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Alka-Seltzer Heartburn Relief Lemon Lime Anhydrous citric acid, Sodium bicarbonate (heat-treated) 1650 mg; 1000 mg Tablet, Effervescent — NDC 0280-0083-03 (Billing 00280-0083-03)

by Bayer Healthcare LLC · 36 PACKET in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 PACKET

This is a package of Alka-Seltzer Heartburn Relief Lemon Lime Anhydrous citric acid, Sodium bicarbonate (heat-treated) 1650 mg; 1000 mg Tablet, Effervescent from Bayer Healthcare LLC, marketed since Feb 2022 and currently FDA-listed.

NDC 00280-0083-03
🏷️ FDA NDC (as labeled) 0280-0083-03 billing pads the labeler segment with a zero
This package
Contains2 tablet, effervescent in 1 packet Pack sizes3 compare ↓
Product page 00280-0083-01 Also comes in: 2 tablets 0280-0083-01 2 tablets 0280-0083-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0280-0083-03
Product NDC 0280-0083
11-digit billing NDC 00280008303
RxCUI 2599360
UNII 8MDF5V39QO, 2968PHW8QP
UPC 0016500567301
Application # M001
SPL Set ID cc21af24-9a5b-6831-e053-2a95a90a0af4
Established class (EPC) Anti-coagulant; Calculi Dissolution Agent; Inhibition Large Intestine Fluid/Electrolyte Absorpti
Mechanism of action Acidifying Activity; Calcium Chelating Activity
Physiologic effect Decreased Coagulation Factor Activity; Increased Large Intestinal Motility
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-16
Route ORAL
Dosage form TABLET, EFFERVESCENT
Substance SODIUM BICARBONATE; CITRIC ACID MONOHYDRATE
Quick answers
  • RxCUI (RxNorm): 2599360
Why two NDCs? The FDA registers this code as 0280-0083-03 — 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 → 00280-0083-03. 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 Calculi Dissolution Agent class.

Pharmacologic class Calculi Dissolution Agent, Anti-coagulant
Drug family (ATC) Acid preparations
How it works Calcium Chelating Activity, Acidifying Activity
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 is this product?

Alka-Seltzer Heartburn Relief is an over-the-counter effervescent tablet that dissolves in water and is taken by mouth. It contains sodium bicarbonate and citric acid, which work together to neutralize stomach acid and are typically used to provide temporary relief from heartburn, acid indigestion, and upset stomach. This product is an OTC monograph drug, meaning it follows FDA established rules for its category rather than being individually reviewed as a new drug application.

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.

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
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
00280-0083-01 0280-0083-01 Main listing 18 PACKET in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 PACKET 2022-02-16 — Active
00280-0083-02 0280-0083-02 12 PACKET in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 PACKET 2024-04-01 — Active
00280-0083-03 You're viewing this 36 PACKET in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 PACKET 2024-04-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 36 packet in 1 carton / 2 tablet, effervescent in 1 packet.
What NDC number is used to bill for this package of Alka-Seltzer Heartburn Relief Lemon Lime Anhydrous citric acid, Sodium bicarbonate (heat-treated) 1650 mg; 1000 mg Tablet, Effervescent?
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 Heartburn Relief Lemon Lime 1650 mg/1; 1000 mgthis 00280-0083-03 Bayer 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

🏛️
2022
On the market since
Feb 2022
📍
2026
Currently FDA-listed
4 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.

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.

Manufacturer & labeler

LabelerBayer Healthcare LLC
FDA applicationM001 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedFeb 2022
Product typeHuman Otc Drug
Portfolio27 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.

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 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

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

⏱️ Dosage and Administration 74 words ▾

Directions ● fully dissolve 2 tablets in 4 ounces of water before taking adults and children 12 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 8 tablets in 24 hours adults 60 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 4 tablets in 24 hours children under 12 years consult a doctor

⚠️ Warnings 1 words ▾

Warnings

🧪 Active Ingredient 10 words ▾

Anhydrous citric acid 1000 mg Sodium bicarbonate (heat-treated) 1650 mg

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients aspartame, flavor, magnesium stearate, mannitol

🎯 Purpose 2 words ▾

Antacid 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 11 words ▾

Ask a doctor before use if you have a sodium-restricted diet

📄 Ask a Doctor or Pharmacist 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 9 words ▾

When using this product do not exceed recommended dosage

📄 Stop Use and Ask a Doctor If 16 words ▾

Stop use and ask a doctor if you have taken the maximum dose for 2 weeks

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 41 words ▾

Other information ● each tablet contains: sodium 489 mg ● phenylketonurics: contains phenylalanine 4.5 mg per tablet ● store at room temperature. Avoid excessive heat. ● Alka-Seltzer Lemon Lime in water contains the antacid sodium citrate as the principal active ingredient

📄 Questions or Comments 11 words ▾

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

📄 Package Label / Principal Display Panel 25 words ▾

​ALKA-SELTZER Fast 4-in-1 Relief of: Heartburn Sour Stomach Acid Indigestion Upset Stomach HEARTBURN RELIEF LEMON LIME 36 EFFERVESCENT TABLETS (18 - 2 count pouches) AS_HR_LemonLime_Tablet_36Ctn_r4(002).jpg

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

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, Sodium bicarbonate (heat-treated) — the ingredient across all brands.

Top reported reactions

Weight Decreased4
Headache3
Dizziness2
Dry Skin2
Eructation2
Eye Pain2
Gastrointestinal Disorder2

Age at onset

Adult3
Elderly6

Reporter sex

24 reports
Male · 52%
Female · 48%

Serious outcomes

Hospitalization6
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 8 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.

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) — 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 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 2 other package presentations of this same product, including 2 tablets (00280-0083-01), 2 tablets (00280-0083-02). 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.
← 00280-0079-01 · Bayer 00280-0084-01 · 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.