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Aspirina Cafeina Aspirin,Caffeine 32.5 mg; 500 mg Tablet, 24-count — NDC 00280-0162-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Aspirina Cafeina Aspirin,Caffeine 32.5 mg; 500 mg Tablet, 24-count — NDC 0280-0162-01 (Billing 00280-0162-01)

by Bayer HealthCare LLC. · 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET in 1 BOTTLE, PLASTIC

This is a package of 24 tablets of Aspirina Cafeina Aspirin,Caffeine 32.5 mg; 500 mg Tablet from Bayer HealthCare LLC., marketed since May 2025 and currently FDA-listed. It is this product's only package size.

NDC 00280-0162-01
🏷️ FDA NDC (as labeled) 0280-0162-01 billing pads the labeler segment with a zero
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) 0280-0162-01
Product NDC 0280-0162
11-digit billing NDC 00280016201
RxCUI 702316
UNII 3G6A5W338E, R16CO5Y76E
UPC 0312843605237
Application # M013
SPL Set ID 2e709acc-325a-baca-e063-6394a90a24be
Established class (EPC) Central Nervous System Stimulant; Methylxanthine; Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Central Nervous System Stimulation; Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical class Xanthines; 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 2025-05-01
Route ORAL
Dosage form TABLET
Substance CAFFEINE; ASPIRIN
Quick answers
  • RxCUI (RxNorm): 702316
Why two NDCs? The FDA registers this code as 0280-0162-01 — 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 → 00280-0162-01. 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.

Clinical

🧪 What is this product?

Aspirina Cafeina is an over-the-counter oral tablet containing aspirin and caffeine. Aspirin is a nonsteroidal anti-inflammatory drug typically used to reduce pain, fever, and inflammation. Caffeine is a central nervous system stimulant commonly combined with pain relievers to enhance their effect. This product is marketed under the FDA's over-the-counter monograph rules for oral pain relievers and stimulants.

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.
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
00280-0162-01 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET in 1 BOTTLE, PLASTIC 2025-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bayer Headache 500 mg/1; 32.5 mg 00280-0064-01 Bayer 100 tablets — — FDA listed —
Aspirina Cafeina 32.5 mg/1; 500 mgthis 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

🏛️
2025
On the market since
May 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.

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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 statescarnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin cera de carnauba, almidón de maíz, laca de aluminio D&C rojo #30, laca de aluminio D&C amarillo #10, hipromelosa, celulosa en polvo, propilenglicol, goma laca, dióxido de titanio, triacetina

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 applicationM013 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedMay 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.

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 📄 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 41 words ▾

Uses/Usos for the temporary relief of headache pain backache pain muscle aches and pains minor aches and pains of arthritis para el alivio temporal de lo siguiente: dolor de cabeza dolor de espalda dolores musculares dolores menores debido a la artritis

⏱️ Dosage and Administration 75 words ▾

Directions/Instrucciones 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 beber un vaso de agua lleno con cada dosis adultos y niños mayores de 12 años: tomar 2 cápsulas cada 6 horas sin exceder 8 cápsulas en 24 horas niños menores de 12 años: consultar al médico

⚠️ Warnings ~1 min read ▾

Warnings/Advertencias 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 Síndrome de Reye: Los niños y adolescentes que tienen varicela, o se están recuperando de ella o tienen síntomas parecidos a los de la gripe, no deben usar este producto.

Cuando se utiliza este producto, si se producen cambios en la conducta y se presentan náuseas y vómitos, consulte a un médico porque estos síntomas podrían ser un signo temprano del síndrome de Reye, una enfermedad rara pero grave. Alerta de alergia: La aspirina puede provocar una reacción alérgica grave que puede incluir: urticaria edema facial asma (sibilancia) choque Advertencia de sangrado estomacal: Este producto contiene un fármaco antiinflamatorio no esteroideo (AINE), que puede causar una grave hemorragia estomacal.

