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MILK OF MAGNESIA magnesium hydroxide 1200 mg/15mL Suspension, 355 mL — NDC 80447-0649-12 package photo

MILK OF MAGNESIA magnesium hydroxide 1200 mg/15mL Suspension, 355 mL

by Fact Products · 355 mL in 1 BOTTLE (80447-649-12)
NDC 80447-0649-12
🏷️ FDA NDC (as labeled) 80447-649-12 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) 80447-649-12
Product NDC 80447-649
11-digit billing NDC 80447064912
RxCUI 253017
UNII NBZ3QY004S
Application # M007
SPL Set ID aebbdd10-0650-6efe-e053-2a95a90a0ab2
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 2020-09-01
Route ORAL
Dosage form SUSPENSION
Substance MAGNESIUM HYDROXIDE
Why two NDCs? The FDA registers this code as 80447-649-12 — 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 → 80447-0649-12. 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 Magnesium compounds class.

Drug family (ATC) Magnesium compounds, Other urologicals
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

LabelerFact Products
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code80447
First marketedSep 2020
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

📖 What it is MedlinePlus · NLM

Magnesium hydroxide is used to treat occasional constipation in children and adults on a short-term basis. Magnesium hydroxide is in a class of medications called saline laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product you pick up. Most magnesium hydroxide products — like Dulcolax liquid, Colace Fast-Acting Saline Laxative, MiraFAST soft chews, and many Milk of Magnesia...
  • What is magnesium hydroxide actually used for?
  • Yes, a few things matter here. If you're taking a liquid or suspension, shake it well before every use. Whatever form you take, follow it with a full 8-ounce glass of water or anot...
  • How should I take it — does it matter when or how I drink it?
📖 Read our full Magnesium Hydroxide guide →
3
Nutrient depletion considerations

Magnesium Hydroxide (OTC drug) may be associated with lower levels of 3 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Magnesium Hydroxide (OTC 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.

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

  • UNII DY38VHM5OD
    Sodium hypochlorite is a chemical compound commonly used as a disinfectant and antimicrobial agent. In medicines, it may serve as a preservative or antimicrobial component to help prevent bacterial growth and contamination in 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.

