50845-0272 NDC - 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)

Drug Information

  • Product NDC: 50845-0272
  • Proprietary Name: Insomnia
  • 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
  • Active Ingredient(s): 2 [hp_X]/mL AQUILEGIA VULGARIS; 6 [hp_X]/mL ARABICA COFFEE BEAN; 2 [hp_X]/mL AVENA SATIVA FLOWERING TOP; 8 [hp_X]/mL CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; 12 [hp_X]/mL DIBASIC POTASSIUM PHOSPHATE; 3 [hp_X]/mL HOPS; 6 [hp_X]/mL HYPERICUM PERFORATUM WHOLE; 2 [hp_X]/mL MATRICARIA CHAMOMILLA WHOLE; 6 [hp_X]/mL MELATONIN; 3 [hp_X]/mL MELISSA OFFICINALIS WHOLE; 2 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP; 30 [hp_C]/mL SODIUM CHLORIDE; 2 [hp_X]/mL VALERIAN
  • Administration Route(s): ORAL
  • Dosage Form(s): SPRAY
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Seed Storage Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: Liddell Laboratories, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:12/23/2020

Package Information

No. Package Code Package Description Billing Unit
150845-0272-21 BOTTLE, SPRAY in 1 CARTON (50845-0272-2) / 30 mL in 1 BOTTLE, SPRAY (50845-0272-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC50845-0272The 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.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEInsomniaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAquilegia Vulgaris, Avena Sativa, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Humulus Lupulus, Hypericum Perforatum, Kali Phosphoricum, Melatonin, Melissa Officinalis, Natrum Muriaticum, Passiflora Incarnata, Valeriana OfficinalisThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAYThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/23/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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.
LABELER NAMELiddell Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAQUILEGIA VULGARIS; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DIBASIC POTASSIUM PHOSPHATE; HOPS; HYPERICUM PERFORATUM WHOLE; MATRICARIA CHAMOMILLA WHOLE; MELATONIN; MELISSA OFFICINALIS WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; SODIUM CHLORIDE; VALERIANAn 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.
ACTIVE NUMERATOR STRENGTH2; 6; 2; 8; 12; 3; 6; 2; 6; 3; 2; 30; 2 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS] 

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This page was last updated on: 7/4/2025

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