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ROYAL Epsom Salt Magnesium Sulfate 1 kg/kg Granule, For Solution, 1.8 kg — NDC 50438-0001-00 package photo

ROYAL Epsom Salt Magnesium Sulfate 1 kg/kg Granule, For Solution, 1.8 kg

by Filo America · 1.8 kg in 1 BAG (50438-001-00)
NDC 50438-0001-00
🏷️ FDA NDC (as labeled) 50438-001-00 billing pads the product 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) 50438-001-00
Product NDC 50438-001
11-digit billing NDC 50438000100
RxCUI 1053346
UNII DE08037SAB
Application # M007
SPL Set ID 40eb04d2-fcc9-4ee2-8483-99699ea7e386
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 OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-10-29
Route ORAL
Dosage form GRANULE, FOR SOLUTION
Substance MAGNESIUM SULFATE, UNSPECIFIED FORM
Why two NDCs? The FDA registers this code as 50438-001-00 — 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 → 50438-0001-00. 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.

🏷️ RxNorm drug class

This medicine belongs to the Osmotically acting laxatives class.

Drug family (ATC) Osmotically acting laxatives, Magnesium, Electrolyte solutions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerFilo America
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code50438
First marketedOct 2014
Product typeHuman Otc Drug
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

📗 Our plain-language guide HelloPharmacist
  • Most people see results somewhere between 30 minutes and 6 hours after taking it. That's a pretty wide window, so just be prepared and stay close to a bathroom after your dose. Don...
  • Yes, and water really matters here. You need to dissolve your dose in a full 8-ounce glass of water and drink all of it. The water helps the magnesium do its job in your intestines...
  • Does it matter how I take it — like with food or water?
  • This product is designed for occasional constipation — not everyday use. If you find you need a laxative for more than one week straight, that's your sign to talk to a doctor. Rely...
📖 Read our full Magnesium Sulfate guide →
6
Nutrient depletion considerations

Magnesium Sulfate (prescription drug) may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Magnesium Sulfate (prescription drug) nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

