Prescription and over-the-counter medicine

Acetaminophen Brand names: Feverall, Tylenol; first approved as Neopap

Acetaminophen (Tylenol) is a prescription and over-the-counter medicine with an FDA approval on record since 1968. FDA's NDC Directory lists it from 89 generic labelers, and pharmacies paid $0.0339 per unit (Acetaminophen 500 mg caplet) in the October 7, 2026 NADAC survey.

Generic listed
Boxed warning

Check it at the source: the acetaminophen FDA label on DailyMed (effective November 13, 2024, Kenvue Brands LLC); the NDA 16401 record on Drugs@FDA; every acetaminophen label on DailyMed.

Highlights of the record

FDA label of November 13, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

RISK OF MEDICATION ERRORS AND HEPATOTOXICITY.

Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that: the dose in milligrams (mg) and milliliters (mL) is not confused; the dosing is based on weight for patients under 50 kg; infusion pumps are properly programmed; and the total daily dose of acetaminophen from all sources does not exceed maximum daily limits. Acetaminophen Injection contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than one acetaminophen-containing product [see Warnings and Precautions ( 5.1 ) ]. WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY See full prescribing information for complete boxed warning. Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. ( 5.3 ) Acetaminophen Injection contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. […]

This box is printed on the prescription label of acetaminophen; the over-the-counter label quoted on this page has none.

Used for

From the label: indications and usage
temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

Forms and strengths

80 mg
120 mg
325 mg
650 mg
10 mg/ml
1000 mg/100ml

Extended-release tablet; film-coated extended-release tablet; injection (solution); tablet; suppository.

On the market

Earliest approval on file: November 7, 1968 Neopap, Polymedica; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 26 first December 1, 1986; 17 with a marketed status in Drugs@FDA
Labelers listed (NDC): 93 of which 89 under generic applications, 6 under brand applications, repackagers included; 180 more under the over-the-counter monograph, without an application
Last listed patent: March 11, 2032 Ofirmev injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $0.0339 per unit Acetaminophen 500 mg caplet
Shortage (FDA): No current entry
Recalls by its makers (FDA): 19 since 2013 3 Class I among all firms' recalls; latest August 20, 2025; 30 more by firms not listed as its makers
FAERS reports: 445,075 through July 30, 2026

What is acetaminophen used for?

From the label: indications and usage
temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

Conditions named in the indications of acetaminophen's FDA labels, with every medicine labeled for each:

From other acetaminophen labels
Fever: Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

Source: FDA drug label (Tylenol 8 HR Arthritis Pain), Kenvue Brands LLC, effective November 13, 2024 (SPL set 3af22fc8-e4e0-4863-8696-6bc1257047cb), via openFDA; the full label on DailyMed

Is there a generic for acetaminophen (Tylenol)?

The FDA approved the first generic acetaminophen on December 1, 1986. 26 generic applications are approved; 17 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 from 89 labelers under a generic (ANDA) application and from 6 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Tylenol tablets; a patent listed only for Ofirmev injection runs to March 11, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

1968 earliest approval on file
1986 first generic approved
2032 last listed patent
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 (Tylenol)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0339 per unit (Acetaminophen 500 mg caplet), up 5% from $0.0324 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.

Acetaminophen 500 mg caplet (generic)
Feverall 80 mg suppository (brand)

$0.931

$0.0272

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
8hr arthritis pain ER 650 mg	Generic	$0.0631 per unit	n/a	-6%
8hr muscle ache-pain ER 650 mg	Generic	$0.0631 per unit	n/a	n/a
Acetaminophen 1,000 mg/30 mL	Generic	$0.0192 per mL	n/a	+12%
Acetaminophen 160 mg/5 mL liquid	Generic	$0.0107 per mL	n/a	-25%
Acetaminophen 160 mg/5 mL solution	Generic	$0.0174 per mL	n/a	-22%
Acetaminophen 325 mg gelcap	Generic	$0.0233 per unit	n/a	-10%
Acetaminophen 325 mg tablet	Generic	$0.0233 per tablet	$0.700	-10%
Acetaminophen 500 mg caplet	Generic	$0.0339 per unit	n/a	+5%
Acetaminophen 500 mg gelcap	Generic	$0.0339 per unit	n/a	+5%
Acetaminophen 500 mg tablet	Generic	$0.0339 per tablet	$1.02	+5%
Acetaminophen 500 mg/15 mL liquid	Generic	$0.0192 per mL	n/a	+12%
Acetaminophen 650 mg suppos	Generic	$0.349 per unit	n/a	+4%
Acetaminophen ER 650 mg caplet	Generic	$0.0631 per unit	n/a	-6%
Acetaminophen ER 650 mg tablet	Generic	$0.0631 per tablet	$1.89	-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 been recalled?

The FDA's Enforcement Report lists 49 recalls naming acetaminophen since 2013: 3 Class I (the most serious), 42 Class II, 4 Class III; 7 still ongoing. 30 of them are by firms that FDA's NDC Directory does not list as a maker of acetaminophen and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
October 21, 2025	Class II	Kenvue Brands LLC not a listed maker	Defective Container
October 17, 2025	Class II	Aero Healthcare not a listed maker	Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. …
August 20, 2025	Class II	Baxter Healthcare Corporation	Discoloration
May 22, 2025	Class II	Aurobindo Pharma USA Inc not a listed maker	cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
December 12, 2024	Class III	Akron Pharma, Inc.	Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
July 18, 2024	Class III	Granules Consumer Health Inc.	Label mix-up: Carton incorrectly labeled.
July 8, 2024	Class I	Hikma Pharmaceuticals USA Inc.	Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg …
June 21, 2024	Class I	A-S Medication Solutions LLC not a listed maker	Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the acetaminophen label say about other medicines?

The acetaminophen label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 47 other medicines name acetaminophen. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Warfarin	drug interactions (prescription label)	… cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant.

Other labels that name acetaminophen

Check acetaminophen against other medicines

Source: FDA drug label (Tylenol 8 HR Arthritis Pain), Kenvue Brands LLC, effective November 13, 2024 (SPL set 3af22fc8-e4e0-4863-8696-6bc1257047cb), via openFDA; the full label on DailyMed

What do FAERS reports show for acetaminophen?

The FDA Adverse Event Reporting System holds 445,075 reports that list acetaminophen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 62,472 are coded as a death and 158,989 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

Drug Ineffective (a use or a product term, not a reaction)37,634
Fatigue36,344
Off Label Use (a use or a product term, not a reaction)34,858
Nausea (named in the label)31,501
Headache (a use or a product term, not a reaction)30,240
Pain (a use or a product term, not a reaction)29,612
Diarrhoea25,002
Dyspnoea24,053

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as acetaminophen?

5 other medicines are given the same way (oral) and in the same FDA class as acetaminophen or labeled mainly for the same use (fever), the same class first. Fever lists all 8 medicines labeled for it, by any route. 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
Aspirin	Pain, Cough and cold, Fever	none listed	$0.0142 per tablet 81 mg tablet	A presentation being discontinued
Meclofenamate	Pain, Fever	1 labeler	n/a	No current entry
Dextromethorphan and guaifenesin and naproxen	Fever	none listed	n/a	No current entry

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does acetaminophen compare with medicines for the same use?

17 side-by-side pages set acetaminophen beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Acetaminophen side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other