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NDC 17089-294 Guna-sleep

Avena Sativa Flowering Top - Canakinumab - Chamomile - Helleborus Niger Root - Melatonin - - View Dosage, Usage, Ingredients, Routes, UNII

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

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
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 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.
    Start Marketing Date: [9]
    05-23-2006
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 17089-294?

    The NDC code 17089-294 is assigned by the FDA to the product Guna-sleep which is a human over the counter drug product labeled by Guna Spa. The generic name of Guna-sleep is avena sativa flowering top - canakinumab - chamomile - helleborus niger root - melatonin - melissa officinalis - pulsatilla vulgaris - serotonin - strychnos ignatii seed - sus scrofa pineal gland - valerian -. The product's dosage form is solution/ drops and is administered via oral form. The product is distributed in a single package with assigned NDC code 17089-294-18 1 bottle, dropper in 1 box / 30 ml in 1 bottle, dropper. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Guna-sleep?

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

    What are Guna-sleep Active Ingredients?

    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
    • 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 Guna-sleep UNII Codes?

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

    Which are Guna-sleep Inactive Ingredients 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 Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".