Quick answers
- What is Advil?
- Advil is a brand name of Ibuprofen, Diphenhydramine and ibuprofen, Acetaminophen and ibuprofen, Chlorpheniramine, ibuprofen and phenylephrine, Ibuprofen and pseudoephedrine, Ibuprofen and phenylephrine and Chlorpheniramine, ibuprofen and pseudoephedrine, an over-the-counter medicine. The FDA NDC Directory lists 59 Advil products in 15 strengths and forms.
- Who makes Advil?
- Haleon US Holdings holds the FDA application for Advil (NDA018989, approved May 18, 1984). 4 other companies (repackagers or distributors) also list Advil products.
- Is there a generic or store brand of Advil?
- Yes. The FDA NDC Directory lists 573 other products with the same active ingredients, strength and form as a Advil product, 561 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Advil been recalled?
- FDA enforcement reports list 6 recalls of Advil products; the newest started March 16, 2020. A recall usually concerns specific lots, not every product.
What Advil is
Each Advil 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.
Ibuprofen · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ibuprofen 100 mg tablet, chewable (oral) | Junior Strength Advil | 38 products, 21 companies | DailyMed |
| ibuprofen 100 mg tablet, coated (oral) | Junior Strength Advil | None listed | DailyMed |
| ibuprofen 100 mg/5 mL suspension (oral) | Childrens Advil | 155 products, 62 companies | DailyMed |
| ibuprofen 200 mg capsule, liquid filled (oral) | Advil Liqui-Gels, Advil, Advil Liquigel, Advil Migraine | 150 products, 72 companies | DailyMed |
| ibuprofen 200 mg tablet, coated (oral) | Advil | 113 products, 49 companies | DailyMed |
| ibuprofen 50 mg/1.25 mL suspension/ drops (oral) | Infants Advil | 29 products, 25 companies | DailyMed |
| ibuprofen sodium 256 mg tablet, coated (oral) | Advil, Advil Menstrual Pain | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Ibuprofen →
Diphenhydramine and ibuprofen · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| diphenhydramine citrate 38 mg · ibuprofen 200 mg tablet, coated (oral) | Advil PM | 13 products, 10 companies | DailyMed |
| diphenhydramine hydrochloride 25 mg · ibuprofen 200 mg capsule, liquid filled (oral) | Advil Pm | 20 products, 15 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Diphenhydramine and ibuprofen →
Acetaminophen and ibuprofen · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 250 mg · ibuprofen 125 mg tablet, film coated (oral) | Advil Dual Action with Acetaminophen | 48 products, 32 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen and ibuprofen →
Chlorpheniramine, ibuprofen and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| chlorpheniramine maleate 4 mg · ibuprofen 200 mg · phenylephrine hydrochloride 10 mg tablet, coated (oral) | Advil Allergy and Congestion Relief, Advil Multi-Symptom Cold and Flu | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Chlorpheniramine, ibuprofen and phenylephrine →
Ibuprofen and pseudoephedrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ibuprofen 200 mg · pseudoephedrine hydrochloride 30 mg capsule, liquid filled (oral) | Advil Cold and Sinus | 5 products, 5 companies | DailyMed |
| ibuprofen 200 mg · pseudoephedrine hydrochloride 30 mg tablet, coated (oral) | Advil Cold and Sinus | 2 products, 2 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Ibuprofen and pseudoephedrine →
Ibuprofen and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ibuprofen 200 mg · phenylephrine hydrochloride 10 mg tablet, coated (oral) | Advil Sinus Congestion and Pain Relief, Advil Sinus Congestion and Pain | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Ibuprofen and phenylephrine →
Chlorpheniramine, ibuprofen and pseudoephedrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| chlorpheniramine maleate 2 mg · ibuprofen 200 mg · pseudoephedrine hydrochloride 30 mg tablet, coated (oral) | Advil Allergy Sinus | None listed | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Chlorpheniramine, ibuprofen and pseudoephedrine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA018989 | Haleon US Holdings | May 18, 1984 | 14 |
| NDA019771 | Haleon US Holdings | September 19, 1989 | 2 |
| NDA020402 | Haleon US Holdings | April 20, 1995 | 10 |
| NDA020589 | Haleon US Holdings | June 27, 1996 | 7 |
| NDA020267 | Haleon US Holdings | December 13, 1996 | 1 |
| NDA020812 | Haleon US Holdings | January 30, 1998 | 1 |
| NDA020944 | Haleon US Holdings | December 18, 1998 | 2 |
| NDA021374 | Haleon US Holdings | May 30, 2002 | 1 |
| NDA021441 | Haleon US Holdings | December 19, 2002 | 1 |
| NDA021393 | Haleon US Holdings | December 21, 2005 | 2 |
| NDA021394 | Haleon US Holdings | December 21, 2005 | 5 |
| NDA022565 | Haleon US Holdings | May 27, 2010 | 2 |
| NDA022113 | Haleon US Holdings | December 21, 2011 | 4 |
| NDA201803 | Haleon US Holdings | June 12, 2012 | 3 |
| NDA211733 | Haleon US Holdings | February 28, 2020 | 4 |
Companies that list Advil
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Advil products.
- Haleon US Holdings LLC37 products
- Lil' Drug Store Products, Inc.11 products
- Navajo Manufacturing Company Inc.6 products
- Select Consumer Group4 products
- Proficient Rx LP1 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.
-
March 16, 2020 · Class II · Terminated · D-1068-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co — Glaxosmithkline Consumer Healthcare Holdings
-
March 16, 2020 · Class II · Terminated · D-1067-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.) — Glaxosmithkline Consumer Healthcare Holdings
-
March 16, 2020 · Class II · Terminated · D-1066-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95 — Glaxosmithkline Consumer Healthcare Holdings
-
March 16, 2020 · Class II · Terminated · D-1065-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, — Glaxosmithkline Consumer Healthcare Holdings
-
August 23, 2018 · Class II · Terminated · D-1169-2018
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0 — Pfizer Global Supply
-
February 26, 2014 · Class III · Terminated · D-1166-2014
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43 — Pfizer Us Pharmaceutical Group
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.