Quick answers
- What is Tylenol?
- Tylenol is a brand name of Acetaminophen, Acetaminophen, dextromethorphan, guaifenesin and phenylephrine, Acetaminophen and diphenhydramine, Acetaminophen, guaifenesin and phenylephrine, Lidocaine, Acetaminophen, chlorpheniramine, dextromethorphan and phenylephrine, Camphor (synthetic) and menthol, Lidocaine and menthol, Acetaminophen, dextromethorphan, doxylamine and phenylephrine and Acetaminophen and phenylephrine, an over-the-counter medicine. The FDA NDC Directory lists 82 Tylenol products in 26 strengths and forms.
- Who makes Tylenol?
- Kenvue Brands LLC lists 50 of the 82 Tylenol products in the FDA NDC Directory.
- Is there a generic or store brand of Tylenol?
- Yes. The FDA NDC Directory lists 1,144 other products with the same active ingredients, strength and form as a Tylenol product, 1,144 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Tylenol been recalled?
- FDA enforcement reports list 1 recall of Tylenol products; the newest started October 21, 2025. A recall usually concerns specific lots, not every product.
What Tylenol is
Each Tylenol product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Acetaminophen · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 160 mg powder (oral) | Childrens TYLENOL | 1 product, 1 company | DailyMed |
| acetaminophen 160 mg tablet, chewable (oral) | Childrens TYLENOL | 42 products, 28 companies | DailyMed |
| acetaminophen 160 mg/5 mL suspension (oral) | Childrens TYLENOL, Infants TYLENOL, TYLENOL For Children Plus Adults | 222 products, 79 companies | DailyMed |
| acetaminophen 325 mg tablet (oral) | TYLENOL Regular Strength | 79 products, 64 companies | DailyMed |
| acetaminophen 325 mg tablet, film coated (oral) | TYLENOL Regular Strength | 12 products, 11 companies | DailyMed |
| acetaminophen 500 mg capsule, liquid filled (oral) | TYLENOL Extra Strength | 8 products, 7 companies | DailyMed |
| acetaminophen 500 mg tablet (oral) | Tylenol Extra Strength, Tylenol Extra Strength Caplet | 212 products, 106 companies | DailyMed |
| acetaminophen 500 mg tablet, coated (oral) | TYLENOL Extra Strength | 85 products, 49 companies | DailyMed |
| acetaminophen 500 mg tablet, film coated (oral) | TYLENOL Extra Strength | 83 products, 48 companies | DailyMed |
| acetaminophen 500 mg/0.95 g powder (oral) | TYLENOL Extra Strength | None listed | DailyMed |
| acetaminophen 650 mg tablet, extended release (oral) | Tylenol 8 HR Arthritis Pain | 68 products, 45 companies | DailyMed |
| acetaminophen 650 mg tablet, film coated, extended release (oral) | Tylenol 8HR, Tylenol 8 Hr Arthritis Pain, Tylenol 8 Hr Muscle Aches and Pain | 36 products, 24 companies | DailyMed |
| acetaminophen 960 mg/30 mL suspension (oral) | TYLENOL Extra Strength | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen →
Acetaminophen, dextromethorphan, guaifenesin and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 325 mg · dextromethorphan hydrobromide 10 mg · guaifenesin 200 mg · phenylephrine hydrochloride 5 mg tablet, film coated (oral) | TYLENOL Cold Plus Flu Severe, Tylenol Cold and Flu, Tylenol Cold Plus Flu Severe Severe | 45 products, 22 companies | DailyMed |
| acetaminophen 325 mg/15 mL · dextromethorphan hydrobromide 10 mg/15 mL · guaifenesin 200 mg/15 mL · phenylephrine hydrochloride 5 mg/15 mL solution (oral) | TYLENOL Cold Plus Mucus Severe | 35 products, 22 companies | DailyMed |
| acetaminophen 650 mg/30 mL · dextromethorphan hydrobromide 20 mg/30 mL · guaifenesin 400 mg/30 mL · phenylephrine hydrochloride 10 mg/30 mL solution (oral) | Tylenol Cold Plus Flu Severe | 2 products, 2 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, dextromethorphan, guaifenesin and phenylephrine →
Acetaminophen and diphenhydramine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 1000 mg/30 mL · diphenhydramine hydrochloride 50 mg/30 mL solution (oral) | TYLENOL PM Extra Strength | 4 products, 3 companies | — |
| acetaminophen 500 mg · diphenhydramine hydrochloride 25 mg tablet, film coated (oral) | Tylenol PM Extra Strength, Tylenol PM | 27 products, 20 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen and diphenhydramine →
Acetaminophen, guaifenesin and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 325 mg · guaifenesin 200 mg · phenylephrine hydrochloride 5 mg tablet, coated (oral) | Tylenol Sinus Severe | 50 products, 20 companies | DailyMed |
| acetaminophen 325 mg · guaifenesin 200 mg · phenylephrine hydrochloride 5 mg tablet, film coated (oral) | Tylenol Cold Plus Head Congestion Severe | 34 products, 18 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, guaifenesin and phenylephrine →
Lidocaine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| lidocaine 4% cream (topical) | Tylenol Precise Pain Relieving, Tylenol Precise Warming Pain Relieving | 63 products, 44 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Lidocaine →
Acetaminophen, chlorpheniramine, dextromethorphan and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 160 mg/5 mL · chlorpheniramine maleate 1 mg/5 mL · dextromethorphan hydrobromide 5 mg/5 mL · phenylephrine hydrochloride 2.5 mg/5 mL suspension (oral) | Childrens TYLENOL COLD Plus FLU | 3 products, 3 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, chlorpheniramine, dextromethorphan and phenylephrine →
Camphor (synthetic) and menthol · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| camphor (synthetic) 4% · menthol 1.25% cream (topical) | Tylenol Precise Nighttime Pain Relieving | 1 product, 1 company | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Camphor (synthetic) and menthol →
Lidocaine and menthol · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| lidocaine 4% · menthol, unspecified form 1% cream (topical) | Tylenol Precise Cooling Pain Relieving | 1 product, 1 company | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Lidocaine and menthol →
Acetaminophen, dextromethorphan, doxylamine and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 325 mg/15 mL · dextromethorphan hydrobromide 10 mg/15 mL · doxylamine succinate 6.25 mg/15 mL · phenylephrine hydrochloride 5 mg/15 mL solution (oral) | Tylenol Cold plus Flu plus Cough Night | 13 products, 12 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, dextromethorphan, doxylamine and phenylephrine →
Acetaminophen and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 325 mg · phenylephrine hydrochloride 5 mg tablet, film coated (oral) | Tylenol Sinus Plus Headache Day | 18 products, 16 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen and phenylephrine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019872 | Kenvue Brands | June 8, 1994 | 2 |
| ANDA211544 | Granules | April 16, 2019 | 2 |
Companies that list Tylenol
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tylenol products.
- Kenvue Brands LLC54 products
- Navajo Manufacturing Company Inc.4 products
- R J General Corporation4 products
- Savings Distributors LLC4 products
- Morning Star OTC4 products
- Jones Healthcare Group - Packaging Services, Inc4 products
- A-S Medication Solutions3 products
- Select Consumer Group LLC2 products
- Select Consumer Group2 products
- Lil' Drug Store Products, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 21, 2025 · Class II · Ongoing · D-0121-2026
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. — Kenvue Brands LLC
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.