From the label’s inactive-ingredient sectionnone

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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
Epsom Salt 1 g/g 70677-0038-01 Strategic 454 g $0.004 — Discontinued —
Epsom Salt 1 g/g 62011-0362-01 Strategic 454 g $0.004 — FDA listed —
Epsom Salt 1 g/g 70000-0021-01 Cardinal 454 g $0.004 — Availability likely —
Epsom Salt 1 g/g 70677-1210-01 Strategic 454 g $0.004 — Availability likely —
Epsom Salt 1 g/g 00363-0395-01 Walgreens 454 g — — FDA listed —
Epsom Salt 1 g/g 00363-0942-05 Walgreen 2721 g — — Discontinued —
Humco Epson Salt 1000 mg/g 00395-0807-16 Humco 454 g — — FDA listed —
Epsom Salt 1 g/g 00869-0602-10 Vi-Jon, 1814 g — — FDA listed —
Epsom Salt 1 g/g 11673-0200-45 Target 1800 g — — FDA listed —
Epsom Salt 1 g/g 21130-0602-01 Safeway 1814 g — — Discontinued —
Epsom Salt 1 g/g 21130-0970-04 Safeway, 1814 g — — FDA listed —
Epsom Salts 100 g/100g 30400-0210-01 Jell 454 g — — FDA listed —
Epsom Salt 1 g/g 36800-0395-01 TOP 454 g — — FDA listed —
Epsom Salt 1 g/g 36800-0602-07 Topco 1814 g — — FDA listed —
Epsom Salt 1 g/g 41163-0602-07 United 1814 g — — FDA listed —
Epsom Salt 1 g/g 41250-0602-07 Meijer, 1814 g — — FDA listed —
Epsom Salt 1 g/g 41250-0929-07 Meijer, 1814 g — — Discontinued —
Epsom Salt 1 g/g 42507-0962-06 Hy-Vee, 454 g — — FDA listed —
365 Whole Foods Market Epsom Salt 1 g/g 42681-0060-01 Whole 1814 g — — FDA listed —
Epsom Salt 1 g/g 42681-6412-01 Whole 1814 g — — FDA listed —
Epsom Salt 1 g/g 42681-6413-01 Whole 2720 g — — FDA listed —
Epsom Salt 1 g/g 46122-0461-19 AmerisourceBergen 1814 g — — Discontinued —
Epsom Salt 1 g/g 49035-0395-01 EQUATE 454 g — — FDA listed —
Epsom Salt 1 g/g 49580-0394-01 P 454 g — — FDA listed —
ROYAL Epsom Salt 1 kg/kgthis 50438-0001-00 Filo 1.8 kg — — FDA listed —
Epsom Salt 1 g/g 50804-0395-01 Good 454 g — — FDA listed —
Epsom Salt 1 g/g 51316-0072-45 CVS 1800 g — — FDA listed —
Epsom Salt 1 g/g 51316-0395-04 CVS 1810 g — — FDA listed —
NATURAL Epsom Salt 100 g/100g 52000-0420-16 Universal 454 g — — FDA listed —
Epsom Salts 100 g/100g 52862-0202-01 International 454 g — — FDA listed —
Epsom Salts 100 g/100g 52862-0203-01 International 454 g — — FDA listed —
Sal Inglesa EPSOM SALT 1 g/g 53145-0580-01 Menper 80 g — — FDA listed —
Epsom Salt 1 g/g 53943-0602-07 Discount 1814 g — — FDA listed —
Epsom Salt 1 g/g 55301-0602-07 Your 1814 g — — FDA listed —
Epsom Salt 1 g/g 55319-0572-02 Family 907 g — — FDA listed —
Rapidol Sal Inglesa 1 g/g 55758-0419-03 Pharmadel 80 g — — FDA listed —
Epsom Salt 1 g/g 55910-0038-07 Old 1814 g — — FDA listed —
Epsom Salt 1 g/g 56062-0952-07 Publix 1814 g — — FDA listed —
Epsom Salts 100 g/100g 58037-0008-01 NEW 454 g — — FDA listed —
Epsom Salt 1 g/g 63941-0602-07 Valu 1814 g — — FDA listed —
Epsom Salt 1 g/g 67091-0352-04 WinCo 1.81 g — — FDA listed —
Epsom Salt 1 g/g 68016-0732-01 Chain 454 g — — FDA listed —
Epsom Salt 1 g/g 68196-0395-07 Sam's 3175 g — — FDA listed —
Epsom Salt 1 g/g 69256-0395-01 Harris 454 g — — FDA listed —
Epsom Salt 1 g/g 69842-0602-04 CVS 2720 g — — Discontinued —
Epsom Salt 1 g/g 70000-0614-01 Cardinal 1814 g — — FDA listed —
Epsom Salt 1 g/g 72036-0602-01 HARRIS 1814 g — — FDA listed —
Epsom Salt 1 g/g 72288-0602-04 Amazon.com 2720 g — — Discontinued —
Epsom Salt 1 g/g 72476-0602-04 Retail 1814 g — — FDA listed —
NuValu Epsom Salt 100 g/100g 72520-0001-12 J 624 g — — FDA listed —
NuValu Epsom Salt 100 g/100g 72520-0002-12 J 454 g — — FDA listed —
Epsom Salt 1 g/g 76162-0029-80 Topco 3630 g — — FDA listed —
Epsom Salt 1 g/g 82442-0017-45 Target 1800 g — — FDA listed —
Epsom Salt 1 g/g 83324-0175-04 Chain 1814 g — — FDA listed —
Epsom Salt 1 g/g 85828-0602-07 Grocery 1814 g — — 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

🏛️
2014
On the market since
Oct 2014
📍
2026
Currently FDA-listed
12 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Magnesium Sulfate (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Magnesium Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$64.1K
Claims incl. refills
2.6K
Beneficiaries
506
Spend / beneficiary
$126.60
Spend / claim
$24.56
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50438-0001-00 You're viewing this 1.8 kg in 1 BAG (50438-001-00) 2014-10-29 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
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 "Otc Monograph Drug". 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 50438-001-00, 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: 50438-0001-00, written without dashes as 50438000100. 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 50438-0001-00, the first segment (50438) is the labeler code FDA assigned to Filo America; the middle segment (0001) 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 Filo America. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Filo America 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 19 words ▾

Uses for relief of occasional constipation (irregularity) this product generally produces a bowel movement in 1/2 to 6 hours

⏱️ Dosage and Administration 89 words ▾

Directions Directions Adults and children 12 years and over - Oral dosage is 10 to 30 grams children 6 to under 12 years of age - Oral dosage is 5 to 10 grams children 2 to under 6 years of age - Oral dosage is 2.5 to 5 grams children under 2 years of age - consult a doctor Drink a full glass (8 ounces) of liquid with each dose. The dose may be taken as a single daily dose or in divided doses. 1 teaspoon equals 5 grams.

⚠️ Warnings 1 words ▾

Warnings

🧪 Active Ingredient 4 words ▾

Active ingredient Magnesium Sulfate

🧪 Inactive Ingredients 3 words ▾

Inactive Ingredients none

🎯 Purpose 2 words ▾

Purpose Laxative

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50428-0033-01 · Dorel 50458-0028-02 · Janssen →
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.