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Acetaminophen

Acetaminophen is a pain reliever and fever reducer used for minor aches and pains (like headache, backache, toothache, muscle aches, cold aches and menstrual cramps) and to reduce fever.

Brand names ActaminFeverallPanadolTempra QuickletsTylenol +11 more
Rx/OTC Forms 12
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1,084 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 4, 2026 🚨Class I recall on record · 6
Other forms & routes:
Acetaminophen at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Acetaminophen (Tylenol) is a pain reliever and fever reducer for aches like headache, toothache and cramps, thought to work in the brain and spinal cord, and it is the usual first choice for minor pain and fever, a household staple for decades and widely available as a generic. At labeled amounts it is well tolerated and easy on the stomach, so most people notice nothing beyond occasional nausea. The danger is liver damage from taking too much, usually from doubling up on cold, flu or prescription products that also contain it, the risk behind the injection's boxed warning. Stop it and get medical help for any rash, blistering or facial swelling.

Clinical pearls

  • On prescription labels acetaminophen is often shortened to APAP, and many prescription pain medicines combine it with an opioid.
  • For children's liquids, shake well, dose by weight, and use only the dosing device packaged with that product.
  • Regular use at high daily amounts can raise INR (the warfarin blood test), so tell whoever manages your warfarin.
  • Having three or more alcoholic drinks every day while taking acetaminophen raises the risk of liver damage.
How you get itPrescription and over the counter
Comes asTablet, Oral suspension, Extended-release tablet +9
Earliest FDA record1982
Companies listing it with the FDA244
FDA label last updatedNov 13, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Acetaminophen, written from its FDA label.

What Acetaminophen is used for

▾

Acetaminophen products by mouth are used for these purposes:

  • Temporary relief of minor aches and pains from the common cold
  • Headache
  • Backache
  • Minor pain of arthritis
  • Toothache
  • Muscle aches
  • Premenstrual and menstrual cramps
  • Sore throat pain (Robitussin Direct Sore Throat Pain tablets)
  • Temporarily reducing fever

How Acetaminophen works

▾

The exact way acetaminophen relieves pain and lowers fever isn't established. It is thought to work mainly through actions in the central nervous system.

Acetaminophen dosage

▾

Acetaminophen is generally taken by mouth as tablets or liquid, or given by vein infusion in a medical setting. Children's liquids are dosed by weight (or age if weight is unknown) with the dosing device in the box.

  • Shake liquids well before each use.
  • The children's liquid labels allow repeat doses every 4 hours while symptoms last, no more than 5 times in 24 hours.
  • Some labels say not to give for more than 5 days unless a doctor directs.

Follow your prescriber and the label.

Dosing details from the FDA-approved label

From the Acetaminophen prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Weight under 24 lbs / under 2 years
    • Ask a doctor
  • Weight 24-35 lbs / age 2-3 years
    • 5 mL
    • Repeat dose every 4 hours while symptoms last (or as directed by a doctor)
    • Maximum: do not give more than 5 times in 24 hours
    • if possible, use weight to dose; otherwise, use age
  • Weight 36-47 lbs / age 4-5 years
    • 7.5 mL
    • Repeat dose every 4 hours while symptoms last (or as directed by a doctor)
    • Maximum: do not give more than 5 times in 24 hours
    • if possible, use weight to dose; otherwise, use age
  • Weight 48-59 lbs / age 6-8 years
    • 10 mL
    • Repeat dose every 4 hours while symptoms last (or as directed by a doctor)
    • Maximum: do not give more than 5 times in 24 hours
    • if possible, use weight to dose; otherwise, use age
  • Weight 60-71 lbs / age 9-10 years
    • 12.5 mL
    • Repeat dose every 4 hours while symptoms last (or as directed by a doctor)
    • Maximum: do not give more than 5 times in 24 hours
    • if possible, use weight to dose; otherwise, use age
  • Weight 72-95 lbs / age 11 years
    • 15 mL
    • Repeat dose every 4 hours while symptoms last (or as directed by a doctor)
    • Maximum: do not give more than 5 times in 24 hours
    • if possible, use weight to dose; otherwise, use age
Read the label’s full dosing text

