Restless Leg

Product NDC
55714-2555
11-digit product format
557142555
Labeler code
55714
Product ID
55714-2555_2dd1e767-854d-eacb-e063-6294a90abe9e
Type
HUMAN OTC DRUG
Nonproprietary 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
PELLET
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-08-01
Substance
AMANITA 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; ZINC
Active strength
15; 16; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 6; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Restless Leg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMANITA MUSCARIA FRUITING BODY15 [hp_X]/g
AVICULARIA AVICULARIA16 [hp_X]/g
CAUSTICUM15 [hp_X]/g
CINCHONA OFFICINALIS BARK15 [hp_X]/g
CLAVICEPS PURPUREA SCLEROTIUM15 [hp_X]/g
CONIUM MACULATUM FLOWERING TOP15 [hp_X]/g
COPPER15 [hp_X]/g
GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]/g
HYOSCYAMUS NIGER15 [hp_X]/g
HYPERICUM PERFORATUM15 [hp_X]/g
LEAD15 [hp_X]/g
LYCOSA TARANTULA15 [hp_X]/g
MAGNESIUM CARBONATE15 [hp_X]/g
MATRICARIA CHAMOMILLA6 [hp_X]/g
MERCURY15 [hp_X]/g
PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]/g
POTASSIUM CARBONATE15 [hp_X]/g
STRYCHNINE15 [hp_X]/g
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/g
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/g
VALERIAN15 [hp_X]/g
VERBASCUM THAPSUS15 [hp_X]/g
ZINC15 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDIF093I037, 8ZTK6T93B6, DD5FO1WKFU, S003A158SB, 01G9XEA93N, Q28R5GF371, 789U1901C5, 639KR60Q1Q, 4WRK2153H3, XK4IUX8MNB, 2P299V784P, 86M454L2TT, 0E53J927NA, G0R4UBI2ZZ, FXS1BY2PGL, CLF5YFS11O, BQN1B9B9HA, H9Y79VD43J, 269XH13919, 6IO182RP7A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2555-1Restless Leg28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2555RESTLESS 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) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250213_9b3f076e-7edd-ea51-e053-2a95a90abd9b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2555-15571425550128 g in 1 BOTTLE, GLASS (55714-2555-1) 28 g2019-08-010000-00-00NoNoCurrent