Mag-AL Plus Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL Suspension — NDC 00121-1761-30 package photo

Mag-AL Plus Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL Suspension

by PAI Holdings, LLC dba PAI Pharma · 10 TRAY in 1 CASE (0121-1761-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE
NDC 00121-1761-30
🏷️ FDA NDC (as labeled) 0121-1761-30 billing pads the labeler 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 →

🆔 Identity & classification

FDA NDC (as labeled) 0121-1761-30
Product NDC 0121-1761
11-digit billing NDC 00121176130
NCPDP billing unit ML — per mL (volume)
RxCUI 307746
UNII 5QB0T2IUN0, NBZ3QY004S, 92RU3N3Y1O
Application # M001
SPL Set ID 896ab07a-1b40-43ab-8589-3be86b1c4198
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-01-14
Route ORAL
Dosage form SUSPENSION
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
GCN Seq No 002701
GCN 63910
HICL code 001168
Ingredient (HICL) Mag Hydrox/Aluminum Hyd/Simeth
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4B
Therapeutic class — specific (HIC3) Antacids
AHFS code 56:04.00.00
AHFS class Antacids And Adsorbents
FDB label name MAG-AL PLUS SUSPENS 30 ML CUP
FDB brand name Mag-Al Plus
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0121-1761-30 — a 4-4-2 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 labeler segment → 00121-1761-30. 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 Aluminium compounds class.

Drug family (ATC) Aluminium compounds
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

LabelerPAI Holdings, LLC dba PAI Pharma
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00121
First marketedJan 2004
Product typeHuman Otc Drug
Portfolio142 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

Label name MAG-AL PLUS SUSPENS 30 ML CUP Ingredient Mag Hydrox/Aluminum Hyd/Simeth
🧪 What is this product?

Mag-AL Plus is an over-the-counter oral suspension containing three active ingredients commonly used to relieve heartburn and indigestion. Aluminum hydroxide and magnesium hydroxide are antacids that work to neutralize excess stomach acid. Simethicone (also called dimethicone) functions as an antifoaming agent, typically used to reduce gas and bloating that may accompany acid reflux discomfort. This product is marketed as an OTC monograph drug, meaning it follows FDA's established category rules for antacid combinations.

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.

💊 What it looks like

Color white
FlavorPeppermint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII RN3152OP35
    Hypromellose is a plant-based thickener and film-former derived from cellulose. In medicines, it's used to create coatings on tablets and capsules, control how fast the drug dissolves, and improve the product's texture and stability.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture 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.

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

The official label also statesInactive ingredients butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution

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 $2.25 $6,741.60 / 3000 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
QCH Regular Strength Antacid 509 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 83324-0121-12 Chain 355 ml $0.010 — Availability likely —
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 00536-1293-83 Rugby 355 ml $0.011 — Availability likely —
Regular Strength Antacid/Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 00536-1317-83 RUGBY 355 ml $0.011 — Availability likely —
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 46122-0433-40 AMERISOURCEBERGEN 355 ml $0.011 — Availability likely —
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 46122-0434-40 AMERISOURCEBERGEN 355 ml $0.011 — Availability likely —
Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 70000-0063-01 CARDINAL 355 ml $0.011 — Availability likely —
Regular Strength Antacid And Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 70677-1063-01 STRATEGIC 355 ml $0.011 — Availability likely —
Regular Strength Antacid And Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 70677-1066-01 STRATEGIC 355 ml $0.011 — Availability likely —
Antacid Mint 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63868-0694-57 Chain 355 ml $0.011 — FDA listed —
Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63868-0712-57 Chain 355 ml $0.011 — FDA listed —
Mag-AL Plus 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mLthis 00121-1761-30 PAI 10 cups — — FDA listed —
Advanced Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 00363-1639-12 WALGREEN 355 ml — — FDA listed —
Regular Strength Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 00363-2628-12 WALGREEN 355 ml — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL 00904-7557-73 Major 10 cups — — FDA listed —
Regular Strength Antacid And Gas Relief 200 mg/5mL; 20 mg/5mL; 200 mg/5mL 11822-3324-07 RITE 355 ml — — Discontinued —
Geri-Lanta Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 17856-0630-01 ATLANTIC 50 cups — — FDA listed —
Antacid Plus 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 21130-0629-12 BETTER 355 ml — — FDA listed —
Melox 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 27854-0115-01 Belmora 355 ml — — FDA listed —
Melox 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 27854-0117-01 Belmora 355 ml — — FDA listed —
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 30142-0637-12 KROGER 355 ml — — FDA listed —
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 30142-0639-12 KROGER 355 ml — — FDA listed —
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 36800-0582-40 Topco 355 ml — — FDA listed —
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 37808-0099-12 H 355 ml — — FDA listed —
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 37808-0554-05 H 355 ml — — FDA listed —
Geri-Lanta Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 50090-4259-00 A-S 355 ml — — FDA listed —
Antacid And Gasrelief 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 50804-0629-12 GOODSENSE 355 ml — — FDA listed —
Advanced Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 50804-0639-12 GOODSENSE 355 ml — — FDA listed —
Mag-Al Plus 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 55154-9429-05 Cardinal 5 cups — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL 57237-0316-31 Rising 100 cups — — FDA listed —
Ko-Lanta 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 57896-0004-12 Geri-Care 355 ml — — FDA listed —
Geri-Lanta Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 57896-0629-06 Geri-Care 177 ml — — Discontinued —
Geri-Mox Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 57896-0639-12 Geri-Care 355 ml — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 60687-0877-76 American 10 cups — — FDA listed —
Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63941-0629-12 VALU 355 ml — — FDA listed —
Regular Strength Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 63941-0639-12 VALU 355 ml — — FDA listed —
Regular Strength Antacid/Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 68071-5289-01 NuCare 355 ml — — FDA listed —
Regular Strength Antacid 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 68788-7841-03 Preferred 355 ml — — FDA listed —
Geri-Lanta Antacid Antigas 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 68788-8169-03 Preferred 355 ml — — FDA listed —
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 68788-8506-03 Preferred 355 ml — — FDA listed —
Regular Strength Antacid Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 69256-0503-05 Harris 355 ml — — FDA listed —
Regular Strength Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 69842-0286-12 CVS 355 ml — — FDA listed —
Regular Strength Antacid Mint 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 69842-0355-26 CVS 769 ml — — FDA listed —
Antacid Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 72476-0503-05 Retail 355 ml — — FDA listed —
Antacid 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 72476-0509-05 Retail 355 ml — — FDA listed —
Kesin MAG-AL Plus 200 mg/5mL; 200 mg/5mL; 20 mg/5mL 81033-0006-01 Kesin 100 cups — — FDA listed —
Regular Strength Antacid Antigas 400 mg/10mL; 400 mg/10mL; 40 mg/10mL 83324-0125-12 Chain 355 ml — — FDA listed —
Aluminum Hydroxide, Magnesium Hydroxide and Simethicone 1200 mg/30mL; 1200 mg/30mL; 120 mg/30mL 84415-0017-01 Everpharm 100 cups — — 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

