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Mylanta Vanilla Caramel Calcium carbonate, magnesium hydroxide, simethicone 800 mg/10mL; 80 mg/10mL; 270 mg/10mL Liquid, 355 mL — NDC 62372-0541-12 package photo

Mylanta Vanilla Caramel Calcium carbonate, magnesium hydroxide, simethicone 800 mg/10mL; 80 mg/10mL; 270 mg/10mL Liquid, 355 mL

by Infirst Healthcare Inc. · 355 mL in 1 BOTTLE (62372-541-12)
NDC 62372-0541-12
🏷️ FDA NDC (as labeled) 62372-541-12 billing pads the product segment with a zero
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) 62372-541-12
Product NDC 62372-541
11-digit billing NDC 62372054112
RxCUI 1788932
UNII H0G9379FGK, 92RU3N3Y1O, NBZ3QY004S
Application # M001
SPL Set ID 10a66d74-74b4-3f8d-e063-6394a90a7f00
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-31
Route ORAL
Dosage form LIQUID
Substance CALCIUM CARBONATE; DIMETHICONE; MAGNESIUM HYDROXIDE
Why two NDCs? The FDA registers this code as 62372-541-12 — 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 → 62372-0541-12. 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

LabelerInfirst Healthcare Inc.
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code62372
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio17 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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
🧪 What is this product?

Mylanta Vanilla Caramel is an oral liquid antacid sold as an over-the-counter monograph drug. It contains calcium carbonate and magnesium hydroxide, which are bases that typically neutralize stomach acid, and simethicone (also called dimethicone), an anti-gas agent commonly used to reduce bloating and gas discomfort. This combination is typically used as a short-term remedy for heartburn, indigestion, and upset stomach.

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
FlavorVanilla
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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII Z944H5SN0H
    A plant-based thickening agent derived from cellulose. It acts as a binder to hold tablet ingredients together and as a thickener in liquid formulations to achieve the right consistency.
  • 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 2P9L47VI5E
    A waxy compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and thickener, helping blend oil and water-based ingredients and giving the medicine a smooth, stable consistency.
  • UNII 14BGY2Y3MJ
    Polysorbate 65 is a synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water in medications, keeping ingredients evenly distributed throughout the product.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesbenzoic acid, benzyl alcohol, edetate disodium, flavor, glycerin, glyceryl monostearate, methylcellulose, microcrystalline cellulose, peg-8 stearate, polysorbate 65, purified water, sodium benzoate, sorbic acid, sucralose, xanthan gum

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 mLPer 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreen Liquid Antacid 800 mg/10mL; 270 mg/10mL; 80 mg/10mL 00363-6701-12 WALGREENS 355 ml — — FDA listed —
DG HEALTH Liquid Antacid plus Anti Gas 800 mg/10mL; 270 mg/10mL; 80 mg/10mL 55910-0670-12 DOLGENCORP, 355 ml — — FDA listed —
Antacid And Antigas 800 mg/10mL; 80 mg/10mL; 270 mg/10mL 57896-0655-12 Geri-Care 355 ml — — FDA listed —
Antacid And Antigas 800 mg/10mL; 80 mg/10mL; 270 mg/10mL 57896-0662-12 Geri-Care 355 ml — — FDA listed —
Antacid And Antigas 800 mg/10mL; 80 mg/10mL; 270 mg/10mL 57896-0666-12 Geri-Care 355 ml — — FDA listed —
Mylanta Classic 800 mg/10mL; 80 mg/10mL; 270 mg/10mL 62372-0501-12 Infirst 355 ml — — FDA listed —
Mylanta New Tonight Soothing Honey Chamomile 800 mg/10mL; 270 mg/10mL; 80 mg/10mL 62372-0510-12 Infirst 355 ml — — FDA listed —
Mylanta Vanilla Caramel 800 mg/10mL; 80 mg/10mL; 270 mg/10mLthis 62372-0541-12 Infirst 355 ml — — FDA listed —
Antacid And Antigas 800 mg/10mL; 80 mg/10mL; 270 mg/10mL 79481-0655-01 Meijer, 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

🏛️
2024
On the market since
Jan 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 Calcium carbonate, magnesium hydroxide, simethicone — the ingredient across all brands.

Top reported reactions

Death1
Product Label Issue1
Vomiting1

Reporter sex

0 reports

Serious outcomes

Death2
Life-threatening1
Disabling1
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
62372-0541-12 You're viewing this 355 mL in 1 BOTTLE (62372-541-12) 2024-01-31 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) ✓ 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 62372-541-12, 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: 62372-0541-12, written without dashes as 62372054112. 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 62372-0541-12, the first segment (62372) is the labeler code FDA assigned to Infirst Healthcare Inc.; the middle segment (0541) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 Infirst Healthcare Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Infirst Healthcare Inc. 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 32 words ▾

Uses relieves: • heartburn • acid indigestion • sour stomach • upset stomach due to these symptoms • pressure and bloating commonly referred to as gas • overindulgence in food and drink

⏱️ Dosage and Administration 74 words ▾

Directions • shake well before use • measure with dosing cup provided • adults and children 12 years and over: 10 mL-20 mL (1-2 doses) as needed, between meals, at bedtime or as directed by a doctor • do not take more than 60 mL (6 doses) in any 24-hour period • do not use the maximum dosage for more than 2 weeks • children under 12 years : ask a doctor • mL=milliliter

⚠️ Warnings 62 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 presently taking a prescription drug. Antacids may interact with certain prescription drugs. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.

🧪 Active Ingredient 13 words ▾

Active ingredients Calcium carbonate 800 mg Magnesium hydroxide 270 mg Simethicone 80 mg

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients benzoic acid, benzyl alcohol, edetate disodium, flavor, glycerin, glyceryl monostearate, methylcellulose, microcrystalline cellulose, peg-8 stearate, polysorbate 65, purified water, sodium benzoate, sorbic acid, sucralose, xanthan gum

🎯 Purpose 4 words ▾

Purposes Antacid Antacid Anti-gas

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62372-0520-16 · Infirst 62372-0542-12 · Infirst →
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.