Alka-Seltzer Heartburn and Pain ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE 1000 mg; 325 mg; 1916 mg Tablet, Effervescent — NDC 00280-0160-04 package photo

Alka-Seltzer Heartburn and Pain ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE 1000 mg; 325 mg; 1916 mg Tablet, Effervescent

by Bayer HealthCare LLC. · 18 POUCH in 1 CARTON (0280-0160-04) / 2 TABLET, EFFERVESCENT in 1 POUCH
NDC 00280-0160-04
🏷️ FDA NDC (as labeled) 0280-0160-04 billing pads the labeler segment with a zero
This package
Contains2 tablet, effervescent in 1 pouch Pack sizes5 compare ↓
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) 0280-0160-04
Product NDC 0280-0160
11-digit billing NDC 00280016004
RxCUI 1536675
UNII XF417D3PSL, R16CO5Y76E, 8MDF5V39QO
Application # M013
SPL Set ID 2928e140-c868-5bf5-e063-6394a90ab024
Established class (EPC) Calculi Dissolution Agent; Anti-coagulant; Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism of action Acidifying Activity; Calcium Chelating Activity; Cyclooxygenase Inhibitors
Physiologic effect Decreased Coagulation Factor Activity; Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-03
Route ORAL
Dosage form TABLET, EFFERVESCENT
Substance ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE
Why two NDCs? The FDA registers this code as 0280-0160-04 — 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 → 00280-0160-04. 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 Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and derivatives
How it works Cyclooxygenase Inhibitors
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

LabelerBayer HealthCare LLC.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio240 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

🧪 What is this product?

Alka-Seltzer Heartburn and Pain is an over-the-counter effervescent tablet taken by mouth. It contains aspirin, a nonsteroidal anti-inflammatory drug commonly used to relieve minor aches, pains, and fever, along with sodium bicarbonate and citric acid, which function as antacids to help neutralize stomach acid and provide relief from heartburn and indigestion. The effervescent formulation dissolves in water to create a fizzy drink.

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
ImprintASP;SAC
Size25 mm
ScoringNot scored
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.

From the label’s inactive-ingredient sectionnone

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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 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: 2 tablets 2 tablets 2 tablets 2 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
Alka-Seltzer Heartburn and Pain 1000 mg/1; 325 mg/1; 1916 mgthis 00280-0160-04 Bayer 2 tablets FDA listed
Alka-Seltzer Original 1000 mg/1; 325 mg/1; 1916 mg 00280-4000-01 Bayer 2 tablets FDA listed
Walgreens Effervescent Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 00363-0421-68 Walgreens 2 tablets FDA listed
Up and Up Antacid and Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 11673-0187-36 Target 2 tablets FDA listed
Rite Aid Antacid and Pain Relief 325 mg/1; 1000 mg/1; 1916 mg 11822-4212-04 Rite 2 tablets FDA listed
Signature Care Effervescent Antacid and Pain Relief 1916 mg/1; 1000 mg/1; 325 mg 21130-0421-68 Safeway, 2 tablets FDA listed
Kroger Effervescent Antacid and Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 30142-0421-68 Kroger 2 tablets FDA listed
TopCare Effervescent Antacid and Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 36800-0421-68 Topco 2 tablets FDA listed
Effervescent Antacid and Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 37808-0421-68 H. 2 tablets FDA listed
Equaline Effervescent Antacid and Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 41163-0421-68 United 2 tablets FDA listed
Meijer Effervescent Antacid and Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 41250-0222-36 Meijer 2 tablets FDA listed
Care One Original Antacid and Pain Relief 325 mg/1; 1000 mg/1; 1916 mg 41520-0444-36 Foodhold 2 tablets FDA listed
Medique Medi Seltzer 325 mg/1; 1000 mg/1; 1916 mg 47682-0135-20 Unifirst 2 tablets FDA listed
Equate Effervescent Antacid and Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 49035-0421-68 Walmart 2 tablets FDA listed
Bromo Seltzer 1916 mg/1; 1000 mg/1; 325 mg 50201-0421-02 Tower 2 tablets FDA listed
Top Value Effervescent Pain Relief 325 mg/1; 1000 mg/1; 1916 mg 50201-4212-00 Tower 2 tablets FDA listed
Top Value Effervescent Pain Relief 1916 mg/1; 325 mg/1; 1000 mg 50201-4213-06 Tower 2 tablets FDA listed
Alka Seltzer Originial 1s Blister Pack 1000 mg/1; 325 mg/1; 1916 mg 50269-0307-06 JC 2 tablets FDA listed
Good Sense Effervescent Antacid and Pain Relief 1000 mg/1; 1916 mg/1; 325 mg 50804-0421-36 Good 2 tablets FDA listed
Market Basket Effervescent Antacid and Pain Relief 1916 mg/1; 325 mg/1; 1000 mg 53942-0421-36 Demoulas 2 tablets FDA listed
Drug Mart Effervescent Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 53943-0421-36 Discount 2 tablets FDA listed
DG Health Effervescent Antacid and Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 55910-0422-36 DOLGENCORP, 2 tablets FDA listed
Publix Fast Relief Effervescent 325 mg/1; 1916 mg/1; 1000 mg 56062-0421-68 Publix 2 tablets FDA listed
Quality Choice Effervescent Antacid and Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 63868-0229-36 Chain 2 tablets FDA listed
Best Choice Effervescent Antacid Pain Relief 325 mg/1; 1916 mg/1; 1000 mg 63941-0421-12 Valu 2 tablets FDA listed
WinCo Foods Effervescent Antacid and Pain Relief 1916 mg/1; 1000 mg/1; 325 mg 67091-0108-36 WinCo 2 tablets FDA listed
CVS Health Antacid and Pain Reliever 325 mg/1; 1916 mg/1; 1000 mg 69842-0421-36 CVS 2 tablets FDA listed
Alka-Seltzer Original 325 mg/1; 1916 mg/1; 1000 mg 70264-0014-01 R 2 tablets FDA listed
Alka-Seltzer Original 1000 mg/1; 325 mg/1; 1916 mg 85237-1829-01 Select 2 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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 ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE — the ingredient across all brands.

