Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Topcare Ibuprofen PM (diphenhydramine citrate and ibuprofen)
Topco Associates LLC · tablet, film coated · NDC 36800-050
Listed in the FDA National Drug Code directory
Topcare Ibuprofen PM is an over-the-counter medicine made available by Topco Associates LLC, on the U.S. market since February 2009. It is marketed under an FDA approval (ANDA ANDA079113), 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 Apr 21, 2025). 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: Topcare Ibuprofen PM diphenhydramine citrate and ibuprofen DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 ALUMINUM LAKE GLYCERYL DIBEHENATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED TALC TITANIUM DIOXIDE tablet L050
Text on the package panel: Principal Display Panel TopCare ® health COMPARE TO ADVIL ® PM ACTIVE INGREDIENTS NIGHTTIME Ibuprofen PM IBUPROFEN & DIPHENHYDRAMINE CITRATE TABLETS, 200 mg / 38 mg PAIN RELIEVER (NSAID) • NIGHTTIME SLEEP-AID 20 COATED CAPLETS** **Capsule-Shaped Tablets actual size topcare-ibuprofen-pm-carton-image.jpg
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 n…
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 36800-050. 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
Topcare Ibuprofen PM
Generic name
diphenhydramine citrate and ibuprofen
Company
Topco Associates LLC
Form
tablet, film coated
Route
oral
Type
HUMAN OTC DRUG
Category
ANDA
Listing valid to
Dec 31, 2027
Product NDC
36800-050
Active ingredients
Diphenhydramine Citrate
38 mg/1
Ibuprofen
200 mg/1
Packages (3)
The last part of the NDC identifies the pack size. Your box should show one of these.
36800-050-27 1 bottle in 1 carton (36800-050-27) / 80 tablet, film coated in 1 bottle
36800-050-58 1 bottle in 1 carton (36800-050-58) / 40 tablet, film coated in 1 bottle
36800-050-60 1 bottle in 1 carton (36800-050-60) / 20 tablet, film coated in 1 bottle
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.