Restless Leg
- Product NDC
- 55714-4613
- 11-digit product format
- 557144613
- Labeler code
- 55714
- Product ID
- 55714-4613_a7de20a6-c9f7-0303-22e1-659794b081bb
- Type
- HUMAN PRESCRIPTION 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
- 2011-06-01
- Marketing end
- 0000-00-00
- Substance
- 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 strength
- 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
- 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
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 55714-4613 | I | Inactivated by FDA | 2026-07-31 | ||
| excluded package | package | 55714-4613 | 55714-4613-1 | I | Inactivated by FDA | 2026-07-31 | |
| excluded package | package | 55714-4613 | 55714-4613-2 | I | Inactivated by FDA | 2026-07-31 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c599c4a0-705d-4ebb-ab1f-977af038f96a | Product name | 1 | 20251124 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4613-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-581e-f424-e053-dadaa90a57ce | Restless Leg |
| 55714-4613-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-581e-f424-e053-dadaa90a57ce | Restless Leg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4613-1 | Restless Leg | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-4613-2 | Restless Leg | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 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) PELLET [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 2 package rows | 20131121_6b02dbf8-bde2-ad93-452c-3d879395f3f1.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 55714-4613-1 | 55714461301 | 28.35 g in 1 BOTTLE, GLASS | 28.35 g | Historical |
| 55714-4613-2 | 55714461302 | 56.7 g in 1 BOTTLE, GLASS | 56.7 g | Historical |