NDC 55714-4612

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

Restless Leg is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Newton Laboratories, Inc.. The primary component is Avicularia Avicularia; Amanita Muscaria Var. Muscaria Fruiting Body; Causticum; Cinchona Officinalis Bark; Conium Maculatum Flowering Top; Copper; Gelsemium Sempervirens Root; Hyoscyamus Niger; Hypericum Perforatum; Potassium Carbonate; Magnesium Carbonate; Mercury; Strychnos Nux-vomica Seed; Lead; Toxicodendron Pubescens Leaf; Claviceps Purpurea Sclerotium; Strychnine; Lycosa Tarantula; Valerian; Verbascum Thapsus; Zinc; Matricaria Recutita; Passiflora Incarnata Flowering Top.

• Product ID: 55714-4612_d062da5b-fd1c-a3a2-56b1-bad8a3c5838b
• NDC: 55714-4612
• Product Type: Human Prescription Drug
• Proprietary Name: Restless Leg
• Generic 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
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2011-06-01
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: Newton Laboratories, Inc.
• Substance Name: AVICULARIA AVICULARIA; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; MERCURY; STRYCHNOS NUX-VOMICA SEED; LEAD; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; STRYCHNINE; LYCOSA TARANTULA; VALERIAN; VERBASCUM THAPSUS; ZINC; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP
• Active Ingredient Strength: 15 [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 Classes: Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55714-4612-2

59.14 mL in 1 BOTTLE, GLASS (55714-4612-2)

• Marketing Start Date: 2011-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55714-4612-2 [55714461202]

Restless Leg LIQUID

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-02-10
• Inactivation Date: 2020-01-31

NDC 55714-4612-1 [55714461201]

Restless Leg LIQUID

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-06-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
AVICULARIA AVICULARIA	15 [hp_X]/mL

OpenFDA Data

• SPL SET ID: d3f2d68b-9b8f-1529-93c9-8335198ea5a9
• Manufacturer:
  • Newton Laboratories, Inc.
• UNII:
  • JWF5YAW3QW
  • 6IO182RP7A
  • C9TD27U172
  • 639KR60Q1Q
  • BQN1B9B9HA
  • XK4IUX8MNB
  • 0E53J927NA
  • FXS1BY2PGL
  • J41CSQ7QDS
  • 8ZTK6T93B6
  • Q28R5GF371
  • G0R4UBI2ZZ
  • 4WRK2153H3
  • DD5FO1WKFU
  • 01G9XEA93N
  • 269XH13919
  • CLF5YFS11O
  • S003A158SB
  • H9Y79VD43J
  • 86M454L2TT
  • 789U1901C5
  • 2P299V784P

Pharmacological Class

• Copper [CS]
• Copper-containing Intrauterine Device [EPC]
• Decreased Embryonic Implantation [PE]
• Decreased Sperm Motility [PE]
• Inhibit Ovum Fertilization [PE]
• Non-Standardized Plant Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Allergens [CS]
• Plant Proteins [CS]
• Seed Storage Proteins [CS]

NDC Crossover Matching brand name "Restless Leg" or generic 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"

NDC	Brand Name	Generic Name
55714-2348	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
55714-2349	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
55714-2554	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
55714-2555	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
55714-4612	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
55714-4613	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
55714-4787	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