69607-0002 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: 69607-0002

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;
  • 2 [hp_X]/mL AVENA SATIVA FLOWERING TOP;
  • 2 [hp_X]/mL MATRICARIA RECUTITA;
  • 6 [hp_X]/mL ARABICA COFFEE BEAN;
  • 3 [hp_X]/mL CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT;
  • 3 [hp_X]/mL HOPS;
  • 6 [hp_X]/mL HYPERICUM PERFORATUM;
  • 12 [hp_X]/mL POTASSIUM PHOSPHATE, DIBASIC;
  • 6 [hp_X]/mL MELATONIN;
  • 3 [hp_X]/mL MELISSA OFFICINALIS;
  • 30 [hp_C]/mL SODIUM CHLORIDE;
  • 2 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP;
  • 2 [hp_X]/mL VALERIAN


Administration Route(s): ORAL

Dosage Form(s): LIQUID

Labeler Information

Labeler Name: Biovea
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:7/2/2015

Package Information

No. Package Code Package Description Billing Unit
169607-0002-130 mL in 1 BOTTLE, DROPPER (69607-0002-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC69607-0002The 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 NAMELIQUIDThe 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 DATE7/2/2015This 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 NAMEBioveaName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAQUILEGIA VULGARIS; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; HOPS; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; MELATONIN; MELISSA OFFICINALIS; SODIUM CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; VALERIANThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH2; 2; 2; 6; 3; 3; 6; 12; 6; 3; 30; 2; 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_C]/mL; [hp_X]/mL; [hp_X]/mL 

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This page was last updated on: 7/3/2020