NDC 65197-300-10 (65197-0300-10) — Gelusil Alumina, Magnesia

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65197-300-10

Product NDC 65197-300

11-digit billing NDC 65197030010

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

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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

Quick answers

GSN (GCN sequence number): 002708
GCN: 63951
GPI-14 (Medi-Span): 48991003100515
HICL (First Databank): 001168
AHFS class code: 56:04.00.00
RxCUI (RxNorm): 211633

Why two NDCs? The FDA registers this code as 65197-300-10 — 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 → 65197-0300-10. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

Label name GELUSIL 200-200-25 MG CHEW TAB Ingredient Mag Hydrox/Aluminum Hyd/Simeth

📖 About the active ingredient MedlinePlus · NLM

General information about the ingredient itself — the description of this specific product follows below.

Aluminum hydroxide is used for the relief of heartburn, sour stomach, and peptic ulcer pain and to promote the healing of peptic ulcers.

Read the full MedlinePlus article ↗

🧪 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.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

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 system	Per each	Per 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: 100 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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
65197-0300-10 You're viewing this Main listing	10 BLISTER PACK in 1 CARTON / 10 TABLET, CHEWABLE in 1 BLISTER PACK	2008-09-24	—	Active
65197-0300-11 65197-300-11	100 TABLET, CHEWABLE in 1 BOTTLE	2018-12-01	—	Active

Pack size FAQ

What quantity is in this package?

This package is listed by the FDA — 10 blister pack in 1 carton / 10 tablet, chewable in 1 blister pack.

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?

Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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 65197-0300-10	WellSpring	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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Sep 3, 2026
CMS NADAC weekly file

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.

FDA Orange Book · refreshed Sep 3, 2026

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.

FDA label on DailyMed · label index refreshed Oct 1, 2026

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.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

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

LabelerWellSpring Pharmaceutical Corporation

FDA applicationM001 (OTC MONOGRAPH DRUG)

Labeler code65197

First marketedSep 2008

Product typeHuman Otc Drug

Portfolio30 products on file

🔎 All NDCs from WellSpring Pharmaceutical Corporation

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 openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel

🎯 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

📄 Ask a Doctor Before Use If 14 words ▾

Ask a doctor before use if you have Kidney disease A magnesium 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.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if symptoms last more than 2 weeks

📄 Keep Out of Reach of Children 22 words ▾

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

📄 Questions or Comments 13 words ▾

📄 Package Label / Principal Display Panel 23 words ▾

Principal display panel - Carton Gelusil Antacid Antigas 10 Blisters Gelusil Antacid 100 Chewable Tablets Gelusil Antacid Antigas Cool mint 100 Chewable Tablets

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

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 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 100 tablets (65197-0300-11). 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.

Related NDC lookups

🧪 All Alumina, Magnesia, Simethicone NDCsSame ingredient 🏭 All WellSpring labeler NDCsLabeler code 65197 📚 All Calculi Dissolution Agent NDCsDrug class

Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Antacids.

Calcium Carbonate/Simethicone 00067-0118-01 Calcium Carbonate 00135-0070-03 Mag/Aluminum/Sod Bicarb/Alginc 00135-0096-26 Sodium Bicarbonate 00536-1046-10 Magnesium Oxide 00603-0209-22 Calcium Carb/Magnesium Hydrox 00904-5115-71 Calcium Carb/Mag Hydrox/Simeth 41167-0104-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

First Databank (licensed) · refreshed Oct 1, 2026

Gelusil Alumina, Magnesia, Simethicone 200 mg; 200 mg; 24 mg; 1 mg Tablet, Chewable — NDC 65197-300-10 (Billing 65197-0300-10)

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

RxNorm drug class

Clinical

Patient education

Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Pack size FAQ

Therapeutic equivalents

Availability & generic status

What it looks like

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

FDA label — Drug Facts FDA SPL

About this NDC listing & data coverage

Questions about this listing

Related NDC lookups

Related drugs in this class