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Epsom Salt Magnesium sulfate 1 g/g Granule, 454 g — NDC 36800-0395-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Epsom Salt Magnesium sulfate 1 g/g Granule, 454 g — NDC 36800-395-01 (Billing 36800-0395-01)

by TOP CARE (Topco Associates LLC) · 454 g in 1 CARTON

This is a package of 454 g of Epsom Salt Magnesium sulfate 1 g/g Granule from TOP CARE (Topco Associates LLC), marketed since Apr 2014 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 36800-0395-01
🏷️ FDA NDC (as labeled) 36800-395-01 billing pads the product segment with a zero
This package
Contains454 g Pack sizes4 compare ↓
Main listing for product 36800-395 · Also comes in: 454 g 36800-395-10 1810 g 36800-395-04 1814 g 36800-395-40
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-395-01
Product NDC 36800-395
11-digit billing NDC 36800039501
RxCUI 1053346
UNII DE08037SAB
Application # M007
SPL Set ID b1222ba6-390d-478d-905b-994fff4d6d58
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 2014-04-30
Route ORAL, TOPICAL
Dosage form GRANULE
Substance MAGNESIUM SULFATE, UNSPECIFIED
Quick answers
  • RxCUI (RxNorm): 1053346
Why two NDCs? The FDA registers this code as 36800-395-01 — 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 → 36800-0395-01. 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.

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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. The IV injection is used in hospitals to prevent and control seizures in preeclampsia and eclampsia. Epsom salt products by mouth are for occasional cons...
  • Follow your package directions. They generally say to dissolve the dose in a full glass of water and then drink more liquid. It usually works in about 30 minutes to 6 hours. Don't...
  • How do I take Epsom salt for constipation?
  • Flushing, sweating, low blood pressure, and drowsiness are common. Your team also checks your reflexes, breathing and magnesium levels to catch problems early.
📖 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.

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.
Try another pack size: 454 g 1810 g 1814 g
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
36800-0395-01 You're viewing this Main listing 454 g in 1 CARTON 2014-04-30 — Active
36800-0395-04 36800-395-04 1810 g in 1 CARTON 2014-04-30 — Active
36800-0395-10 36800-395-10 454 g in 1 POUCH 2014-04-30 — Active
36800-0395-40 36800-395-40 1814 g in 1 POUCH 2014-04-30 — Active

Pack size FAQ

What quantity is in this package?
This package contains 454 g — 454 g in 1 carton.
How does this package differ from NDC 36800-0395-10?
Both are Epsom Salt Magnesium sulfate 1 g/g Granule — the drug itself is identical. This page's package is the 454 g one, while NDC 36800-0395-10 is the 454 g package.
What NDC number is used to bill for this package of Epsom Salt Magnesium sulfate 1 g/g Granule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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 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 62011-0362-01 Strategic 454 g $0.004 — FDA listed —
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/gthis 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/kg 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
Apr 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.

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 section none

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.

Manufacturer & labeler

LabelerTOP CARE (Topco Associates LLC)
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedApr 2014
Product typeHuman Otc Drug
Portfolio35 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.

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 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours

⏱️ Dosage and Administration 61 words ▾

Directions do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours age dose adults and children 12 years and older 2-4 level teaspoons dissolved in a full glass (8oz) of water children 6 to 11 years 1-2 level teaspoons in a full glass (8oz) of water Not recommended for children under 6 years of age.

⚠️ Warnings 127 words ▾

Warnings Ask a doctor before use if you have kidney disease a magnesium restricted diet stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 2 weeks Ask a doctor or pharmacist before use if you are presently taking a prescription drug. When using this product do not use more than directed Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 6 words ▾

Active ingredient Magnesium sulfate USP 100%

🧪 Inactive Ingredients 3 words ▾

Inactive ingredient none

🎯 Purpose 3 words ▾

Purpose Saline laxative

📄 Ask a Doctor Before Use If 32 words ▾

Ask a doctor before use if you have kidney disease a magnesium restricted diet stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 2 weeks

📄 Ask a Doctor or Pharmacist Before Use If 15 words ▾

Ask a doctor or pharmacist before use if you are presently taking a prescription drug.

📄 When Using This Product 10 words ▾

When using this product do not use more than directed

📄 Stop Use and Ask a Doctor If 37 words ▾

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition. you need to use a laxative for more than 1 week

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Package Label / Principal Display Panel 60 words ▾

Principal Display Panel Epsom Salt MAGNESIUM SULFATE U.S.P. Saline Laxative for Relief of Occasional Constipation Soaking Aid for Minor Sprain and Bruises NET WT OZ (LB) TAMPER EVIDENT: DO NOT USE IF HEAT SEALED POUCH IS IMPROPERLY SEALED. DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 [email protected] www.topcarebrand.com

Package Label TOPCARE HEALTH Epsom Salt Magnesium Sulfate USP 100%

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 TOP CARE (Topco Associates LLC). Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 454 g (36800-0395-10), 1810 g (36800-0395-04), 1814 g (36800-0395-40). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
TOP CARE (Topco Associates LLC) 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.
← 36800-0392-01 · Topco 36800-0398-41 · Topco →
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.