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

The official label also statespurified water, sodium hypochlorite

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 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
Milk Of Magnesia Mint 1200 mg/15mL 00536-2470-85 Rugby 473 ml $0.007 — Availability likely —
Milk Of Magnesia Original 1200 mg/15mL 00904-0788-16 MAJOR 473 ml $0.007 — Availability likely —
Milk Of Magnesia Cherry 1200 mg/15mL 63868-0310-12 Chain 355 ml $0.009 — FDA listed —
Milk Of Magnesia 1200 mg/15mL 00536-1319-83 RUGBY 355 ml $0.010 — Availability likely —
Milk Of Magnesia Cherry 1200 mg/15mL 46122-0435-40 AMERISOURCEBERGEN 355 ml $0.010 — Availability likely —
Milk Of Magnesia Mint 1200 mg/15mL 46122-0436-40 AMERISOURCEBERGEN 355 ml $0.010 — Availability likely —
Milk Of Magnesia 1200 mg/15mL 46122-0437-40 AMERISOURCEBERGEN 355 ml $0.010 — Availability likely —
Milk Of Magnesia 1200 mg/15mL 70000-0061-01 CARDINAL 355 ml $0.010 — Availability likely —
Milk Of Magnesia Mint 1200 mg/15mL 70000-0065-01 CARDINAL 355 ml $0.010 — Availability likely —
Milk Of Magnesia 1200 mg/15mL 70677-1072-01 Strategic 355 ml $0.010 — Availability likely —
Milk Of Magnesia 1200 mg/15mL 70677-1073-01 STRATEGIC 355 ml $0.010 — Availability likely —
Milk Of Magnesia 1200 mg/15mL 70677-1074-01 STRATEGIC 355 ml $0.010 — Availability likely —
Milk of Magnesia 2400 mg/30mL 00121-0431-30 PAI 10 cups — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 00363-0647-12 WALGREEN 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 00363-0649-12 WALGREEN 355 ml — — FDA listed —
Gentle Laxative 1200 mg/15mL 00363-1634-12 WALGREEN 355 ml — — FDA listed —
Milk Of Magnesia Cherry 1200 mg/15mL 00363-1648-12 WALGREEN 355 ml — — FDA listed —
Humco Milk of Magnesia 80 mg/mL 00395-1672-16 Humco 473 ml — — FDA listed —
Milk of Magnesia 2400 mg/30mL 00904-7564-73 Major 10 cups — — FDA listed —
Milk Of Magnesia Cherry 1200 mg/15mL 11822-0399-04 RITE 355 ml — — Discontinued —
Milk Of Magnesia 1200 mg/15mL 11822-3329-08 RITE 355 ml — — Discontinued —
Milk Of Magnesia Original 1200 mg/15mL 17856-0788-01 ATLANTIC 10 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 21130-0649-12 BETTER 355 ml — — FDA listed —
Milk of Magnesia 1200 mg/15mL 30142-0547-12 KROGER 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 30142-0649-12 KROGER 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 36800-0649-12 TOP 355 ml — — FDA listed —
Milk of Magnesia mint 1200 mg/15mL 36800-0674-12 TOP 355 ml — — FDA listed —
Milk Of Magnesia Cherry 1200 mg/15mL 36800-0684-12 TOP 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 37808-0064-12 H 355 ml — — FDA listed —
Milk Of Magnesia Mint 1200 mg/15mL 37808-0889-12 H 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 37808-0901-12 H 355 ml — — FDA listed —
Dulcolax Liquid 1200 mg/15mL 41167-0291-00 Chattem, 354 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 49035-0636-12 Wal-Mart 355 ml — — Discontinued —
Milk Of Magnesia 1200 mg/15mL 49035-0649-26 Wal-Mart 769 ml — — FDA listed —
Milk Of Magnesia Mint 1200 mg/15mL 50804-0647-12 GOOD 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 50804-0648-12 GOODSENSE 355 ml — — FDA listed —
Milk Of Magnesia Original 1200 mg/15mL 50804-0649-12 GOODSENSE 355 ml — — FDA listed —
Milk of Magnesia 400 mg/5mL 55154-9403-05 Cardinal 5 cups — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 55319-0647-12 FAMILY 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 55319-0648-12 FAMILY 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 55910-0649-12 DOLGENCORP, 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 56062-0649-12 Publix 355 ml — — FDA listed —
Milk of Magnesia 2400 mg/30mL 57237-0314-31 Rising 100 cups — — FDA listed —
Gentle Laxative 1200 mg/15mL 57896-0615-12 GERI-CARE 355 ml — — FDA listed —
Milk Of Magnesia Mint 1200 mg/15mL 57896-0647-12 Geri-Care 355 ml — — FDA listed —
Milk Of Magnesia Cherry 1200 mg/15mL 57896-0648-12 Geri-Care 355 ml — — FDA listed —
Milk Of Magnesia Original 1200 mg/15mL 57896-0649-12 Geri-Care 355 ml — — FDA listed —
milk of magnesia 1200 mg/15mL 59779-0332-35 CVS 769 ml — — Discontinued —
Milk Of Magnesia Original 1200 mg/15mL 60687-0429-76 American 10 cups — — FDA listed —
Milk of Magnesia 400 mg/5mL 63739-0196-10 McKesson 10 cups — — Discontinued —
Milk Of Magnesia Original 1200 mg/15mL 63868-0787-57 Chain 355 ml — — FDA listed —
Milk Of Magnesia Mint 1200 mg/15mL 63868-0788-57 Chain 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 63941-0647-12 VALU 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 63941-0648-12 VALU 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 63941-0649-12 VALU 355 ml — — FDA listed —
Premier Value Milk of Magnesia 80 mg/mL 68016-0850-16 Pharmacy 473 ml — — FDA listed —
Milk Of Magnesia Mint 1200 mg/15mL 68788-8638-03 Preferred 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 69842-0278-81 CVS 355 ml — — FDA listed —
Milk Of Magnesia Cherry 1200 mg/15mL 69842-0318-79 CVS 769 ml — — FDA listed —
Milk Of Magnesia Cherry 1200 mg/15mL 69842-0332-92 CVS 355 ml — — FDA listed —
Careone Milk of magnesia Original Milk of Magnesia Original 1200 mg/15mL 72476-0661-05 Retail 355 ml — — FDA listed —
CareOne Milk of Magnesia Cherry 1200 mg/15mL 72476-0665-05 Retail 355 ml — — FDA listed —
Gentle Laxative 1200 mg/15mL 79481-0195-01 MEIJER, 355 ml — — FDA listed —
Milk of Magnesia mint 1200 mg/15mL 79481-0647-01 Meijer, 769 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 79481-0648-01 Meijer, 769 ml — — FDA listed —
Gentle Laxative 1200 mg/15mL 79903-0324-12 WALMART 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mLthis 80447-0649-12 Fact 355 ml — — FDA listed —
Milk of Magnesia 400 mg/5mL 81033-0014-52 Kesin 100 cups — — FDA listed —
Milk Of Magnesia Original 1200 mg/15mL 83324-0188-12 Chain 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 85740-0647-12 Power 355 ml — — FDA listed —
Milk Of Magnesia Cherry 1200 mg/15mL 85740-0648-12 Power 355 ml — — FDA listed —
Milk Of Magnesia 1200 mg/15mL 85740-0649-12 Power 355 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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 MILK OF MAGNESIA (this brand).

