NDC 00280-0064-01 — Bayer Headache Aspirin and caffeine 500 mg;

🆔 Identity & classification

FDA NDC (as labeled) 0280-0064-01

Product NDC 0280-0064

11-digit billing NDC 00280006401

RxCUI 702316

UNII R16CO5Y76E, 3G6A5W338E

UPC 0312843592186

Application # M013

SPL Set ID c0a92873-0914-6a86-e053-2995a90ac41c

Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor; Central Nervous System Stimulant; Methylxanthine

Mechanism of action Cyclooxygenase Inhibitors

Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation; Central Nervous System Stimulation

Chemical class Anti-Inflammatory Agents, Non-Steroidal; Xanthines

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-04-28

Route ORAL

Dosage form TABLET

Substance ASPIRIN; CAFFEINE

Why two NDCs? The FDA registers this code as 0280-0064-01 — 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 → 00280-0064-01. 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 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 marketedApr 2021

Product typeHuman Otc Drug

Portfolio240 products on file

🔎 All NDCs from Bayer HealthCare LLC.

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?

This is an over-the-counter tablet taken by mouth that combines aspirin with caffeine. Aspirin is a nonsteroidal anti-inflammatory drug typically used to relieve minor pain and reduce fever. Caffeine is a central nervous system stimulant commonly included in pain-relief products to enhance their effectiveness. This combination is marketed as an OTC monograph product, meaning it follows the FDA's established rules for this category of pain reliever.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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 R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
UNII 2S42T2808B
A synthetic red dye used as a colorant to give the medicine its red color. It helps make pills or liquids visually distinct and easier to identify.
UNII CQ3XH3DET6
D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII SMD1X3XO9M
Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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.
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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

The official label also statesInactive ingredients carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin

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 system	Per each	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.

Try another pack size: 50 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Bayer Headache 500 mg/1; 32.5 mgthis 00280-0064-01	Bayer	100 tablets	—	—	FDA listed	—
Aspirina Cafeina 32.5 mg/1; 500 mg 00280-0162-01	Bayer	24 tablets	—	—	FDA listed	—
Bayer Back and Body Extra Strength 35.5 mg/1; 500 mg 00280-2150-02	Bayer	200 tablets	—	—	FDA listed	—
pain relief back and body EXTRA STRENGTH 500 mg/1; 32.5 mg 11822-4130-02	Rite	100 tablets	—	—	FDA listed	—
Back and Body 500 mg/1; 32.5 mg 30142-0654-12	Kroger	100 tablets	—	—	FDA listed	—
Back and Body Extra Strength 500 mg/1; 32.5 mg 41250-0143-12	Meijer	100 tablets	—	—	FDA listed	—
Green Guard Extra Strength Pain Relief 500 mg/1; 32.5 mg 47682-0048-80	Unifirst	2 tablets	—	—	FDA listed	—
Medi First Pain Ache 500 mg/1; 32.5 mg 47682-0821-36	Unifirst	2 tablets	—	—	FDA listed	—
Medi First Plus Pain Ache 500 mg/1; 32.5 mg 47682-0921-36	Unifirst	2 tablets	—	—	FDA listed	—
Back and Body Extra Strength 500 mg/1; 32.5 mg 50844-0413-08	L.N.K.	24 tablets	—	—	FDA listed	—
AeroTab Pain Reliever 500 mg/1; 32.5 mg 55305-0135-01	Aero	2 tablets	—	—	FDA listed	—
Back and Body Extra Strength 500 mg/1; 32.5 mg 55910-0134-15	DOLGENCORP,	50 tablets	—	—	FDA listed	—
Back and Body Extra Strength 500 mg/1; 32.5 mg 59779-0143-12	CVS	100 tablets	—	—	FDA listed	—
Back and Body Pain Relief 500 mg/1; 32.5 mg 67091-0430-50	WinCo	50 tablets	—	—	FDA listed	—
Back and Body Extra Strength 500 mg/1; 32.5 mg 70000-0127-01	Cardinal	50 tablets	—	—	Discontinued	—
Thompson XS Pain Ache 32.5 mg/1; 500 mg 73408-0821-80	Thompson	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

🏛️

2021

On the market since

Apr 2021

📍

2026

Currently FDA-listed

5 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 Bayer Headache (this brand).

Top reported reactions

Headache3

Nausea2

Urinary Tract Infection2

Abdominal Discomfort1

Abdominal Pain1

Anaemia1

Back Pain1

Reporter sex

Male · 50%

Female · 50%

Serious outcomes

Hospitalization3

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
00280-0064-01 You're viewing this	1 BOTTLE in 1 CARTON (0280-0064-01) / 100 TABLET in 1 BOTTLE	2021-04-28	Active
00280-0064-02	1 BOTTLE in 1 CARTON (0280-0064-02) / 50 TABLET in 1 BOTTLE	2021-04-28	Active

Pack size FAQ

What quantity is in NDC 00280-0064-01?

NDC 00280-0064-01 is a 100-count package — 1 bottle in 1 carton / 100 tablet in 1 bottle.

What is the difference between NDC 00280-0064-01 and NDC 00280-0064-02?

Both are Bayer Headache Aspirin and caffeine 500 mg; 32.5 mg Tablet — the drug itself is identical. NDC 00280-0064-01 is the 100-count package, while NDC 00280-0064-02 is the 50 tablets package.

What NDC number is used to bill for this package of Bayer Headache Aspirin and caffeine 500 mg; 32.5 mg Tablet?

Bill NDC 00280-0064-01 — the 11-digit billing format is 00280006401. 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	— 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 FDA registers it as 0280-0064-01, 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: 00280-0064-01, written without dashes as 00280006401. 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 00280-0064-01, the first segment (00280) is the labeler code FDA assigned to Bayer HealthCare LLC.; the middle segment (0064) 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 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 1 other package presentation of this same product, including 50 tablets (00280-0064-02). 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.

📄 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

🎯 Indications and Usage 22 words ▾

Uses Uses temporarily relieves minor aches and pains due to: headache toothache colds muscle pain minor pain of arthritis temporarily reduces fever

⏱️ Dosage and Administration 41 words ▾

Directions ● drink a full glass of water with each dose ● adults and children 12 years and over: take 2 caplets every 6 hours not to exceed 8 caplets 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 Do not use ● if you are allergic to aspirin or 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 Ask a doctor or pharmacist before use if you are taking a prescription drug for ● gout ● diabetes ● arthritis 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 pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur ringing in the ears or a loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use . It is especially important not to use aspirin during the last 3 months of 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 overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 20 words ▾

Active ingredients (in each caplet) Purpose Aspirin 500 mg (NSAID)*………………………...................Pain reliever/fever reducer Caffeine 32.5 mg……………………………….....................Pain reliever aid *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin

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

🔗 Related NDC lookups

🧪 All Aspirin And Caffeine NDCsSame ingredient 🏭 All Bayer labeler NDCsLabeler code 00280 📚 All Central Nervous System Stimulant NDCsDrug class

Bayer Headache Aspirin and caffeine 500 mg; 32.5 mg Tablet, 100-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups