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Rolaids ULTRA STRENGTH 1200 Calcium Carbonate, Magnesium Hydroxide 1000 mg; 200 mg Tablet, Chewable, 10-count

by THE PROCTER & GAMBLE MANUFACTURING COMPANY · 10 TABLET, CHEWABLE in 1 PACKAGE (84126-325-10)
NDC 84126-0325-10
🏷️ FDA NDC (as labeled) 84126-325-10 billing pads the product segment with a zero
This package
Contains10-count Pack sizes2 compare ↓
Also comes in: 72 tablets 84126-0325-72
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 →

🆔 Identity & classification

FDA NDC (as labeled) 84126-325-10
Product NDC 84126-325
11-digit billing NDC 84126032510
RxCUI 1438105, 1438107
UNII H0G9379FGK, NBZ3QY004S
UPC 0720112004535
Application # M001
SPL Set ID 28d9897d-46bf-d206-e063-6394a90a2b27
Established class (EPC) Blood Coagulation Factor; Calculi Dissolution Agent; Cations; Inhi
Physiologic effect Increased Coagulation Factor Activity; Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-09
Route ORAL
Dosage form TABLET, CHEWABLE
Substance CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
Why two NDCs? The FDA registers this code as 84126-325-10 — 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 → 84126-0325-10. 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 Calcium compounds class.

Drug family (ATC) Calcium compounds, Calcium
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

LabelerTHE PROCTER & GAMBLE MANUFACTURING COMPANY
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code84126
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio846 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

🧪 What is this product?

Rolaids Ultra Strength is a chewable tablet taken by mouth that contains calcium carbonate and magnesium hydroxide. Both ingredients are antacids, meaning they are commonly used to neutralize stomach acid and provide temporary relief from heartburn, acid indigestion, and upset stomach. This product is an over-the-counter monograph drug, which means it is sold under FDA's established rules for antacid products rather than as an individually approved medication.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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.
Try another pack size: 72 tablets
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
Rolaids Ultra Strength Mint 1000 mg/1; 200 mg 41167-1003-01 Chattem, 72 tablets FDA listed
Rolaids Ultra Strength Antacid Assorted Fruit 1000 mg/1; 200 mg 69423-0825-10 THE 10 tablets FDA listed
Rolaids Ultra Strength Mint 1000 mg/1; 200 mg 69423-0828-10 THE 10 tablets FDA listed
Rolaids Ultra Strength 1200 1000 mg/1; 200 mg 84126-0322-10 THE 10 tablets FDA listed
Rolaids ULTRA STRENGTH 1200 1000 mg/1; 200 mgthis 84126-0325-10 THE 10 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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 Rolaids Ultra Strength 1200 (this brand).

Top reported reactions

Chronic Kidney Disease1
Renal Failure1
Renal Haemangioma1

Reporter sex

1 reports
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
84126-0325-10 You're viewing this 10 TABLET, CHEWABLE in 1 PACKAGE (84126-325-10) 2024-12-09 Active
84126-0325-72 72 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (84126-325-72) 2024-12-09 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 84126-0325-10?
NDC 84126-0325-10 is a 10-count package — 10 tablet, chewable in 1 package.
What is the difference between NDC 84126-0325-10 and NDC 84126-0325-72?
Both are Rolaids ULTRA STRENGTH 1200 Calcium Carbonate, Magnesium Hydroxide 1000 mg; 200 mg Tablet, Chewable — the drug itself is identical. NDC 84126-0325-10 is the 10-count package, while NDC 84126-0325-72 is the 72 tablets package.
What NDC number is used to bill for this package of Rolaids ULTRA STRENGTH 1200 Calcium Carbonate, Magnesium Hydroxide 1000 mg; 200 mg Tablet, Chewable?
Bill NDC 84126-0325-10 — the 11-digit billing format is 84126032510. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 84126-325-10, 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: 84126-0325-10, written without dashes as 84126032510. 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 84126-0325-10, the first segment (84126) is the labeler code FDA assigned to THE PROCTER & GAMBLE MANUFACTURING COMPANY; the middle segment (0325) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 THE PROCTER & GAMBLE MANUFACTURING COMPANY. 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 1 other package presentation of this same product, including 72 tablets (84126-0325-72). 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?
THE PROCTER & GAMBLE MANUFACTURING COMPANY 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 16 words

Uses for the relief of: heartburn acid indigestion sour stomach upset stomach associated with these symptoms

⏱️ Dosage and Administration 20 words

Directions adults and children 12 years and over: 2-3 chewable tablets as symptoms occur, or as directed by a doctor

⚠️ Warnings 88 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 now taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 7 tablets 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 If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

🧪 Active Ingredient 14 words

Active ingredients (in each chewable tablet) Calcium carbonate 1000 mg Magnesium hydroxide 200 mg

🧪 Inactive Ingredients 19 words

Inactive ingredients carboxymethylcellulose sodium, corn starch, dextrose, flavors, magnesium stearate, maltodextrin, silicon dioxide, sucralose, sucrose, water, xanthan gum, xylitol

🎯 Purpose 3 words

Purposes Antacid Antacid

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.