🏛️
2004
On the market since
Jan 2004
📍
2026
Currently FDA-listed
22 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00121-1761-30, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
18K
Units reimbursed last 4 qtrs
395.1K
Gross reimbursed last 4 qtrs
$887.9K
Avg / prescription
$49.40
Avg / unit
$2.2472
Latest quarter Q1 2026
4KRx
Fee-for-service vs managed care ⓘ
20% FFS 80% MCO
Fee-for-service · 3,510 Rx Managed care · 14,463 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 3,744 units · 331 per 100k residents MT North Dakota: 69 units · 8.8 per 100k residents ND Minnesota: 2,509 units · 43.7 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: 450 units · 69.6 per 100k residents VT New Hampshire: 8,985 units · 641 per 100k residents NH Oregon: 7,058 units · 167 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 290 units · 31.6 per 100k residents SD Iowa: 2,790 units · 87.0 per 100k residents IA Illinois: no data reported IL Indiana: 318 units · 4.6 per 100k residents IN Ohio: no data reported OH Pennsylvania: 8,060 units · 62.2 per 100k residents PA New Jersey: 79,284 units · 853 per 100k residents NJ Massachusetts: 1,356 units · 19.4 per 100k residents MA California: 248,788 units · 638 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 2,430 units · 53.7 per 100k residents KY West Virginia: no data reported WV Virginia: 1,575 units · 18.1 per 100k residents VA Maryland: 1,361 units · 22.0 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 16,617 units · 786 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 2,328 units · 32.7 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 645 units · 14.1 per 100k residents LA Mississippi: 240 units · 8.2 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 179 units · 26.4 per 100k residents DC Hawaii: 6,041 units · 421 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.6853
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 853 /100k
2 New Mexico 786 /100k
3 New Hampshire 641 /100k
4 California 638 /100k
5 Hawaii 421 /100k
6 Montana 331 /100k
7 Oregon 167 /100k
8 Iowa 87.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Mag-AL Plus (this brand).

Top reported reactions

Pneumococcal Bacteraemia2
Somnolence2
Acute Kidney Injury1
Back Pain1
Blood Glucose Increased1
Blood Pressure Increased1
Cardiac Failure1

Reporter sex

9 reports
Male · 50%
Female · 50%

Serious outcomes

Hospitalization5
Life-threatening4
Disabling1
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1 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
00121-1761-30 You're viewing this 10 TRAY in 1 CASE (0121-1761-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE 2004-01-14 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) ✓ Available
“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 0121-1761-30, 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: 00121-1761-30, written without dashes as 00121176130. 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 00121-1761-30, the first segment (00121) is the labeler code FDA assigned to PAI Holdings, LLC dba PAI Pharma; the middle segment (1761) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 PAI Holdings, LLC dba PAI Pharma. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PAI Holdings, LLC dba PAI Pharma 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 23 words ▾

USES Uses relieves acid indigestion heartburn sour stomach upset stomach due to these symptoms gas associated with heartburn, sour stomach or acid indigestion

⏱️ Dosage and Administration 42 words ▾

Directions shake well before using mL = milliliters adults and children 12 years of age and older: 30 mL (1 dose) up to 2 times a day or as directed by a doctor children under 12 years of age: ask a doctor

⚠️ Warnings 109 words ▾

Warnings Ask a doctor before use if you have kidney disease a magnesium-restricted diet Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 60 mL (2 doses) in a 24-hour period do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor may cause a laxative effect 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 36 words ▾

Other information each 30 mL contains: magnesium 535 mg , sodium 2 mg store at 20° to 25°C (68° to 77°F) protect from freezing tamper-evident: do not use if seal on cup is missing or torn

🧪 Active Ingredient 23 words ▾

Active Ingredients (in each 30 mL dose) Aluminum hydroxide (equiv. to dried gel, USP) 1200 mg Magnesium hydroxide 1200 mg Simethicone 120 mg

🧪 Inactive Ingredients 17 words ▾

INACTIVE INGREGIENTS Inactive ingredients butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution

🎯 Purpose 3 words ▾

Purposes Antacid Antigas

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