Home › NDC Lookup › Ingredients › Aconitum Napellus, Arnica Montana, Ledum... › 54973-3270-01
Leg Cramps ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUITING TOP 3 [hp_X]/g; 3 [hp_X]/g; 3 [hp_X]/g; 10 [hp_X]/g; 6 [hp_X]/g; 3 [hp_X]/g Ointment, 1 tube — NDC 54973-3270-01 package photo

Leg Cramps ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUITING TOP 3 [hp_X]/g; 3 [hp_X]/g; 3 [hp_X]/g; 10 [hp_X]/g; 6 [hp_X]/g; 3 [hp_X]/g Ointment, 1 tube

by Hyland's Inc. · 1 TUBE in 1 CARTON (54973-3270-1) / 70.9 g in 1 TUBE
NDC 54973-3270-01
🏷️ FDA NDC (as labeled) 54973-3270-1 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) 54973-3270-1
Product NDC 54973-3270
11-digit billing NDC 54973327001
UNII U0NQ8555JD, O80TY208ZW, 877L01IZ0P, HF539G9L3Q, 6IO182RP7A, BK9092J5MP
SPL Set ID 5a298db3-de79-f2a8-e063-6294a90a9408
Established class (EPC) Calculi Dissolution Agent; Osmotic Activity
Mechanism of action Magnesium Ion Exchange Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption; Inhibition Small Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-05-12
Route TOPICAL
Dosage form OINTMENT
Substance ACONITUM NAPELLUS; ARNICA MONTANA; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP
Why two NDCs? The FDA registers this code as 54973-3270-1 — 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 → 54973-3270-01. 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

LabelerHyland's Inc.
Labeler code54973
First marketedMay 2015
Product typeHuman Otc Drug
Portfolio69 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 a homeopathic topical ointment containing six plant-based and mineral ingredients traditionally used in homeopathic practice for leg cramps. The preparation includes arnica montana, aconitum napellus, ledum palustre, toxicodendron pubescens, and viscum album, which are commonly used in homeopathic formulations for muscle discomfort, along with magnesium phosphate, a mineral salt also found in homeopathic remedies. Like all homeopathic products, this ointment is marketed based on homeopathic tradition rather than clinical testing, and the FDA does not evaluate homeopathic drugs for effectiveness.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 8470G57WFM
    Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
  • UNII 2125M16OWN
    A natural plant extract from wintergreen leaves, used as a flavoring agent to add taste to medications and improve how they feel in the mouth.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

12 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesBeeswax, Cetearyl Alcohol, Citric Acid, Potassium Sorbate, Purified Water, Sodium Benzoate, Sodium Stearoyl Glutamate, Vegetable Glycerine, Vegetable Oil, Wintergreen Extract, Xanthan Gum.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 gPer 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
Leg Cramps 3 [hp_X]/g; 3 [hp_X]/g; 3 [hp_X]/g; 10 [hp_X]/g; 6 [hp_X]/g; 3 [hp_X]/g 54973-3202-01 Hyland's 1 tube — — FDA listed —
Leg Cramps 3 [hp_X]/g; 3 [hp_X]/g; 3 [hp_X]/g; 10 [hp_X]/g; 6 [hp_X]/g; 3 [hp_X]/gthis 54973-3270-01 Hyland's 1 tube — — 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

🏛️
2015
On the market since
May 2015
📍
2026
Currently FDA-listed
11 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for LEG CRAMPS (this brand).

Top reported reactions

Abdominal Pain Upper1
Bipolar Disorder1
Carpal Tunnel Syndrome1
Fatigue1
Headache1
Insomnia1
Intentional Dose Omission1

Reporter sex

4 reports
Male · 25%
Female · 75%

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 2 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
54973-3270-01 You're viewing this 1 TUBE in 1 CARTON (54973-3270-1) / 70.9 g in 1 TUBE 2025-12-15 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Leg Cramps ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUITING TOP 3 [hp_X]/g; 3 [hp_X]/g; 3 [hp_X]/g; 10 [hp_X]/g; 6 [hp_X]/g; 3 [hp_X]/g OINTMENT 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) ✓ 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 54973-3270-1, 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: 54973-3270-01, written without dashes as 54973327001. 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 54973-3270-01, the first segment (54973) is the labeler code FDA assigned to Hyland's Inc.; the middle segment (3270) 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 Hyland's Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hyland's 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 14 words ▾

Uses Helps temporarily relieve the symptoms of cramps and pains in legs and calves.

⏱️ Dosage and Administration 31 words ▾

Directions Adults and children 6 years and over: ■ Apply liberally to affected area. ■ Repeat until relieved, up to 4 times per day. ■ Do not use other than directed.

⚠️ Warnings 47 words ▾

Warnings For external use only. Keep away from eyes. Do not use on open wounds. Stop use and ask a doctor if symptoms persist for more than 7 days or worsen. If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children.

🧪 Active Ingredient 61 words ▾

Active ingredients Active ingredients Purpose Aconitum Napellus 3X HPUS pain in joints and legs Arnica Montana 3X HPUS stiffness, muscle soreness and pain Ledum Palustre 3X HPUS pain and cramps in legs Magnesium Phosphorica 10X HPUS muscle cramps Rhus Toxicodendron 6X HPUS pain and stiffness Viscum Album 3X HPUS pain in joints "HPUS" is the Homeopathic Pharmacopoeia of the United States.

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients Beeswax, Cetearyl Alcohol, Citric Acid, Potassium Sorbate, Purified Water, Sodium Benzoate, Sodium Stearoyl Glutamate, Vegetable Glycerine, Vegetable Oil, Wintergreen Extract, Xanthan Gum.

🎯 Purpose 12 words ▾

Purpose Temporarily relieves symptoms of cramps or pain in legs or calves.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 54973-3257-01 · Hyland's 54973-3274-01 · Hyland's →
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.