GAVISCON aluminum hydroxide and magnesium carbonate 254 mg/5mL; 237.5 mg/5mL Liquid, 355 mL
by Haleon US Holdings LLC · 355 mL in 1 BOTTLE (0135-0574-01)
NDC 00135-0574-01
🏷️ FDA NDC (as labeled)
0135-0574-01
billing pads the labeler segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Sep 10, 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)
0135-0574-01
Product NDC
0135-0574
11-digit billing NDC
00135057401
NCPDP billing unit
ML — per mL (volume)
UNII
5QB0T2IUN0, 0E53J927NA
Application #
M001
SPL Set ID
2d74e5bc-1f10-4fb6-9258-cd906e360013
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2014-08-01
Route
ORAL
Dosage form
LIQUID
Substance
ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE
GPI-14
48990002151840
GPI class
Gaviscon Extra Strength
GCN Seq No
014148
GCN
63371
HICL code
001172
Ingredient (HICL)
Mag Carb/Aluminum Hydrox/Algin
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
GAVISCON EXTRA STRENGTH LIQUID
FDB brand name
Gaviscon
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0135-0574-01 — 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 → 00135-0574-01. 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.
🏭 Manufacturer & labeler
LabelerHaleon US Holdings LLC
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00135
First marketedAug 2014
Product typeHuman Otc Drug
Portfolio404 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 GAVISCON EXTRA STRENGTH LIQUID Ingredient Mag Carb/Aluminum Hydrox/Algin
🧪 What is this product?
Gaviscon is a liquid oral antacid product sold over the counter under FDA's OTC monograph rules for antacids. It contains aluminum hydroxide and magnesium carbonate, which are alkaline compounds typically used to neutralize stomach acid and relieve heartburn and indigestion. This combination is commonly found in antacid formulations designed to provide relief from acid-related discomfort.
Patient education
Supplement & herbal interactions
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.
💬 Questions about aluminum hydroxide and magnesium carbonate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
green / white
FlavorCherry
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.
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 system | Per mL | 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.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Extra Strength Heartburn Relief 254 mg/5mL; 237.5 mg/5mL 70000-0363-01 | CARDINAL | 355 ml | $0.015 | — | Availability likely | — |
| Gaviscon 254 mg/5mL; 237.5 mg/5mL 00135-0095-41 | Haleon | 355 ml | — | — | FDA listed | — |
| Gaviscon 254 mg/5mL; 237.5 mg/5mLthis 00135-0574-01 | Haleon | 355 ml | — | — | FDA listed | — |
| Walgreens Fast Acting Heartburn Relief Extra Strength 254 mg/5mL; 237.5 mg/5mL 00363-7630-12 | WALGREEN | 355 ml | — | — | FDA listed | — |
| HEB Extra Strength Cool Mint 254 mg/5mL; 237.5 mg/5mL 37808-0632-12 | HEB | 355 ml | — | — | FDA listed | — |
| Heartburn Relief 254 mg/5mL; 237.5 mg/5mL 57896-0565-12 | GERI-CARE | 355 ml | — | — | FDA listed | — |
| Heartburn Relief 254 mg/5mL; 237.5 mg/5mL 63868-0565-12 | CHAIN | 355 ml | — | — | FDA listed | — |
| CVS Health Extra Strength Antacid 254 mg/5mL; 237.5 mg/5mL 69842-0376-12 | CVS | 355 ml | — | — | FDA listed | — |
| Extra Strength Heartburn Relief 254 mg/5mL; 237.5 mg/5mL 69842-0628-12 | CVS | 355 ml | — | — | 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
🏛️
2014
On the market since
Aug 2014
📍
2026
Currently FDA-listed
12 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 GAVISCON (this brand).
Top reported reactions
Reporter sex
Male · 39%
Female · 61%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00135-0574-01 You're viewing this | 355 mL in 1 BOTTLE (0135-0574-01) | 2014-08-01 | 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) | — 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 0135-0574-01, 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: 00135-0574-01, written without dashes as 00135057401. 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 00135-0574-01, the first segment (00135) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (0574) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Haleon US Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Haleon US Holdings LLC 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms
⏱️ Dosage and Administration ▾
Directions (Regular Strength) shake well take 1-2 tablespoonfuls four times a day or as directed by a doctor take after meals and at bedtime dispense product only by spoon or other measuring device
Directions (Extra Strength) shake well take 2-4 teaspoonfuls four times a day or as directed by a doctor take after meals and at bedtime dispense product only by spoon or other measuring device
⚠️ Warnings ▾
Warnings Ask a doctor or pharmacist before use if you have kidney disease are on a sodium-restricted diet or a magnesium-restricted diet are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product (Regular Strength) do not take more than 8 tablespoonfuls in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor laxative effect may occur When using this product (Extra Strength) do not take more than 16 teaspoonfuls in 24 hours do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor laxative effect may occur Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information (Regular Strength) each tablespoon (15 mL) contains: magnesium 115 mg, sodium 52 mg store at up to 25°C (77°F). Avoid freezing. keep tightly closed
Other information (Extra Strength) each teaspoon (5 mL) contains: magnesium 75 mg, sodium 11 mg store at up to 25°C (77°F). Avoid freezing. keep tightly closed
🧪 Active Ingredient ▾
Active ingredients (in each 15 mL tablespoonful) Regular Strength Aluminum hydroxide 95 mg Magnesium carbonate 358 mg
Active ingredients (in each 5 mL / teaspoonful) Extra Strength Aluminum hydroxide 254 mg Magnesium carbonate 237.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients (Regular Strength) benzyl alcohol, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, saccharin sodium, sodium alginate, sorbitol solution, water, xanthan gum
Inactive ingredients (Extra Strength Cool Mint) benzyl alcohol, edetate disodium, glycerin, natural and artificial flavors, purified water, simethicone emulsion, sodium alginate, sodium saccharin, sorbitol solution, xanthan gum
Inactive ingredients (Extra Strength Cherry) benzyl alcohol, edetate disodium, glycerin, natural and artificial flavors, purified water, simethicone emulsion, sodium alginate, sodium saccharin, sorbitol solution, xanthan gum
🎯 Purpose ▾
Purposes Antacid Antacid
No label section mentions that — try another word, or open the full label on DailyMed below.
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.