Top reported reactions

Constipation1,264
Chronic Kidney Disease1,007
Fall1,002
Pain979
Hypotension746
Acute Kidney Injury717
Nausea684

Reporter sex

9,254 reports

Serious outcomes

Hospitalization4,507
Life-threatening614
Disabling436
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 678 209
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
80447-0649-12 You're viewing this 355 mL in 1 BOTTLE (80447-649-12) 2020-09-01 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 80447-649-12, 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: 80447-0649-12, written without dashes as 80447064912. 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 80447-0649-12, the first segment (80447) is the labeler code FDA assigned to Fact Products; the middle segment (0649) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 Fact Products. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fact Products 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

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

⏱️ Dosage and Administration 83 words ▾

Directions • shake well before use • do not exceed the maximum recommended daily dose in a 24 hour period • dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor • drink a full glass (8 oz) of liquid with each dose age dose adults and children 12 years and over 30 mL to 60 mL children 6 to 11 years 15 mL to 30 mL children under 6 years ask a doctor

⚠️ Warnings 127 words ▾

Warnings Ask a doctor before use if you have • kidney disease • a magnesium-restricted diet • stomach pain, nausea, or vomiting • a sudden change in bowel habits that lasts over 14 days Ask a doctor or pharmacist before use if you are taking a prescription drug. This product may interact with certain prescription drugs. Stop use and ask a doctor if • you have rectal bleeding or no bowel movement after using this product.

These could be signs of 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 right away.

📦 Storage and Handling 20 words ▾

Other information • each 15 mL contains: magnesium 500 mg • avoid freezing • store at room temperature tightly closed

🧪 Active Ingredient 10 words ▾

Active ingredient (in each 15 mL) Magnesium hydroxide 1200 mg

🧪 Inactive Ingredients 6 words ▾

Inactive ingredients purified water, sodium hypochlorite

🎯 Purpose 3 words ▾

Purpose Saline laxative

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80446-0401-01 · Immunocore 80465-0003-04 · EROS →
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.