Directions this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning ) chew or crush tablets completely before swallowing; do not swallow tablets whole find right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 1 tablet 36-47 lbs 4-5 years 1½ tablets 48-59 lbs 6-8 years 2 tablets 60-71 lbs 9-10 years 2½ tablets 72-95 lbs 11 years 3 tablets

Directions this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning ) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child's dose into the dosing cup repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Read the full Dosage and Administration section on DailyMed →

Acetaminophen side effects

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The injection label lists these as the most common side effects:

Common side effects

  • Nausea
  • Vomiting
  • Headache
  • Trouble sleeping (insomnia) in adults
  • Constipation in children
  • Itching in children

When to get medical help

  • Stop and get medical help right away if you get skin reddening, blisters or a rash. These can be signs of a severe skin reaction.
  • Seek emergency care for swelling of the face, mouth or throat, trouble breathing, hives or itching. These can be signs of a severe allergic reaction.
  • Call Poison Control (1-800-222-1222) or get medical help right away after any overdose, even if you feel fine.
  • Stop use and ask a doctor if pain gets worse or lasts more than 10 days.
  • Stop use and ask a doctor if fever gets worse or lasts more than 3 days.
  • Stop use and ask a doctor if new symptoms, redness or swelling appear.

Rarely, serious skin reactions or allergic reactions occur, and liver injury can result from overdose. Seek help right away for rash, blisters, facial swelling or trouble breathing.

Acetaminophen warnings and precautions

▾
  • Liver injury from exceeding the maximum daily amount, including from several acetaminophen-containing products.
  • Serious skin reactions (such as SJS and TEN, which can be fatal) and allergic reactions, including anaphylaxis.
  • Extra caution with liver disease, alcoholism, chronic malnutrition, severe dehydration or blood loss, and severe kidney disease.
  • Injection: dosing errors can cause accidental overdose and death.
  • Stop and ask a doctor if pain lasts more than 10 days or fever lasts more than 3 days.

Acetaminophen interactions

▾

These are the main things to watch for with acetaminophen:

  • Other acetaminophen products: doubling up raises the risk of liver damage.
  • Warfarin: regular high daily use raised INR in some people.
  • Alcohol: 3 or more drinks daily raises liver risk.
  • CYP2E1-affecting substances: may change how acetaminophen is processed and raise liver risk.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Acetaminophen

▾
  • Don't use it if you are allergic to acetaminophen or its ingredients.
  • The injection is contraindicated in severe liver impairment or severe active liver disease.
  • Use caution with liver disease, alcoholism, malnutrition, severe dehydration, or severe kidney disease. Severe kidney disease may need longer dosing intervals and a lower daily total with the injection.
  • Ask a health professional if pregnant or breastfeeding. Acetaminophen passes into breast milk, and one report described a rash in a breastfed infant.
  • Children under 2 should only get it as a doctor directs.

Acetaminophen overdose

▾

Too much acetaminophen can cause serious, potentially fatal liver damage. Early symptoms may include nausea, vomiting, sweating and feeling unwell, and liver injury may not show for 48 to 72 hours.

Get medical help or call Poison Control at 1-800-222-1222 right away, even if you feel fine. An antidote, N-acetylcysteine, works best when given early.

What Acetaminophen does in the body

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Acetaminophen relieves pain and reduces fever. In studies of the injection and oral forms, it did not significantly affect platelet function or bleeding time, including in people with hemophilia.

How your body processes Acetaminophen

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Acetaminophen is mainly broken down by the liver. A small share is converted to a reactive byproduct, which is normally neutralized with glutathione. The metabolites leave mainly in urine, and over 90% of a dose is cleared within 24 hours.

