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Theraworx Relief for Muscle Cramps Roll-On MAGNESIUM SULFATE, UNSPECIFIED FORM 6 [hp_X]/mL Aerosol — NDC 61594-0046-00 package photo

Theraworx Relief for Muscle Cramps Roll-On MAGNESIUM SULFATE, UNSPECIFIED FORM 6 [hp_X]/mL Aerosol

by AVADIM HOLDINGS, INC. · 1 BOTTLE in 1 CARTON (61594-046-00) / 89 mL in 1 BOTTLE
NDC 61594-0046-00
🏷️ FDA NDC (as labeled) 61594-046-00 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 24, 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) 61594-046-00
Product NDC 61594-046
11-digit billing NDC 61594004600
NCPDP billing unit ML — per mL (volume)
UNII DE08037SAB
UPC 0850060284236
SPL Set ID 09bd49cd-ace8-49ac-9b83-2926c0436b56
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 2025-01-01
Route TOPICAL
Dosage form AEROSOL
Substance MAGNESIUM SULFATE, UNSPECIFIED FORM
Why two NDCs? The FDA registers this code as 61594-046-00 — a 5-3-2 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 product segment → 61594-0046-00. 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

LabelerAVADIM HOLDINGS, INC.
Labeler code61594
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio16 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?

Theraworx Relief for Muscle Cramps is a topical aerosol roll-on product marketed as a homeopathic preparation containing magnesium sulfate. In homeopathic practice, magnesium sulfate is traditionally used in connection with muscle cramps and related discomfort. Homeopathic products are based on traditional use and are not evaluated by the FDA for effectiveness or safety. This product is marketed under homeopathic tradition rather than as an approved drug.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • 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 76LN7P7UCU
    Lauryl glucoside is a mild plant-based cleansing agent made from coconut oil and glucose. It's used in medicines as a surfactant to help dissolve and distribute ingredients evenly throughout the formulation.
  • UNII JAN3585W85
    A silicone-based compound mixed with polyethylene glycol and polypropylene glycol. It acts as an emulsifier and surfactant to help blend oils and water in liquid medicines, and reduces foam formation during manufacturing.
  • 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 3M4G523W1G
    Silver is a metallic element used in some medications as an antimicrobial agent in topical formulations. It helps prevent bacterial growth on wound dressings and certain skin preparations.
  • 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 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 3NY3SM6B8U
    A microorganism used as a natural source of B vitamins and proteins. In medications, yeast serves as a nutrient supplement and may help with tablet binding or act as a filler to give the product proper form and stability.

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

The official label also states(Alphabetical) Allantoin, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Glycerin, Lauryl Glucoside, Parfum (Fragrance), PEG/PPG-4/12 Dimethicone, Potassium Sorbate, Sodium Benzoate, Tetrasodium EDTA, Tocopheryl Acetate, Xanthan Gum, Yeast Extract

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 eachPer 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
Theraworx Relief for Foot Cramps Foam 6 [hp_X]/mL 61594-0021-00 AVADIM 101 ml — — FDA listed —
Theraworx Relief for Muscle Cramps Roll On 6 [hp_X]/mL 61594-0025-00 AVADIM 74 ml — — FDA listed —
Theraworx Relief for Muscle Cramps Roll-On 6 [hp_X]/mLthis 61594-0046-00 AVADIM 1 bottle — — 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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
61594-0046-00 You're viewing this 1 BOTTLE in 1 CARTON (61594-046-00) / 89 mL in 1 BOTTLE 2025-01-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Theraworx Relief for Muscle Cramps Roll-On MAGNESIUM SULFATE, UNSPECIFIED FORM 6 [hp_X]/mL AEROSOL 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 61594-046-00, 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: 61594-0046-00, written without dashes as 61594004600. 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 61594-0046-00, the first segment (61594) is the labeler code FDA assigned to AVADIM HOLDINGS, INC.; the middle segment (0046) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 AVADIM HOLDINGS, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AVADIM HOLDINGS, 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 11 words ▾

Uses prevents cramps and spasms releases muscle tightness relieves muscle soreness

⏱️ Dosage and Administration 21 words ▾

Directions shake well roll a thin layer to each impacted muscle group and allow to air dry repeat use as needed

⚠️ Warnings 71 words ▾

Warnings For external use only. If eye contact occurs, rinse thoroughly with water. When using this product avoid eye contact store between 32°F and 120°F use only as directed not for ingestion Stop use and ask a doctor if unintended effects occur. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 35 words ▾

Active Ingredient Contains Magnesium Sulfate (Magnesia sulphurica) 6X 0.05% HPUS The letters H.P.U.S. indicate that the componets in this product are officially monograped in the Homepathic Pharmacopoeia of the United States. Purpose Muscle Soreness Relief

🧪 Inactive Ingredients 41 words ▾

Inactive Ingredients (Alphabetical) Allantoin, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Glycerin, Lauryl Glucoside, Parfum (Fragrance), PEG/PPG-4/12 Dimethicone, Potassium Sorbate, Sodium Benzoate, Tetrasodium EDTA, Tocopheryl Acetate, Xanthan Gum, Yeast Extract

🎯 Purpose 4 words ▾

Purpose Muscle Soreness Relief

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61594-0044-00 · AVADIM 61596-0100-10 · GC →
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.