Las posibilidades son mayores si usted tiene 60 años o más ha tenido úlceras estomacales o problemas de sangrado toma un anticoagulante o un medicamento esteroideo toma otros medicamentos que contienen antiinflamatorios no esteroideos (AINE) con o sin receta (aspirina, ibuprofeno, naproxeno u otros) toma 3 o más bebidas alcohólicas todos los días mientras usa este producto

🧪 Active Ingredient 30 words ▾

Active ingredients (in each caplet)/Principios activos (en cada cápsula) Aspirin 500 mg (NSAID)* Caffeine 32.5 mg *nonsteroidal anti-inflammatory drug Aspirina 500 mg (AINE)* Cafeína 32.5 mg *Fármaco antiinflamatorio no esteroideo

🧪 Inactive Ingredients 55 words ▾

Inactive Ingredients/Principios inactivos 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 cera de carnauba, almidón de maíz, laca de aluminio D&C rojo #30, laca de aluminio D&C amarillo #10, hipromelosa, celulosa en polvo, propilenglicol, goma laca, dióxido de titanio, triacetina

🎯 Purpose 9 words ▾

Purpose/Efecto Pain Reliever Pain reliever aid Analgésico Ayuda analgésica

📄 Do Not Use 58 words ▾

Do not use/No lo 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 si es alérgico a la aspirina o a cualquier otro analgésico/antifebril si ha presentado reacciones alérgicas a este producto o a cualquiera de sus componentes

📄 Ask a Doctor Before Use If 91 words ▾

Ask a doctor before use if/Antes de tomar este producto, consulte a su médico en los siguientes casos 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 si la advertencia de sangrado estomacal se aplica a usted si tiene antecedentes de problemas estomacales, como acidez estomacal si tiene hipertensión arterial, enfermedad cardíaca, cirrosis hepática o enfermedad renal si está tomando diuréticos si tiene asma

📄 Ask a Doctor or Pharmacist Before Use If 48 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription drug for/ Consulte a su médico o a un farmacéutico antes de usar este producto si actualmente está tomando un medicamento de venta con receta para gout diabetes arthritis la gota la diabetes la artritis

📄 Stop Use and Ask a Doctor If 171 words ▾

Stop use and ask a doctor if/Suspenda su uso y pregúntele a un médico en los siguientes casos 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 any new symptoms occur ringing in the ears or a loss of hearing occurs si se produce una reacción alérgica.

Busque ayuda médica de inmediato. si presenta cualquiera de los siguientes signos de sangrado estomacal: ●sensación de mareo ● vómitos de sangre ● heces negras o con sangre ●dolor de estómago que no mejora si el dolor empeora o dura más de 10 días si la fiebre empeora o dura más de 3 días si hay enrojecimiento o hinchazón si aparecen nuevos síntomas si tiene zumbido en los oídos o pérdida de la audición

🤰 If Pregnant or Breast-Feeding 108 words ▾

Pregnant/Embarazada 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. Si está embarazada o amamantando, consulte a un profesional de la salud antes de usar este producto.

En especial, es importante no tomar aspirina al llegar a las 20 semanas o más de embarazo, a menos que su médico le indique claramente que lo haga, porque esto puede provocar problemas en el bebé en gestación o complicaciones durante el parto.

📄 Keep Out of Reach of Children 46 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. No dejar al alcance de los niños. En caso de sobredosis, póngase en contacto con un médico o un centro de control de intoxicaciones inmediatamente.

📄 Other Information 27 words ▾

Other Information/Otra información save carton for full directions and warnings Store at room temperature. guarde la caja para consultar las instrucciones y advertencias Almacenar a temperatura ambiente

📄 Questions or Comments 21 words ▾

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST) ¿Preguntas o comentarios? 1-800-331-4536 (lunes a viernes de 9AM - 5PM EST)

📄 Package Label / Principal Display Panel 1 words ▾

PDP

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 ✓ 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 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.
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.
← 00280-0161-01 · Bayer 00280-0211-24 · 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.