Top reported reactions

Drug Dependence39
Therapeutic Response Unexpected23
Dyspnoea19
Incorrect Drug Administration Duration17
Death15
Choking14
Myocardial Infarction14

Reporter sex

330 reports
Male · 39%
Female · 58%
Unknown · 3%

Serious outcomes

Hospitalization41
Death29
Life-threatening7
Disabling3
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 10 2
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
00280-0160-01 58 POUCH in 1 CARTON (0280-0160-01) / 2 TABLET, EFFERVESCENT in 1 POUCH 2025-02-03 Active
00280-0160-02 6 POUCH in 1 CARTON (0280-0160-02) / 2 TABLET, EFFERVESCENT in 1 POUCH 2025-02-03 Active
00280-0160-03 12 POUCH in 1 CARTON (0280-0160-03) / 2 TABLET, EFFERVESCENT in 1 POUCH 2025-02-03 Active
00280-0160-04 You're viewing this 18 POUCH in 1 CARTON (0280-0160-04) / 2 TABLET, EFFERVESCENT in 1 POUCH 2025-02-03 Active
00280-0160-05 36 POUCH in 1 CARTON (0280-0160-05) / 2 TABLET, EFFERVESCENT in 1 POUCH 2025-02-03 Active

Pack size FAQ

What quantity is in NDC 00280-0160-04?
NDC 00280-0160-04 is listed by the FDA — 18 pouch in 1 carton / 2 tablet, effervescent in 1 pouch.
What NDC number is used to bill for this package of Alka-Seltzer Heartburn and Pain ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE 1000 mg; 325 mg; 1916 mg Tablet, Effervescent?
Bill NDC 00280-0160-04 — the 11-digit billing format is 00280016004. 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 0280-0160-04, 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: 00280-0160-04, written without dashes as 00280016004. 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 00280-0160-04, the first segment (00280) is the labeler code FDA assigned to Bayer HealthCare LLC.; the middle segment (0160) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 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 4 other package presentations of this same product, including 2 tablets (00280-0160-01), 2 tablets (00280-0160-02), 2 tablets (00280-0160-03). 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.

📄 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 35 words

Uses For the temporary relief of minor aches and pains with heartburn, sour stomach, or acid indigestion and upset stomach associated with these symptoms for temporary relief of headaches, body aches, backache and pain alone

⏱️ Dosage and Administration 85 words

Directions Directions ● Completely dissolve 2 tablets in 4 ounces of water and be sure bubbling has stopped before drinking ● Do not exceed recommended dose. SEE WARNINGS adults and children 12 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours adults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours children under 12 years consult a doctor

⚠️ Warnings ~2 min read

Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK.

Consult a doctor if severe stomach pain occurs after taking this product. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have a sodium-restricted diet Ask a doctor or pharmacist before use if you are presently taking a prescription drug.

Antacids may interact with certain prescription drugs. taking a prescription drug for diabetes, gout, or arthritis When using this product do not take more than the maximum daily dosage in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician. Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or a loss of hearing occurs pain get worse or last more than 10 days redness or swelling is present any new symptoms appear If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 32 words

Other information each tablet contains: sodium 568 mg store at room temperature. Avoid excessive heat. Alka-Seltzer Heartburn + Pain in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

🧪 Active Ingredient 26 words

Active ingredients (in each tablet) Purpose Anhydrous citric acid 1000 mg Antacid Aspirin 325 mg (NSAID) nonsteroidal anti-inflammatory drug Analgesic Sodium bicarbonate (heat-treated) 1916 mg Antacid

🧪 Inactive Ingredients 3 words

Inactive ingredients none

🎯 Purpose 26 words

Active ingredients (in each tablet) Purpose Anhydrous citric acid 1000 mg Antacid Aspirin 325 mg (NSAID) nonsteroidal anti-inflammatory drug Analgesic Sodium bicarbonate (heat-treated) 1916 mg Antacid

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.