With the injection, peak levels occur at the end of the 15-minute infusion. They are up to 70% higher than with the same oral dose, though total exposure is very similar. Adult half-life was about 2.4 hours.

How to store Acetaminophen

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store between 20-25°C (68-77°F). Protect from light. store between 20-25°C (68-77°F) do not use if carton is opened.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

155

Supplements & herbs that interact with Acetaminophen

155 supplements and herbal products have documented interactions with Acetaminophen in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 114
  • Minor · 36
Every supplement checked against Acetaminophen — ranked by severity The full interaction hub: 5 major · 114 moderate · 36 minor · every one linked to its full report. Check Acetaminophen against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Acetaminophen has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Acetaminophen nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Acetaminophen: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Acetaminophen — the kind of thing our pharmacy team would talk through with you at the counter.

What is acetaminophen for?

▾
It temporarily relieves minor aches and pains, like headache, backache, toothache, muscle aches, cold aches, minor arthritis pain and menstrual cramps. It also reduces fever.

How much can I take safely?

▾
Follow your product label or prescriber exactly and never exceed the maximum daily amount. Remember that the limit counts every product with acetaminophen. Too much can seriously damage your liver.

Can I take it with my cold medicine?

▾
Check the label first. Many combination products also contain acetaminophen, and you shouldn't use two together. If you aren't sure, ask me or your pharmacist.

Is it okay with alcohol or warfarin?

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Having 3 or more alcoholic drinks every day while using it raises the risk of liver damage. If you take warfarin, talk with your doctor or pharmacist first, since regular high daily use raised INR in some people.

When should I stop and call a doctor?

▾
Stop and get help right away for a skin rash, blisters, or swelling of the face, mouth or throat. Also check in if pain lasts more than 10 days, fever lasts more than 3 days, or new symptoms, redness or swelling appear.

Can I use it if I'm pregnant or breastfeeding?

▾
Ask your healthcare provider first. Studies in pregnancy haven't shown a clear link to birth defects, but they have limits. Acetaminophen does pass into breast milk.

Is Acetaminophen available over the counter?

▾
Both. Some Acetaminophen products are sold over the counter and others need a prescription. According to their FDA listings, the tablet, oral suspension, extended-release tablet, oral solution, chewable tablet and capsule forms are sold over the counter and the injection form needs a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Acetaminophen first available?

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The earliest FDA record we hold for Acetaminophen is from 1982: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Acetaminophen was first used.

Who makes Acetaminophen?

▾
244 companies currently list Acetaminophen products in the FDA's NDC Directory, including Kenvue Brands LLC, Aurohealth LLC, CVS Pharmacy. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Acetaminophen on HelloPharmacist

Detailed data & references for Acetaminophen Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Acetaminophen forms and strengths (how it comes)

Acetaminophen is available in 12 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Panadol Pharbetol Tylenol
Available strengths 5 strengths
1,061 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Available strengths 1 strength
209 FDA-listed product records ⓘ

Oral solution

By mouth
Brands MAX relief junior
How this form is used
What it may be used for
  • MAX relief junior: the label lists directions only, without a stated use.
Important instructions
  • MAX relief junior: shake well before using.
  • MAX relief junior: choose the dose by weight if possible, otherwise by age. Ask a doctor for children under 2.
  • MAX relief junior: use only the enclosed dosing cup, not any other device.
  • MAX relief junior: repeat every 4 hours if needed, no more than 5 times in 24 hours or for more than 5 days unless a doctor directs.
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
135 FDA-listed product records ⓘ

Chewable tablet

By mouth
Available strengths 2 strengths
134 FDA-listed product records ⓘ

Injection

Into a vein
Available strengths 2 strengths
49 FDA-listed product records ⓘ

Capsule

By mouth
Brands Mapap
Available strengths 3 strengths
36 FDA-listed product records ⓘ

Rectal suppository

Rectal
Brands Feverall
Available strengths 4 strengths
27 FDA-listed product records ⓘ

