Over-the-counter medicine
Acetaminophen and aspirin and caffeine Brand names: Excedrin; first approved as Excedrin (Migraine Relief)
Acetaminophen and aspirin and caffeine (Excedrin) is an over-the-counter medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 39 generic labelers, and pharmacies paid $0.0648 per unit (Migraine 250-250-65 mg cplt) in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the acetaminophen and aspirin and caffeine FDA label on DailyMed (effective June 25, 2025, Haleon US Holdings LLC); the NDA 20802 record on Drugs@FDA; every acetaminophen and aspirin and caffeine label on DailyMed.
Highlights of the record
FDA label of June 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetreats migraine
Forms and strengths
- 250 mg / 250 mg / 65 mg
- 250 mg / 65 mg / 250 mg
Film-coated tablet; tablet; coated tablet.
On the market
- Earliest approval on file
- January 14, 1998 Excedrin (Migraine Relief), Haleon Us Holdings; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first November 26, 2001; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 44 of which 39 under generic applications, 5 under brand applications, repackagers included; 51 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.0648 per unit Migraine 250-250-65 mg cplt
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 1 Class I among all firms' recalls; latest July 11, 2024
- FAERS reports
- 21,416 through July 30, 2026
What is acetaminophen and aspirin and caffeine used for?
From the label: indications and usagetreats migraine
Conditions named in the indications of acetaminophen and aspirin and caffeine's FDA labels, with every medicine labeled for each:
From other acetaminophen and aspirin and caffeine labelsCough and cold: Headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps
Pain: Uses temporarily relieves minor pain due to headache arthritis backache a cold menstrual cramps muscle aches
Fever: Uses temporarily relieves minor aches and pains due to: headache muscular aches minor arthritis pain backache common cold menstrual cramps toothache temporarily reduces fever
FDA pharmacologic class: Central Nervous System Stimulant, Methylxanthine, Nonsteroidal Anti-inflammatory Drug and Platelet Aggregation Inhibitor.
Source: FDA drug label (EXCEDRIN MIGRAINE), Haleon US Holdings LLC, effective June 25, 2025 (SPL set 7ed841fb-a61c-4868-b4e5-4f2311a5e79c), via openFDA; the full label on DailyMed
Is there a generic for acetaminophen and aspirin and caffeine (Excedrin)?
The FDA approved the first generic acetaminophen and aspirin and caffeine on November 26, 2001. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists acetaminophen and aspirin and caffeine from 39 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2001 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acetaminophen and aspirin and caffeine (Excedrin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0648 per unit (Migraine 250-250-65 mg cplt), down 6% from $0.0691 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Migraine 250-250-65 mg cplt (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Aspirin-acetaminophen-caffeine tablet | Generic | $0.0648 per tablet | $1.94 | n/a |
| Ft migraine 250-250-65 mg cplt | Generic | $0.0648 per unit | n/a | -6% |
| Gnp headache relief caplet | Generic | $0.0648 per unit | n/a | -6% |
| Gs migraine 250-250-65 mg cplt | Generic | $0.0648 per unit | n/a | -6% |
| Headache relief caplet | Generic | $0.0648 per unit | n/a | -6% |
| Headache rlf 250-250-65 mg cplt | Generic | $0.0648 per unit | n/a | -6% |
| Migraine 250-250-65 mg cplt | Generic | $0.0648 per unit | n/a | -6% |
| Migraine 250-250-65 mg geltab | Generic | $0.0648 per unit | n/a | -6% |
| Migraine formula caplet | Generic | $0.0648 per unit | n/a | -6% |
| Pain reliever pls 250-250-65 mg | Generic | $0.0648 per unit | n/a | -6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has acetaminophen and aspirin and caffeine been recalled?
The FDA's Enforcement Report lists 3 recalls naming acetaminophen and aspirin and caffeine since 2013: 1 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 11, 2024 | Class I | Aurobindo Pharma USA Inc | Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for acetaminophen and aspirin and caffeine?
The FDA Adverse Event Reporting System holds 21,416 reports that list acetaminophen and aspirin and caffeine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 340 are coded as a death and 2,119 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as acetaminophen and aspirin and caffeine?
18 other medicines are given the same way (oral) and in the same FDA class as acetaminophen and aspirin and caffeine or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Pain, Cough and cold, Fever | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Pain, Cough and cold, Fever | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Pain | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Pain | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Meloxicam | Pain | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Pain | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Ketorolac | Pain | 33 labelers | $0.164 per tablet 10 mg tablet | In shortage |
| Ibuprofen and pseudoephedrine | Cough and cold | 9 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as acetaminophen and aspirin and caffeine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to acetaminophen and aspirin and caffeine
- 18 medicines for the same use
- Other stimulants
- the pharmacologic class, with prices and generics
- Acetaminophen and aspirin and caffeine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other