proprietary Name: [1]
Avena Sativa Flowering Top - Canakinumab - Chamomile - Helleborus Niger Root - Melatonin - Melissa Officinalis - Pulsatilla Vulgaris - Serotonin - Strychnos Ignatii Seed - Sus Scrofa Pineal Gland - Valerian -
Substance Name: [2]
Avena Sativa Flowering Top; Canakinumab; Chamomile; Helleborus Niger Root; Melatonin; Melissa Officinalis; Pulsatilla Vulgaris; Serotonin; Strychnos Ignatii Seed; Sus Scrofa Pineal Gland; Valerian
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:
62c57cc4-28c9-406f-821d-1d48370968f2
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
05-23-2006
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 17089-294?

The NDC code 17089-294 is assigned by the FDA to the product Guna-sleep. It is commonly known by its generic name, avena sativa flowering top - canakinumab - chamomile - helleborus niger root - melatonin - melissa officinalis - pulsatilla vulgaris - serotonin - strychnos ignatii seed - sus scrofa pineal gland - valerian -. 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: 17089-294-18. 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?

This product is used as For the temporary relief of difficulty falling asleep

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.
  • AVENA SATIVA FLOWERING TOP 6 [hp_C]/30mL
  • CANAKINUMAB 4 [hp_C]/30mL - a human anti-interleukin-1beta monoclonal antibody for treatment of cryopyrin-associated periodic syndrome
  • CHAMOMILE 6 [hp_C]/30mL - Common name for several daisy-like plants (MATRICARIA; TRIPLEUROSPERMUM; ANTHEMIS; CHAMAEMELUM) native to Europe and Western Asia, now naturalized in the United States and Australia.
  • HELLEBORUS NIGER ROOT 6 [hp_C]/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.
  • MELISSA OFFICINALIS 6 [hp_C]/30mL - A plant genus of the family LAMIACEAE. The common names of beebalm or lemonbalm are also used for MONARDA.
  • PULSATILLA VULGARIS 6 [hp_C]/30mL
  • SEROTONIN 6 [hp_C]/30mL - A biochemical messenger and regulator, synthesized from the essential amino acid L-TRYPTOPHAN. In humans it is found primarily in the central nervous system, gastrointestinal tract, and blood platelets. Serotonin mediates several important physiological functions including neurotransmission, gastrointestinal motility, hemostasis, and cardiovascular integrity. Multiple receptor families (RECEPTORS, SEROTONIN) explain the broad physiological actions and distribution of this biochemical mediator.
  • STRYCHNOS IGNATII SEED 6 [hp_C]/30mL
  • SUS SCROFA PINEAL GLAND 12 [hp_X]/30mL
  • VALERIAN 6 [hp_C]/30mL - A plant genus of the family VALERIANACEAE, order Dipsacales, subclass Asteridae, class Magnoliopsida. It is best known for the sedative use and valepotriate content of the roots. It is sometimes called Garden Heliotrope but is unrelated to true Heliotrope (HELIOTROPIUM).

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:

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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".