Oral powder

By mouth
Available strengths 2 strengths
9 FDA-listed product records ⓘ

Topical cream, ointment or gel

By mouth
Available strengths 2 strengths
5 FDA-listed product records ⓘ

Orally disintegrating tablet

By mouth
Available strengths 1 strength
3 FDA-listed product records ⓘ

Other oral form

By mouth
Available strengths 1 strength
2 FDA-listed product records ⓘ

Acetaminophen on the U.S. market: products, makers and brands

How Acetaminophen appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

244 companies list 1,071 Acetaminophen product records with the FDA, mostly as tablet, oral suspension, extended-release tablet; the earliest marketing or approval year on record is 1982. Brand names on the directory include Actamin, Feverall, Panadol and 13 more; the rest are generics.

12
Dose forms ⓘ
244
Labelers (makers, repackagers, distributors)
40
Brand names
1,071
FDA-listed product records ⓘ
1982
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (94) · Kit (16) · Granule (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Kenvue Brands LLC4%
Aurohealth LLC2%
CVS Pharmacy2%
Unifirst First Aid Corporation2%
Bryant Ranch Prepack2%
Meijer Distribution Inc2%
Other makers86%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Acetaminophen is used (Medicaid data)

A general measure of how commonly Acetaminophen is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Acetaminophen is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

7,225,940
Medicaid prescriptions filled (Q1–Q4 2025)
$77.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Acetaminophen prescribed? Of the 1,601 medications we measure, Acetaminophen ranks #20 by Medicaid prescriptions — more than 99% of them.

Where Acetaminophen ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Acetaminophen product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 500 mg oral tablet is the most-dispensed Acetaminophen product — about 40% of these Medicaid prescriptions.

acetaminophen 500 MG Oral Tablet Most dispensed

2,878,919 Medicaid prescriptions (Q1–Q4 2025) 40% of Acetaminophen prescriptions shown $22.7M gross reimbursement (before rebates) ≈ $7.87 per prescription (gross)

Summed across the 54 of 1,369 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198440

acetaminophen 32 MG/ML Oral Solution

1,571,101 Medicaid prescriptions (Q1–Q4 2025) 22% of Acetaminophen prescriptions shown $11.6M gross reimbursement (before rebates) ≈ $7.41 per prescription (gross)

Summed across the 22 of 158 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 307675

acetaminophen 325 MG Oral Tablet

1,397,099 Medicaid prescriptions (Q1–Q4 2025) 19% of Acetaminophen prescriptions shown $16.4M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 12 of 316 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313782

acetaminophen 32 MG/ML Oral Suspension

593,867 Medicaid prescriptions (Q1–Q4 2025) 8% of Acetaminophen prescriptions shown $8.9M gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 36 of 513 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 307668

8 HR acetaminophen 650 MG Extended Release Oral Tablet

486,495 Medicaid prescriptions (Q1–Q4 2025) 7% of Acetaminophen prescriptions shown $5.1M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 14 of 363 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1148399

100 ML acetaminophen 10 MG/ML Injection

172,547 Medicaid prescriptions (Q1–Q4 2025) 2% of Acetaminophen prescriptions shown $11.4M gross reimbursement (before rebates) ≈ $66 per prescription (gross)

Summed across the 14 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 483017

acetaminophen 500 MG Oral Capsule

51,166 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetaminophen prescriptions shown $242,135 gross reimbursement (before rebates) ≈ $4.73 per prescription (gross)

Summed across the 1 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198439

acetaminophen 120 MG Rectal Suppository

40,953 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetaminophen prescriptions shown $490,091 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 5 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198434

acetaminophen 160 MG Chewable Tablet

6,936 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetaminophen prescriptions shown $230,917 gross reimbursement (before rebates) ≈ $33 per prescription (gross)

