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.
🧬 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 →
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.
Patient information guide A plain-language walkthrough of Acetaminophen, written from its FDA label.
What Acetaminophen is used for
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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
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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
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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
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- 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
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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
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- 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
▾
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 →
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.
- Major · 5
- Moderate · 114
- Minor · 36
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.
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.
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?
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How much can I take safely?
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Can I take it with my cold medicine?
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Is it okay with alcohol or warfarin?
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When should I stop and call a doctor?
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Can I use it if I'm pregnant or breastfeeding?
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Is Acetaminophen available over the counter?
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When was Acetaminophen first available?
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Who makes Acetaminophen?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Acetaminophen on HelloPharmacist
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
Oral suspension
Extended-release tablet
Oral solution
How this form is used
- MAX relief junior: the label lists directions only, without a stated use.
- 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.
Show 1 more strength Show fewer strengths
Chewable tablet
Injection
Capsule
Rectal suppository
Oral powder
Topical cream, ointment or gel
Orally disintegrating tablet
Other oral form
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.
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.
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.
How commonly is Acetaminophen prescribed? Of the 1,601 medications we measure, Acetaminophen ranks #20 by Medicaid prescriptions — more than 99% of them.
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.
acetaminophen 500 MG Oral Tablet Most dispensed
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 500 mg | Oral | Allegiant Health | OTC MONOGRAPH DRUG | View NDC → |
| 325 mg | Oral | Belmora LLC | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | CVS Pharmacy × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Cvs Woonsocket Prescription Center, Incorporated | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Geri-Care Pharmaceutical Corp | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| 325 mg | Oral | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Kenvue Brands LLC | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Major Pharmaceuticals | OTC MONOGRAPH DRUG | View NDC → |
| 650 mg | Oral | Opmx Llc | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Pharmadel LLC | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Pinnacle RX LLC | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Shield Pharmaceuticals Corp | OTC MONOGRAPH DRUG | View label ↗ |
| 500 mg | Oral | Softgel Healthcare Pvt Ltd | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | The Kroger Co | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | The Procter & Gamble Manufacturing Company | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Walgreens × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 💊Injection | ||||
| 10 mg/mL | Intravenous | B. Braun Medical Inc. × 2 listings | NDA | View NDC → |
| 10 mg/mL | Intravenous | Baxter Healthcare Corporation × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Caplin Steriles Limited | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Civica, Inc. | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Eugia US LLC | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Fresenius Kabi USA, LLC | NDA | View NDC → |
| 10 mg/mL | Intravenous | Gland Pharma Limited × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | HF Acquisition Co LLC, DBA HealthFirst | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 1000 mg/100 mL | Intravenous | Hikma Pharmaceuticals USA Inc. | NDA | View NDC → |
| 1000 mg/100 mL | Intravenous | Mylan Institutional LLC | ANDA | View NDC → |
| 10 mg/mL | Intravenous | ProPharma Distribution | NDA | View NDC → |
| 10 mg/mL | Intravenous | Remedyrepack Inc. | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Sandoz Inc × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Solupharm Pharmazeutische Erzeugnisse GmbH | ANDA | View NDC → |
| 1000 mg/100 mL | Intravenous | Solupharm Pharmazeutische Erzeugnisse GmbH | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Somerset Therapeutics, LLC | ANDA | View NDC → |
| 10 mg/mL | Intravenous | WG Critical Care, LLC | ANDA | View NDC → |
| 💊Oral powder | ||||
| 160 mg | Oral | Kenvue Brands LLC | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg/0.95 g | Oral | Kenvue Brands LLC | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg | Oral | Walgreens Co. | OTC MONOGRAPH DRUG | View NDC → |
| 💊Oral solution | ||||
| 160 mg/5 mL | Oral | A-S Medication Solutions | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Aarna Usa Inc. × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Acetris Pharma Holdings, LLC | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg/15 mL | Oral | Advanced Rx LLC | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Akron Pharma Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 325 mg/10.15 mL | Oral | American Health Packaging | OTC MONOGRAPH DRUG | View NDC → |
