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Aluminum hydroxide and Magnesium carbonate 160 mg; 105 mg Tablet, Chewable, 100-count — NDC 76457-0001-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Aluminum hydroxide and Magnesium carbonate 160 mg; 105 mg Tablet, Chewable, 100-count — NDC 76457-001-00 (Billing 76457-0001-00)

by Simpex Pharma Pvt. Ltd · 1 BOTTLE in 1 CARTON / 100 TABLET, CHEWABLE in 1 BOTTLE

This is a package of 100 tablets of Aluminum hydroxide and Magnesium carbonate 160 mg; 105 mg Tablet, Chewable from Simpex Pharma Pvt. Ltd, marketed since Feb 2018 and currently FDA-listed. It is this product's only package size.

NDC 76457-0001-00
🏷️ FDA NDC (as labeled) 76457-001-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76457-001-00
Product NDC 76457-001
11-digit billing NDC 76457000100
RxCUI 308072
UNII 5QB0T2IUN0, 0E53J927NA
Application # M001
SPL Set ID e799a555-bfd0-4298-a5dc-aeb671815d40
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-02-09
Route ORAL
Dosage form TABLET, CHEWABLE
Substance ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE
Quick answers
  • RxCUI (RxNorm): 308072
Why two NDCs? The FDA registers this code as 76457-001-00 — 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 → 76457-0001-00. 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 Drugs for treatment of hyperkalemia and hyperphosphatemia class.

Drug family (ATC) Drugs for treatment of hyperkalemia and hyperphosphatemia, Magnesium compounds, Osmotically acting laxatives
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

🧪 What is this product?

This is a chewable tablet taken by mouth that contains aluminum hydroxide and magnesium carbonate. Both ingredients are antacids, commonly used to neutralize stomach acid and provide relief from heartburn and indigestion. This product is an over-the-counter monograph drug, meaning it is marketed under established FDA guidelines for antacid products rather than as an individually reviewed medication.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76457-0001-00 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 100 TABLET, CHEWABLE in 1 BOTTLE 2018-02-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acid Gone Antacid Extra Strength 160 mg/1; 105 mg 00904-5365-60 Major 100 tablets $0.044 — Availability likely —
GOOD NEIGHBOR PHARMACY Antacid Extra Strength 160 mg/1; 105 mg 46122-0150-78 Amerisource 100 tablets $0.044 — Availability likely —
Extra Strength Antacid Original Flavor 160 mg/1; 105 mg 70000-0234-01 Cardinal 100 tablets $0.044 — Availability likely —
Gaviscon Extra Strength 160 mg/1; 105 mg 00135-0098-26 Haleon 100 tablets — — FDA listed —
Gaviscon Extra Strength 160 mg/1; 105 mg 00135-0430-03 Haleon 100 tablets — — FDA listed —
FAST ACTING Heartburn Relief 160 mg/1; 105 mg 00363-1155-10 WALGREEN 100 tablets — — FDA listed —
Extra Strength Antacid 160 mg/1; 105 mg 11673-0814-00 TARGET 100 tablets — — FDA listed —
Rite Aid Extra Strength 160 mg/1; 105 mg 11822-1050-00 RITE 100 tablets — — FDA listed —
Rite Aid Extra Strength 160 mg/1; 105 mg 11822-1051-00 RITE 100 tablets — — FDA listed —
HEB Extra Strength Original Flavor 160 mg/1; 105 mg 37808-0505-10 HEB 100 tablets — — FDA listed —
HEB Extra Strength Cherry Flavor 160 mg/1; 105 mg 37808-0510-10 HEB 100 tablets — — FDA listed —
Meijer Extra Strength Original Flavor 160 mg/1; 105 mg 41250-0675-10 MEIJER 100 tablets — — FDA listed —
equate Extra Strength Antacid 160 mg/1; 105 mg 49035-0105-10 Wal-Mart 100 tablets — — FDA listed —
CVS PHARMACY Extra Strength Cherry Flavor 160 mg/1; 105 mg 51316-0155-00 CVS 100 tablets — — FDA listed —
CVS Health Extra Strength Heartburn Relief Antacid Original Flavor 160 mg/1; 105 mg 59779-0880-78 CVS 100 tablets — — FDA listed —
Extra Strength Antacid Original Flavor 160 mg/1; 105 mg 63868-0996-01 CHAIN 100 tablets — — FDA listed —
Premier Value Extra Strength Original Flavor 160 mg/1; 105 mg 68016-0105-10 PHARMACY 100 tablets — — FDA listed —
Aluminum hydroxide and Magnesium carbonate 160 mg/1; 105 mgthis 76457-0001-00 Simpex 100 tablets — — FDA listed —
QUALITY CHOICE Original Flavor 160 mg/1; 105 mg 83324-0219-01 CHAIN 100 tablets — — 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

🏛️
2018
On the market since
Feb 2018
📍
2026
Currently FDA-listed
8 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.

What it looks like

Color orange
ShapeRound
Imprint;
Size13 mm
ScoringScored — splits in 2
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 8C3Z4148WZ
    Alginic acid is a natural polymer extracted from brown seaweed. In medicines, it acts as a thickener, binder, and disintegrant to help form tablets and control how quickly the medicine dissolves.
  • UNII 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 3A3U0GI71G
    Magnesium oxide is a mineral compound that acts as a buffer and filler in medications. It helps neutralize stomach acid and adds bulk to the tablet or capsule formulation.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

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

The official label also statesalginic acid, calcium stearate, color red iron oxide, flavor (mint), maize starch, magnesium oxide, mannitol, sodium bicarbonate, sucrose

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.

Manufacturer & labeler

LabelerSimpex Pharma Pvt. Ltd
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code76457
First marketedFeb 2018
Product typeHuman Otc Drug
Portfolio4 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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 10 words ▾

Uses Relieves acid indigestion leading to stomach upset heart burn

⏱️ Dosage and Administration 42 words ▾

Directions chew 2 to 4 tablets four times a day or as directed by a doctor take after meals and at bedtime or as needed for best results follow by a half glass of water or other liquid do not swallow whole

⚠️ Warnings 69 words ▾

Warnings Ask a doctor before use if you have kidney disease a magnesium or sodium-restricted diet Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 16 tablets in a 24-hour period or use the maximum dosage for more than 2 weeks Keep out of reach of children.

🧪 Active Ingredient 15 words ▾

Active ingredient (in each tablet) Aluminum hydroxide, 160 mg Magnesium carbonate, 105 mg Purpose Antacid

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients alginic acid, calcium stearate, color red iron oxide, flavor (mint), maize starch, magnesium oxide, mannitol, sodium bicarbonate, sucrose

🎯 Purpose 2 words ▾

Purpose Antacid

📄 Ask a Doctor Before Use If 15 words ▾

Ask a doctor before use if you have kidney disease a magnesium or sodium-restricted diet

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.

📄 When Using This Product 25 words ▾

When using this product do not take more than 16 tablets in a 24-hour period or use the maximum dosage for more than 2 weeks

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label

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

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 ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE — the ingredient across all brands.

Top reported reactions

Cardiomegaly2
Cerebral Haemorrhage2
Dizziness2
Headache2
Malaise2
Acute Myocardial Infarction1
Adverse Event1

Age at onset

Elderly1

Reporter sex

18 reports
Male · 29%
Female · 71%

Serious outcomes

Hospitalization9
Life-threatening2
Disabling2
Death2
Reports over time (by year) — tap or hover for the count & year
2025 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.

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 Simpex Pharma Pvt. Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Simpex Pharma Pvt. Ltd 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.
← 76451-0118-10 · 3D 76457-0002-00 · Simpex →
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.