Home › NDC Lookup › Ingredients › Mygale, Agaricus Musc., Causticum, Cinch... › 55714-4787-01
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., Ch 15 [hp_X]/mL; 16 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL Liquid, 30 mL — NDC 55714-4787-01 package photo

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., Ch 15 [hp_X]/mL; 16 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL Liquid, 30 mL

by Newton Laboratories, Inc. · 30 mL in 1 BOTTLE, GLASS (55714-4787-1)
NDC 55714-4787-01
🏷️ FDA NDC (as labeled) 55714-4787-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 55714-4787-1
Product NDC 55714-4787
11-digit billing NDC 55714478701
UNII DIF093I037, 8ZTK6T93B6, DD5FO1WKFU, S003A158SB, Q28R5GF371, 789U1901C5 +12 more
SPL Set ID 99996c4a-401c-7e29-e053-2a95a90ab0e4
Established class (EPC) Copper-containing Intrauterine Device; Non-Standardized Plant Allergenic Extract
Physiologic effect Decreased Embryonic Implantation; Decreased Sperm Motility; Inhibit Ovum Fertilization; Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Copper; Allergens; Plant Proteins; Seed Storage Proteins
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-02
Route ORAL
Dosage form LIQUID
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; ST
Why two NDCs? The FDA registers this code as 55714-4787-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 55714-4787-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerNewton Laboratories, Inc.
Labeler code55714
First marketedSep 2019
Product typeHuman Otc Drug
Portfolio270 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an unapproved homeopathic liquid product taken by mouth that contains multiple plant, mineral, and animal-derived substances. In homeopathic practice, these ingredients are traditionally used to address symptoms associated with restless leg sensations, though homeopathic products are not evaluated by the FDA for effectiveness. The formulation includes plant materials like hypericum and valeriana, mineral substances like copper and lead in highly diluted forms, and other botanical extracts. Homeopathic remedies are based on traditional use rather than modern clinical evidence.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Restless Leg 15 [hp_X]/mL; 16 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mLthis 55714-4787-01 Newton 30 ml — — FDA listed —
Restless Leg 15 [hp_X]/mL; 16 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL 55714-2554-01 Newton 30 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55714-4787-01 You're viewing this 30 mL in 1 BOTTLE, GLASS (55714-4787-1) 2019-09-02 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

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., Ch 15 [hp_X]/mL; 16 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL; 15 [hp_X]/mL LIQUID is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Homeopathic". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 55714-4787-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55714-4787-01, written without dashes as 55714478701. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55714-4787-01, the first segment (55714) is the labeler code FDA assigned to Newton Laboratories, Inc.; the middle segment (4787) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Newton Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Newton Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 24 words ▾

INDICATIONS & USAGE SECTION Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

⏱️ Dosage and Administration 30 words ▾

DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

⚠️ Warnings 43 words ▾

WARNINGS SECTION WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use.

🧪 Active Ingredient 76 words ▾

OTC - ACTIVE INGREDIENT SECTION Equal parts of Chamomilla 6x, Passiflora incarnata 6x, Valeriana officinalis 6x, Agaricus muscarius 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Cuprum metallicum 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Hypericum perforatum 15x, Kali carbonicum 15x, Magnesia carbonica 15x, Mercurius vivus 15x, Nux vomica 15x, Plumbum metallicum 15x, Rhus toxicodendron 15x, Secale cornutum 15x, Strychninum 15x, Tarentula hispana 15x, Valeriana officinalis 15x, Verbascum thapsus 15x, Zincum metallicum 15x, Mygale 16x.

🧪 Inactive Ingredients 15 words ▾

INACTIVE INGREDIENT SECTION Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

🎯 Purpose 24 words ▾

OTC - PURPOSE SECTION Formulated for associated symptoms such as the constant need to move the legs and feet, cramping, jerking, twitching and trembling.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55714-4786-01 · Newton 55714-4788-01 · Newton →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.