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Alka-Seltzer Cool Action Heartburn Relief Mint Calcium Carbonate 750 mg Gum, Chewing — NDC 0280-0001-01 (Billing 00280-0001-01)

by Bayer HealthCare LLC. · 2 BLISTER PACK in 1 CARTON / 8 GUM, CHEWING in 1 BLISTER PACK

This is a package of Alka-Seltzer Cool Action Heartburn Relief Mint Calcium Carbonate 750 mg Gum, Chewing from Bayer HealthCare LLC., marketed since Mar 2020 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 00280-0001-01
🏷️ FDA NDC (as labeled) 0280-0001-01 billing pads the labeler segment with a zero
This package
Contains8 gum, chewing in 1 blister pack Pack sizes4 compare ↓
Main listing for product 0280-0001 · Also comes in: 1 gum 0280-0001-03 8 gums 0280-0001-02 10 gums 0280-0001-04
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 0280-0001-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0280 labeler · 0001 product · 01 package
Package marketed since
Mar 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0016500586074
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Calcium Carbonate (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0573-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0561-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0578-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0568-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0579-2026
Class II · May 28, 2026 — Presence of foreign substance: small metallic particles in chewable tablets. (Guardian Drug Co. Inc.) · FDA recall D-0560-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0280-0001-01
Product NDC 0280-0001
11-digit billing NDC 00280000101
RxCUI 2281777
UNII H0G9379FGK
UPC 0016500586074
Application # M001
SPL Set ID 9b8da147-8d0c-e6b0-e053-2a95a90a35e6
Established class (EPC) Blood Coagulation Factor; Cations; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Physiologic effect Increased Coagulation Factor Activity
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 2020-03-01
Route ORAL
Dosage form GUM, CHEWING
Substance CALCIUM CARBONATE
Quick answers
  • RxCUI (RxNorm): 2281777
Why two NDCs? The FDA registers this code as 0280-0001-01 — 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 → 00280-0001-01. 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 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.

Clinical

📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • Most often it's an antacid. It relieves heartburn, acid indigestion, sour stomach and upset stomach tied to those symptoms. A few supplement products have other uses, like bone sup...
  • What is calcium carbonate usually used for?
  • You chew it when symptoms come on. Many labels say to chew or crush the tablets completely and not swallow them whole. The number of tablets varies by product, so read your label o...
  • Many labels say not to use the maximum dose for more than 2 weeks unless a doctor is supervising you. If your symptoms last longer than 2 weeks, check in with your doctor.
📖 Read our full Calcium Carbonate guide →
4
Nutrient depletion considerations

Calcium Carbonate may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Calcium Carbonate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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: 1 gum 8 gums 10 gums
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00280-0001-01 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 8 GUM, CHEWING in 1 BLISTER PACK 2020-03-01 — Active
00280-0001-02 0280-0001-02 1 BLISTER PACK in 1 CARTON / 8 GUM, CHEWING in 1 BLISTER PACK 2020-05-01 — Active
00280-0001-03 0280-0001-03 1 GUM, CHEWING in 1 POUCH 2020-06-01 — Active
00280-0001-04 0280-0001-04 6 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK 2024-11-15 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 blister pack in 1 carton / 8 gum, chewing in 1 blister pack.
What NDC number is used to bill for this package of Alka-Seltzer Cool Action Heartburn Relief Mint Calcium Carbonate 750 mg Gum, Chewing?
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alka-Seltzer Cool Action Heartburn Relief Mint 750 mgthis 00280-0001-01 Bayer 8 gums — — FDA listed —
Alka-Seltzer Heartburn Relief Peppermint 750 mg 00280-0002-01 Bayer 8 gums — — 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

🏛️
2020
On the market since
Mar 2020
📍
2026
Currently FDA-listed
6 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.

What it looks like

Color blue
ShapeRound
Imprint750
Size16 mm
ScoringNot scored
FlavorMint
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.

🧪 Avoiding an ingredient? See Calcium Carbonate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII S870P55O2W
    Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
  • 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statesInactive ingredients acesulfame potassium, butylated hydroxytoluene, copovidone, FD&C Blue No.1 Aluminum Lake, flavors, gum base, isomalt, magnesium stearate, sorbitol, sucralose, talc, titanium dioxide

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.

Manufacturer & labeler

LabelerBayer HealthCare LLC.
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedMar 2020
Product typeHuman Otc Drug
Portfolio240 products on file

More NDCs from Bayer HealthCare LLC. labeler code 00280

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 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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

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

⏱️ Dosage and Administration 63 words ▾

Directions Directions ● adults and children 12 years and over: chew 1 - 2 pieces as symptoms occur or as directed by a doctor ● children under 12 years: consult a doctor ● do not use more than 5 pieces in a 24-hour period ● if pregnant, do not use more than 5 pieces in 24-hour period ● do not swallow the gum

⚠️ Warnings 115 words ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product ● do not use more than 5 pieces in a 24-hour period ● if pregnant do not use more than 5 pieces in a 24-hour period ● do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician If pregnant or breast-feeding, inform your doctor that you are using this product.

Keep out of reach of children.

🧪 Active Ingredient 10 words ▾

Active ingredient (in each chewing piece) Calcium carbonate 750 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients acesulfame potassium, butylated hydroxytoluene, copovidone, FD&C Blue No.1 Aluminum Lake, flavors, gum base, isomalt, magnesium stearate, sorbitol, sucralose, talc, titanium dioxide

🎯 Purpose 2 words ▾

Purpose Antacid

📄 Do Not Use 19 words ▾

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 22 words ▾

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

📄 When Using This Product 54 words ▾

When using this product ● do not use more than 5 pieces in a 24-hour period ● if pregnant do not use more than 5 pieces in a 24-hour period ● do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician

🤰 If Pregnant or Breast-Feeding 13 words ▾

If pregnant or breast-feeding, inform your doctor that you are using this product.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 22 words ▾

Other information ● each piece contains: calcium 300 mg ● store at room temperature. Avoid humidity and excessive heat above 40ºC (104ºF).

📄 Questions or Comments 11 words ▾

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

📄 Package Label / Principal Display Panel 24 words ▾

Carton count 16 pieces Works Fast! Alka-Seltzer® Calcium Carbonate/ Antacid EXTRA STRENGTH COOL ACTION HEARTBURN RELIEF GUM cool mint 16 pieces 16 count carton

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 — Not published for this NDC No photo available yet for this listing.
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 Bayer HealthCare LLC.. 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 3 other package presentations of this same product, including 1 gum (00280-0001-03), 8 gums (00280-0001-02), 10 gums (00280-0001-04). 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?
Bayer HealthCare 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.
← 00276-0801-15 · Misemer 00280-0002-01 · Bayer →
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.