Summed across the 5 of 62 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313820

acetaminophen 80 MG Rectal Suppository

6,782 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetaminophen prescriptions shown $152,773 gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198445

acetaminophen 325 MG Rectal Suppository

6,745 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetaminophen prescriptions shown $154,952 gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198437

acetaminophen 650 MG Rectal Suppository

6,732 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetaminophen prescriptions shown $81,272 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 4 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198443

50 ML acetaminophen 10 MG/ML Injection

2,298 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetaminophen prescriptions shown $47,357 gross reimbursement (before rebates) ≈ $21 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2480095

acetaminophen 80 MG Chewable Tablet

2,287 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetaminophen prescriptions shown $248,423 gross reimbursement (before rebates) ≈ $109 per prescription (gross)

Summed across the 1 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 307696

acetaminophen 33.3 MG/ML Oral Solution

464 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetaminophen prescriptions shown $6,111 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 2 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 307684

65 ML acetaminophen 10 MG/ML Injection

16 Medicaid prescriptions (Q3–Q4 2025) <1% of Acetaminophen prescriptions shown $697 gross reimbursement (before rebates) ≈ $44 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2715604

Other Acetaminophen products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

1,533 Medicaid prescriptions (Q1–Q4 2025) <1% of Acetaminophen prescriptions shown $13,938 gross reimbursement (before rebates) ≈ $9.09 per prescription (gross)

Summed across the 1 of 867 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Acetaminophen, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 177 of 3,804 listed Acetaminophen NDCs with Medicaid activity.

Compare Acetaminophen products

A representative set of FDA-listed product records for Acetaminophen — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 113 of 1,071 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1,071 Acetaminophen NDCs →

Acetaminophen recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 11 Acetaminophen recalls since July 2021, covering 29 product listings. Six of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Oct 21, 2025 · Kenvue Brands LLC
Defective Container
  • TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04. Lots: Lot: EJA022, expiry: 04/30/2028 FDA record D-0121-2026 →
Ongoing Class II Aug 20, 2025 · Baxter Healthcare Corporation
Discoloration
  • Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60. Lots: Lot #: 24A27G66, Exp 12/31/2025 FDA record D-0596-2025 →
Ongoing Class II May 22, 2025 · Aurobindo Pharma USA Inc
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
  • Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10 Lots: Lot#: AEF124004A, Exp date 08/31/2026 FDA record D-0471-2025 →
Ongoing Class I Jul 8, 2024 · 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 per 100 mL (10 mg/mL)
  • Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceu… Lots: Lot #24070381; Exp. 09/30/2025 FDA record D-0635-2024 →
Ongoing Class II May 20, 2024 · Contract Pharmacal Corporation
Discoloration: Brownish tablets
  • Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 30904673… Lots: Lot#: 368638; Exp. 05/2025 FDA record D-0566-2024 →
Ongoing Class II Nov 13, 2023 · KINDER FARMS LLC
Failed Impurities/Degradation Specifications
  • KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02… Lots: Lot #: CJ70902, Exp: 07/2024; CJ76275, WJ81412, Exp: 08/2024; WK02194, WK02196, WK04141, WK02873, WK05542, Exp: 10/2024; WK02874, WK04794, Exp: 01/2025; WK04793, WK06535, Exp: 03/2025. FDA record D-0143-2024 →
  • KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04,… Lots: Lot: CJ70900, CJ76796, Exp: 8/2024; CJ77051, Exp: 09/2024; WK02998, WK02997, WK04390, WK02999, Exp: 10/2024; WK03716, Exp:12/2024; WK05150, WK05151, WK07174, Exp:02/2025; WK05539, WK06534, Exp: 03/2025; WK10259, WK23040, Exp: 04/2025; WK27… FDA record D-0142-2024 →
Class I Jun 21, 2024 · Terminated · A-S Medication Solutions LLC
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 tablets.
  • Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2 Lots: Lot: 4138197; Exp 10/31/2025 FDA record D-0631-2024 →
Class II May 22, 2023 · Completed · Aurobindo Pharma USA Inc.
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
  • Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35. Lots: Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023 FDA record D-0765-2023 →
Class II Aug 4, 2022 · Terminated · Baxter Healthcare Corporation
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
  • Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC… Lots: Lots: 20K19G64T1, Exp 10/31/2022; 21K23G65, 21K25G65, 21K26G65, 21K29G67, Exp 10/31/2023; 21L10G65, 21L13G66, 21L14G66, 21L15G65, Exp 11/30/2023 FDA record D-1348-2022 →
Class II Nov 1, 2021 · Terminated · Precision Dose Inc.
cGMP Deviations: Product manufactured with contaminated raw ingredient.
  • Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-… Lots: Lot#: 503679, 503693, 503715 FDA record D-0095-2022 →
  • Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count ca… Lots: Lot#: 503670 FDA record D-0094-2022 →
Class II Oct 26, 2021 · Terminated · Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
  • Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-26 Lots: Batch: 1CK0963, Exp 12/31/2022 FDA record D-0602-2022 →
  • Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 11673-105-26 Lots: Batch: 1CK0998, Exp 01/31/2023 FDA record D-0601-2022 →
  • Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack, Distributed by Walmart Inc., Bentonville, AR 72716. NDC: 49035-313-26 Lots: Batch: 1BK0794, Exp 12/31/2022, 1BK1035, Exp 01/31/2023 FDA record D-0599-2022 →
  • Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16 Lots: Batches: 1FK1027, 1FK1184, 1EK1046, Exp 02/28/2023 FDA record D-0598-2022 →
  • Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16 Lots: Batch: 1CK1274, Exp 02/28/2023 FDA record D-0597-2022 →
  • Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16 Lots: Batch: 1CK1274, Exp 02/28/2023 FDA record D-0596-2022 →
  • Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16 Lots: Batch: 1CK1274, Exp 02/28/2023 FDA record D-0595-2022 →
  • Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walmart, Inc., Bentonville, AR 72716. NDC: 49035-042-26 Lots: Batch: 1BK0962, Exp 12/31/2022, 1CK0999, Exp 01/31/2023 FDA record D-0592-2022 →
  • and 9 more product listings in this recall (17 in all)

