Home NDC 55714-2555-1 Restless Leg
Product NDC 55714-2555
Requested package NDC 55714-2555-1
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55714-2555 55714-2555-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-2555 55714-2555-1 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55714-2555 55714-2555-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Restless Leg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVICULARIA AVICULARIA 15 [hp_X]/g CAUSTICUM 16 [hp_X]/g CINCHONA OFFICINALIS BARK 15 [hp_X]/g CONIUM MACULATUM FLOWERING TOP 15 [hp_X]/g COPPER 15 [hp_X]/g GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/g HYOSCYAMUS NIGER 15 [hp_X]/g HYPERICUM PERFORATUM 15 [hp_X]/g POTASSIUM CARBONATE 15 [hp_X]/g MAGNESIUM CARBONATE 15 [hp_X]/g MERCURY 15 [hp_X]/g AMANITA MUSCARIA FRUITING BODY 15 [hp_X]/g STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/g LEAD 6 [hp_X]/g TOXICODENDRON PUBESCENS LEAF 15 [hp_X]/g CLAVICEPS PURPUREA SCLEROTIUM 6 [hp_X]/g STRYCHNINE 15 [hp_X]/g LYCOSA TARANTULA 15 [hp_X]/g VALERIAN 15 [hp_X]/g VERBASCUM THAPSUS 15 [hp_X]/g ZINC 15 [hp_X]/g MATRICARIA CHAMOMILLA 15 [hp_X]/g PASSIFLORA INCARNATA FLOWERING TOP 15 [hp_X]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 23 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55714-2555-1 Restless Leg 28 g in 1 BOTTLE, GLASS PELLET 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 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) PELLET [NEWTON LABORATORIES, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20250213_9b3f076e-7edd-ea51-e053-2a95a90abd9b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Newton Laboratories, Inc. 9b3f076e-7edd-ea51-e053-2a95a90abd9b 2025-02-10 Warnings Exact identifier ndc (package): 55714-2555-1 ndc (product): 55714-2555 ndc11 (package): 55714255501
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55714-2555-1 55714255501 28 g in 1 BOTTLE, GLASS (55714-2555-1) 28 g 2019-08-01 0000-00-00 No No Current