55714-4787 NDC - RESTLESS LEG (MYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB., MAG. CARB., MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA,PASSIFLORA)

Drug Information

  • Product NDC: 55714-4787
  • Proprietary Name: Restless Leg
  • Non Proprietary Name: Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb., Mag. carb., Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla,Passiflora
  • Active Ingredient(s): 15 [hp_X]/mL AMANITA MUSCARIA FRUITING BODY; 16 [hp_X]/mL AVICULARIA AVICULARIA; 15 [hp_X]/mL CAUSTICUM; 15 [hp_X]/mL CINCHONA OFFICINALIS BARK; 15 [hp_X]/mL CLAVICEPS PURPUREA SCLEROTIUM; 15 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP; 15 [hp_X]/mL COPPER; 15 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT; 15 [hp_X]/mL HYOSCYAMUS NIGER; 15 [hp_X]/mL HYPERICUM PERFORATUM; 15 [hp_X]/mL LEAD; 15 [hp_X]/mL LYCOSA TARANTULA; 15 [hp_X]/mL MAGNESIUM CARBONATE; 6 [hp_X]/mL MATRICARIA CHAMOMILLA; 15 [hp_X]/mL MERCURY; 6 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP; 15 [hp_X]/mL POTASSIUM CARBONATE; 15 [hp_X]/mL STRYCHNINE; 15 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED; 15 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF; 15 [hp_X]/mL VALERIAN; 15 [hp_X]/mL VERBASCUM THAPSUS; 15 [hp_X]/mL ZINC
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Copper [CS]; Copper-containing Intrauterine Device [EPC]; Decreased Embryonic Implantation [PE]; Decreased Sperm Motility [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Inhibit Ovum Fertilization [PE]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Seed Storage Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: Newton Laboratories, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:9/2/2019

Package Information

No. Package Code Package Description Billing Unit
155714-4787-130 mL in 1 BOTTLE, GLASS (55714-4787-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55714-4787The 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 NAMERestless LegThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEMygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb., Mag. carb., Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla,PassifloraThe 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 DATE9/2/2019This 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 NAMENewton Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAMANITA MUSCARIA FRUITING BODY; AVICULARIA AVICULARIA; CAUSTICUM; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; LEAD; LYCOSA TARANTULA; MAGNESIUM CARBONATE; MATRICARIA CHAMOMILLA; MERCURY; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERBASCUM THAPSUS; ZINCAn 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 STRENGTH15; 16; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 6; 15; 15; 15; 15; 15; 15; 15 
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_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_X]/mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS] 

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This page was last updated on: 12/19/2025

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