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Acetaminophen RxCUI 161 13 dose forms · 55 strengths
  1. Dose form (SCDF) Chewable Tablet RxCUI 370510 In current FDA listings
    Clinical drug / strength (SCD) 80 MG RxCUI 307696 160 MG RxCUI 313820 250 MG RxCUI 2683419 325 MG RxCUI 2264779 500 MG RxCUI 665056
  2. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 370744 In current FDA listings
    Clinical drug / strength (SCD) 80 MG RxCUI 251374 160 MG RxCUI 477282 250 MG RxCUI 388081 325 MG RxCUI 603136
  3. Dose form (SCDF) Effervescent Oral Tablet RxCUI 1536879 In current FDA listings
    Clinical drug / strength (SCD) 500 MG RxCUI 1536880
  4. Dose form (SCDF) Extended Release Oral Tablet RxCUI 370512 In current FDA listings
    Clinical drug / strength (SCD) 8 HR acetaminophen 650 MG RxCUI 1148399
  5. Dose form (SCDF) Granules for Oral Solution RxCUI 2668205 In current FDA listings
    Clinical drug / strength (SCD) 500 MG RxCUI 2668206
  6. Dose form (SCDF) Oral Capsule RxCUI 370511 In current FDA listings
    Clinical drug / strength (SCD) 80 MG RxCUI 307695 160 MG RxCUI 307667 325 MG RxCUI 198436 500 MG RxCUI 198439
  7. Dose form (SCDF) Oral Film RxCUI 2705807 No current FDA listing
    Clinical drug / strength (SCD) 80 MG RxCUI 2705808
  8. Dose form (SCDF) Oral Powder RxCUI 2178754 In current FDA listings
    Clinical drug / strength (SCD) 160 MG RxCUI 2178755 500 MG RxCUI 2374360
  9. Dose form (SCDF) Oral Solution RxCUI 370506 In current FDA listings
    Clinical drug / strength (SCD) 16 MG/ML RxCUI 204900 16.7 MG/ML RxCUI 1661683 24 MG/ML RxCUI 104906 32 MG/ML RxCUI 307675 33.3 MG/ML RxCUI 307684 45 MG/ML RxCUI 2719840 48.2 MG/ML RxCUI 392293 50 MG/ML RxCUI 248316 100 MG/ML RxCUI 238159 120 MG/ML RxCUI 425723
  10. Dose form (SCDF) Oral Suspension RxCUI 370509 In current FDA listings
    Clinical drug / strength (SCD) 20 MG/ML RxCUI 437160 24 MG/ML RxCUI 250650 25 MG/ML RxCUI 422626 32 MG/ML RxCUI 307668 50 MG/ML RxCUI 250649 100 MG/ML RxCUI 243675
  11. Dose form (SCDF) Oral Tablet RxCUI 369097 In current FDA listings
    Clinical drug / strength (SCD) 160 MG RxCUI 282464 300 MG RxCUI 348978 325 MG RxCUI 313782 500 MG RxCUI 198440 650 MG RxCUI 198444 1000 MG RxCUI 430837
  12. Dose form (SCDF) Rectal Suppository RxCUI 370508 In current FDA listings
    Clinical drug / strength (SCD) 60 MG RxCUI 226882 80 MG RxCUI 198445 100 MG RxCUI 421071 120 MG RxCUI 198434 125 MG RxCUI 307666 240 MG RxCUI 152620 250 MG RxCUI 249875 300 MG RxCUI 251698 325 MG RxCUI 198437 500 MG RxCUI 250651 650 MG RxCUI 198443

