Home NDC 55714-4787-1 Restless Leg
Product NDC 55714-4787
Requested package NDC 55714-4787-1
11-digit product format 557144787
Labeler code 55714
Product ID 55714-4787_b5e39110-3c2f-7a2c-e053-2a95a90a9c31
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 LIQUID
Route ORAL
Labeler Newton Laboratories, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2019-09-02
Marketing end 0000-00-00
Substance AMANITA MUSCARIA FRUITING BODY; AVICULARIA AVICULARIA; 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 CHAMOMILLA; PASSIFLORA INCARNATA FLOWERING TOP
Active 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
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 2 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 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-4787 55714-4787-1 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 55714-4787 55714-4787-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55714-4787-1 Restless Leg 30 mL in 1 BOTTLE, GLASS LIQUID 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 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) LIQUID [NEWTON LABORATORIES, INC.] 2 Legacy NDC, 1 package rows 20201208_99996c4a-401c-7e29-e053-2a95a90ab0e4.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55714-4787-1 55714478701 30 mL in 1 BOTTLE, GLASS (55714-4787-1) 30 ml 2019-09-02 0000-00-00 No No Current