Home › NDC Lookup › Ingredients › Alumina, Magnesia, Simethicone › 65197-0300-11
Gelusil Alumina, Magnesia, Simethicone 200 mg; 200 mg; 24 mg; 1 mg Tablet, Chewable, 100-count — NDC 65197-0300-11 package photo

Gelusil Alumina, Magnesia, Simethicone 200 mg; 200 mg; 24 mg; 1 mg Tablet, Chewable, 100-count

by WellSpring Pharmaceutical Corporation · 100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11)
NDC 65197-0300-11
🏷️ FDA NDC (as labeled) 65197-300-11 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also comes in: 10 tablets 65197-0300-10
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) 65197-300-11
Product NDC 65197-300
11-digit billing NDC 65197030011
NCPDP billing unit EA — each (per item)
RxCUI 211633, 307747
UNII 5QB0T2IUN0, NBZ3QY004S, 92RU3N3Y1O, ETJ7Z6XBU4
UPC 0365197300112
Application # M001
SPL Set ID 92fbeec1-1562-40f3-9734-41f133d494f9
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 2008-09-24
Route ORAL
Dosage form TABLET, CHEWABLE
Substance ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED; SILICON DIOXIDE
GPI-14 48991003100515
GPI class Gelusil
GCN Seq No 002708
GCN 63951
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 GELUSIL 200-200-25 MG CHEW TAB
FDB brand name Gelusil
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 65197-300-11 — 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 → 65197-0300-11. 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

LabelerWellSpring Pharmaceutical Corporation
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code65197
First marketedSep 2008
Product typeHuman Otc Drug
Portfolio30 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 GELUSIL 200-200-25 MG CHEW TAB Ingredient Mag Hydrox/Aluminum Hyd/Simeth
🧪 What is this product?

Gelusil is a chewable tablet taken by mouth that contains aluminum hydroxide and magnesium hydroxide, which are antacids typically used to neutralize stomach acid and relieve heartburn and indigestion. The product also includes simethicone, an ingredient commonly used to reduce gas and bloating in the digestive tract. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established category rules rather than as an individually reviewed product.

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.

💊 What it looks like

Color white
ShapeRound
ImprintPD;GELUSIL;034
Size16 mm
ScoringNot scored
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 IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII Z4152N8IUI
    Silicon is a mineral element used in medications as a glidant and anti-caking agent. It helps powders flow smoothly during manufacturing and prevents clumping in tablets and capsules.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.

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

The official label also statesDextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, sucralose

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 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: 10 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
Mintox Plus Tabs 200 mg/1; 200 mg/1; 25 mg 00904-6700-60 Major 100 tablets $0.039 — Availability likely —
Gelusil 200 mg/1; 200 mg/1; 24 mg/1; 1 mgthis 65197-0300-11 WellSpring 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

🏛️
2008
On the market since
Sep 2008
📍
2026
Currently FDA-listed
18 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 Gelusil (this brand).

Top reported reactions

Headache3
Chronic Kidney Disease2
Drug Dependence2
End Stage Renal Disease2
Nausea2
Renal Failure2
Renal Injury2

Age at onset

Adult1
Elderly2

Reporter sex

0 reports
Male · 54%
Female · 46%

Serious outcomes

Hospitalization15
Life-threatening3
Disabling3
Death2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3 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
65197-0300-10 10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 2008-09-24 Active
65197-0300-11 You're viewing this 100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11) 2018-12-01 Active

Pack size FAQ

What quantity is in NDC 65197-0300-11?
NDC 65197-0300-11 is a 100-count package — 100 tablet, chewable in 1 bottle.
What NDC number is used to bill for this package of Gelusil Alumina, Magnesia, Simethicone 200 mg; 200 mg; 24 mg; 1 mg Tablet, Chewable?
Bill NDC 65197-0300-11 — the 11-digit billing format is 65197030011. 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 ✓ 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 65197-300-11, 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: 65197-0300-11, written without dashes as 65197030011. 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 65197-0300-11, the first segment (65197) is the labeler code FDA assigned to WellSpring Pharmaceutical Corporation; the middle segment (0300) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) 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 WellSpring Pharmaceutical Corporation. 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 10 tablets (65197-0300-10). 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?
WellSpring Pharmaceutical Corporation 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 16 words ▾

Uses Relieves: Heartburn Sour stomach Acid indigestion Bloating, pressure and discomfort commonly referred to as gas

⏱️ Dosage and Administration 64 words ▾

Directions Adults and children 12 years of age and older: Chew 2 to 4 tablets. Repeat hourly if symptoms return, or as directed by a physician Children under 12 of age: ask a doctor Do not take more than 12 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

⚠️ Warnings 82 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. Stop use and ask a doctor if symptoms last more than 2 weeks Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away 1.800.222.1222 If pregnant or breastfeeding ask a health professional before use.

🧪 Active Ingredient 18 words ▾

Active Ingredients (in each tablet) Aluminum hydroxide dried gel 200 mg Magnesium hydroxide 200 mg Simethicone 25 mg

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients Dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, sucralose

🎯 Purpose 20 words ▾

Purpose Active ingredients (in each tablet) Purpose Aluminum hydroxide dried gel 200 mg........................Antacid Magnesium hydroxide 200 mg....................................Antacid Simethicone 25 mg......................................................Antigas

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65197-0297-08 · WellSpring 65197-0400-10 · WellSpring →
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.