| 650 mg/20.3 mL | Oral | American Health Packaging | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Atlantic Biologicals Corp. × 3 listings | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Bryant Ranch Prepack × 5 listings | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg/15 mL | Oral | CVS Pharmacy | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Discount Drug Mart | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | DLC Laboratories, Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Edwards Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg/15 mL | Oral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Genexa Inc. × 3 listings | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Genomma Lab USA, Inc. | OTC MONOGRAPH NOT FINAL | View NDC → |
| 160 mg/5 mL | Oral | Geri-Care Pharmaceuticals, Corp | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Infirst Healthcare Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Llorens Pharmaceuticals International Division | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Major Pharmaceuticals | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg/15 mL | Oral | Major Pharmaceuticals × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Marc Glassman, Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Medtech Products Inc. × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 675 mg/15 mL | Oral | Menper Distributors, Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Method Pharmaceuticals, LLC × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Oncor Pharmaceuticals | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Patrin Pharma, Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 325 mg/10.15 mL | Oral | Patrin Pharma, Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 650 mg/20.3 mL | Oral | Patrin Pharma, Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Pharmadel LLC | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Proficient Rx LP | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Rnv LLC × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 1000 mg/30 mL | Oral | The Procter & Gamble Manufacturing Company × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Verityrx, Llc | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Verityrx. Llc | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg/15 mL | Oral | Walgreens | OTC MONOGRAPH DRUG | View NDC → |
| 1000 mg/30 mL | Oral | Walmart Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 160 mg/5 mL | Oral | Westminster Pharmaceuticals, LLC | OTC MONOGRAPH DRUG | View NDC → |
| 💊Other oral form | ||||
| 250 mg | Oral | Walmart Inc × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 💊Topical cream, ointment or gel | ||||
| 80 mg | Oral | CalmCo LLC × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 0.5 g/24 g | Oral | Moremed Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Orelli Inc. | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | P & L Development, LLC | OTC MONOGRAPH DRUG | View NDC → |
| 500 mg | Oral | Walgreens | OTC MONOGRAPH DRUG | View NDC → |
| 💊Kits | ||||
| — | — | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | OTC MONOGRAPH DRUG | View NDC → |
| — | — | Family Dollar (FAMILY WELLNESS) | OTC MONOGRAPH DRUG | View NDC → |
| — | — | Harris Teeter, LLC | OTC MONOGRAPH DRUG | View NDC → |
| — | — | Kenvue Brands LLC | OTC MONOGRAPH DRUG | View NDC → |
| — | — | Safeway, Inc. | OTC MONOGRAPH DRUG | View NDC → |
| — | — | WinCo Foods, LLC | OTC MONOGRAPH DRUG | View NDC → |
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 side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Acetaminophen — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Acetaminophen in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Acetaminophen FDA approval history
How Acetaminophen went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
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.
- 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 →
- 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 →
- 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 →
- 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 →
- 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 →
- 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 →
- 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 →
- 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 →
- 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 →
- 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 →
- 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.
RxCUI 161 13 dose forms · 55 strengths
-
Dose form (SCDF) Chewable Tablet RxCUI 370510In current FDA listings -
Dose form (SCDF) Disintegrating Oral Tablet RxCUI 370744In current FDA listingsClinical drug / strength (SCD) 80 MGRxCUI 251374160 MGRxCUI 477282250 MGRxCUI 388081325 MGRxCUI 603136 -
Dose form (SCDF) Effervescent Oral Tablet RxCUI 1536879In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 1536880 -
Dose form (SCDF) Extended Release Oral Tablet RxCUI 370512In current FDA listingsClinical drug / strength (SCD) 8 HR acetaminophen 650 MGRxCUI 1148399 -
Dose form (SCDF) Granules for Oral Solution RxCUI 2668205In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 2668206 -
Dose form (SCDF) Injection RxCUI 1803956In current FDA listingsClinical drug / strength (SCD) 50 ML acetaminophen 10 MG/MLRxCUI 248009565 ML acetaminophen 10 MG/MLRxCUI 2715604100 ML acetaminophen 10 MG/MLRxCUI 483017 -
Dose form (SCDF) Oral Capsule RxCUI 370511In current FDA listings -
Dose form (SCDF) Oral Film RxCUI 2705807No current FDA listingClinical drug / strength (SCD) 80 MGRxCUI 2705808 -
Dose form (SCDF) Oral Powder RxCUI 2178754In current FDA listings -
Dose form (SCDF) Oral Solution RxCUI 370506In current FDA listingsClinical drug / strength (SCD) 16 MG/MLRxCUI 20490016.7 MG/MLRxCUI 166168324 MG/MLRxCUI 10490632 MG/MLRxCUI 30767533.3 MG/MLRxCUI 30768445 MG/MLRxCUI 271984048.2 MG/MLRxCUI 39229350 MG/MLRxCUI 248316100 MG/MLRxCUI 238159120 MG/MLRxCUI 425723 -
Dose form (SCDF) Oral Suspension RxCUI 370509In current FDA listingsClinical drug / strength (SCD) 20 MG/MLRxCUI 43716024 MG/MLRxCUI 25065025 MG/MLRxCUI 42262632 MG/MLRxCUI 30766850 MG/MLRxCUI 250649100 MG/MLRxCUI 243675 -
Dose form (SCDF) Oral Tablet RxCUI 369097In current FDA listings -
Dose form (SCDF) Rectal Suppository RxCUI 370508In current FDA listings
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 supply and shortage status
Whether Acetaminophen is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
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.
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.
…and 220 more on the FDA NDC directory.
Acetaminophen drug class (RxNorm)
Acetaminophen belongs to the Anilides class.
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.
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 →