Look up RxCUI 161 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Acetaminophen brand names

Acetaminophen is sold under 16 brand names in the FDA directory — Actamin, Feverall, Panadol, Tempra Quicklets and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Actamin Feverall Panadol Tempra Quicklets Tylenol Bactimicina CounterAct Pain Nortemp Ringl Mapap Pharbetol Little Fevers Cetafen Acephen Tycolene Redutemp

Who makes Acetaminophen: manufacturers and labelers

244 companies list Acetaminophen products with the FDA. By number of product records, the largest are Kenvue Brands LLC, Aurohealth LLC, CVS Pharmacy. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Kenvue Brands LLC 40 Aurohealth LLC 24 CVS Pharmacy 22 Unifirst First Aid Corporation 22 Bryant Ranch Prepack 21 Meijer Distribution Inc 20 Topco Associates LLC 20 Walgreens 20 Amazon.com Services LLC 19 Kroger Company 18 Major Pharmaceuticals 18 Wal-Mart Stores Inc 18 Walgreen Company 17 Strategic Sourcing Services LLC 16 Amerisource Bergen 15 Chain Drug Marketing Association Inc 15 Cvs Pharmacy, Inc 15 H E B 14 L. Perrigo Company 14 Walmart Inc. 14 A-S Medication Solutions 13 Proficient Rx LP 13 Rite Aid Corporation 13 Target Corporation 13

…and 220 more on the FDA NDC directory.

Acetaminophen drug class (RxNorm)

Acetaminophen belongs to the Anilides class.

Drug family (ATC) Anilides

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Acetaminophen page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 13, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Acetaminophen.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Acetaminophen after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1,084
Finished products in the current FDA directory
1,071
Companies listing them (makers, repackagers, distributors)
244
FDA labeler codes behind them ⓘ
222
Linked representative label ⓘ
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Linked label effective
Nov 13, 2024
Composite sections available
12
Linked SPL Set ID
3af22fc8-e4e0-4863-8696-6bc1257047cb
Linked SPL Document ID
26c62e88-08c4-1113-e063-6394a90ac1f8
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →