Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
ADVIL PM (diphenhydramine citrate and ibuprofen)
Select Consumer Group · tablet, coated · NDC 85237-1784
Listed in the FDA National Drug Code directory
ADVIL PM is an over-the-counter medicine made available by Select Consumer Group, on the U.S. market since December 2005. It is marketed under an FDA approval (NDA NDA021394), 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 May 27, 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 citrate and ibuprofen CALCIUM STEARATE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN blue Advil;PM
Text on the package panel: Principal Display Panel Advilpm-2 Advilpm-5 AdvilPM-4 Advil PM-4 Advil PM -1
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.
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Recalls of this product
No FDA recalls are recorded for NDC 85237-1784. Recalls are listed in FDA enforcement reports from 2004 onward.
Other recent recalls of diphenhydramine citrate and ibuprofen
Same active ingredient, other companies or packs. Check the company and lot number on your pack.
Drug ineffective1,177 reports
Somnolence424 reports
Product use in unapproved indication346 reports
Drug effective for unapproved indication283 reports
Insomnia244 reports
Feeling abnormal223 reports
Fatigue189 reports
Dizziness179 reports
Intentional product misuse145 reports
Headache119 reports
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 1,177 |
| Somnolence | 424 |
| Product use in unapproved indication | 346 |
| Drug effective for unapproved indication | 283 |
| Insomnia | 244 |
| Feeling abnormal | 223 |
| Fatigue | 189 |
| Dizziness | 179 |
| Intentional product misuse | 145 |
| Headache | 119 |
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
Brand
ADVIL PM
Generic name
diphenhydramine citrate and ibuprofen
Company
Select Consumer Group
Form
tablet, coated
Route
oral
Type
HUMAN OTC DRUG
Category
NDA
Listing valid to
Dec 31, 2027
Product NDC
85237-1784
Active ingredients
Diphenhydramine Citrate
38 mg/1
Ibuprofen
200 mg/1
Packages (5)
The last part of the NDC identifies the pack size. Your box should show one of these.
85237-1784-1 1 pouch in 1 container (85237-1784-1) / 2 tablet, coated in 1 pouch (85237-1784-0)
85237-1784-2 2 pouch in 1 container (85237-1784-2) / 2 tablet, coated in 1 pouch (85237-1784-0)
85237-1784-4 25 pouch in 1 carton (85237-1784-4) / 2 tablet, coated in 1 pouch (85237-1784-0)
85237-1784-5 30 pouch in 1 carton (85237-1784-5) / 2 tablet, coated in 1 pouch (85237-1784-0)
85237-1784-7 3 pouch in 1 container (85237-1784-7) / 2 tablet, coated in 1 pouch (85237-1784-0)
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.