ADVIL PM (diphenhydramine HCl, ibuprofen)
Haleon US Holdings LLC · capsule, liquid filled · NDC 0573-0148
ADVIL PM is an over-the-counter medicine made available by Haleon US Holdings LLC, on the U.S. market since January 2025. It is marketed under an FDA approval (NDA NDA021393), so the FDA has reviewed its safety, effectiveness and manufacturing. A listing proves the product exists; it does not prove that a particular pack is genuine, so compare yours with the official description below.
What the genuine product looks like
From the official FDA label (version of Jul 29, 2026). Compare the colour, shape, imprint and packaging with what you have. Any difference is a reason to ask a pharmacist before taking it.
Product data on the label: ADVIL PM diphenhydramine HCl, ibuprofen DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE WATER SORBITAN SORBITOL Clear blue Oval liqui-gel Advil;PM ADVIL PM diphenhydramine HCl, ibuprofen DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYC…
Text on the package panel: PRINCIPAL DISPLAY PANEL (Advil PM Liqui-Gels) Advil ® PM LIQUI•GELS ® Solubilized Ibuprofen, 200 mg / Diphenhydramine HCl, 25 mg Pain Reliever (NSAID) / Nighttime Sleep-Aid Actual Size 20 Liquid Filled Capsules Advil PM LiquiGels 20 capsules
What it is for
Purposes Nighttime sleep-aid Pain reliever
Key warnings
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs …
Excerpts from the FDA label. Always read the leaflet in your pack and ask a pharmacist or doctor about your own situation.
Recalls of this product
No FDA recalls are recorded for NDC 0573-0148. Recalls are listed in FDA enforcement reports from 2004 onward.
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 1,176 |
| Somnolence | 424 |
| Product use in unapproved indication | 346 |
| Drug effective for unapproved indication | 283 |
| Insomnia | 240 |
| Feeling abnormal | 220 |
| Fatigue | 182 |
| Dizziness | 177 |
| Intentional product misuse | 145 |
| Headache | 116 |
These counts are reports, not proof that the medicine caused the problem. Popular medicines get more reports simply because more people take them. They are useful for spotting what to watch for, not for comparing medicines.
Official listing
Active ingredients
Packages (2)
The last part of the NDC identifies the pack size. Your box should show one of these.
Think your pack is fake?
Stop taking it, keep the pack and receipt, and show it to a pharmacist. In the U.S., report it to FDA MedWatch; elsewhere, to your national medicines regulator. How to spot a fake medicine.
Source: openFDA (U.S. Food and Drug Administration) drug directory, labels, enforcement reports and FAERS, retrieved Nov 8, 2026. The FDA notes this data should not be relied on alone for medical decisions. Not medical advice.