Insomnia

Aquilegia Vulgaris, Avena Sativa, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Humulus Lupulus, Hypericum Perforatum, Kali Phosphoricum, Melatonin, Melissa Officinalis, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis

Liddell Laboratories, Inc.
Human Otc Drug
NDC 50845-0108

Insomnia also known as Aquilegia Vulgaris, Avena Sativa, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Humulus Lupulus, Hypericum Perforatum, Kali Phosphoricum, Melatonin, Melissa Officinalis, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis is a human otc drug labeled by 'Liddell Laboratories, Inc.'. National Drug Code (NDC) number for Insomnia is 50845-0108. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Insomnia drug includes Aquilegia Vulgaris - 2 [hp_X]/mL Arabica Coffee Bean - 6 [hp_X]/mL Avena Sativa Flowering Top - 2 [hp_X]/mL Chamomilla - 2 [hp_X]/mL Cypripedium Parviflorum Var. Pubescens Root - 3 [hp_X]/mL Hops - 3 [hp_X]/mL Hypericum Perforatum - 3 [hp_X]/mL Melatonin - 6 [hp_X]/mL Melissa Officinalis - 3 [hp_X]/mL Passiflora Incarnata Flowering Top - 2 [hp_X]/mL and more. The currest status of Insomnia drug is Active.

Drug Information:

Drug NDC:	50845-0108
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Insomnia
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Aquilegia Vulgaris, Avena Sativa, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Humulus Lupulus, Hypericum Perforatum, Kali Phosphoricum, Melatonin, Melissa Officinalis, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Liddell Laboratories, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Spray
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	AQUILEGIA VULGARIS - 2 [hp_X]/mL ARABICA COFFEE BEAN - 6 [hp_X]/mL AVENA SATIVA FLOWERING TOP - 2 [hp_X]/mL CHAMOMILLA - 2 [hp_X]/mL CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - 3 [hp_X]/mL HOPS - 3 [hp_X]/mL HYPERICUM PERFORATUM - 3 [hp_X]/mL MELATONIN - 6 [hp_X]/mL MELISSA OFFICINALIS - 3 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP - 2 [hp_X]/mL Load more... POTASSIUM PHOSPHATE, DIBASIC - 12 [hp_X]/mL SODIUM CHLORIDE - 30 [hp_C]/mL VALERIAN - 2 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	04 Dec, 2012
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 Apr, 2024
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.
Listing Expiration Date:	10 May, 2026
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Liddell Laboratories, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0516536 M0008672
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	8POZ61U1G2 3SW678MX72 MA9CQJ3F7F 21Y9GZ1LZA 01G73H6H83 XK4IUX8MNB JL5DK93RCL YF70189L0N CLF5YFS11O CI71S98N1Z Load more... 451W47IQ8X JWF5YAW3QW
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Seed Storage Proteins [CS] Food Additives [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
50845-0108-2	1 BOTTLE, SPRAY in 1 CARTON (50845-0108-2) / 30 mL in 1 BOTTLE, SPRAY (50845-0108-1)	13 Sep, 2016	10 Apr, 2024	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Insomnia

Aquilegia Vulgaris & more..

Spray
Liddell Laboratories, Inc.
NDC: 50845-0108

Purpose:

Uses: may temporarily relieve symptoms associated with occasional sleeplessness caused by: anxiety restlessness stress caffeine sensitivity** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

Insomnia aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, hypericum perforatum, kali phosphoricum, melatonin, melissa officinalis, natrum muriaticum, passiflora incarnata, valeriana officinalis aquilegia vulgaris aquilegia vulgaris avena sativa flowering top avena sativa flowering top chamomilla chamomilla arabica coffee bean arabica coffee bean cypripedium parviflorum var. pubescens root cypripedium parviflorum var. pubescens root hops hops hypericum perforatum hypericum perforatum potassium phosphate, dibasic phosphate ion melatonin melatonin melissa officinalis melissa officinalis sodium chloride chloride ion passiflora incarnata flowering top passiflora incarnata flowering top valerian valerian water alcohol

Indications and Usage:

Warnings:

Warnings: do not use if you have ever had an allergic reaction to this product or any of its ingredients. stop use and ask a doctor if symptoms persist, worsen, or if new symptoms occur. keep out of reach of children. in case of overdose, get medical help or call a poison control center right away. if pregnant or breast feeding, ask a doctor before using product. do not use if tamper evident seal around neck of bottle is missing or broken. other information: store at room temperature.

Dosage and Administration:

Directions: adults and children over 12: two sprays under the tongue prior to bedtime and when sleep is interrupted by restlessness. children under 12: consult a doctor prior to use.

Package Label Principal Display Panel:

Package label display: oral sprays liddell laboratories est. 1994 32 ins insomnia may relieve symptoms associated with occasional sleeplessness caused by anxiety, restlessness, stress, or caffeine sensitivity. homeopathic doctor formulated readily absorbed. safe. no known side effects. easy to use. 1.0 fl oz (30 ml) insomnia lbl insomnia ctn

Further Questions:

Questions: dist. by: liddell laboratories 201 apple blvd. woodbine, ia 51579 www.liddell.net 1-800-460-7733

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.