Ibuprofen and Diphenhydramine Citrate (Ibuprofen and Diphenhydramine Citrate)
Dr. Reddy's Laboratories Limited · tablet · NDC 55111-565
Ibuprofen and Diphenhydramine Citrate is an over-the-counter medicine made available by Dr. Reddy's Laboratories Limited, on the U.S. market since January 2010. It is marketed under an FDA approval (ANDA ANDA090619), 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 Dec 5, 2018). 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: Ibuprofen and Diphenhydramine Citrate Ibuprofen and Diphenhydramine Citrate Ibuprofen Ibuprofen Diphenhydramine Citrate Diphenhydramine carnauba wax STARCH, CORN Silicon Dioxide croscarmellose sodium FD&C blue no. 2 CELLULOSE, MICROCRYSTALLINE hypromelloses polydextrose polyethylene glycol 400 sodium lauryl sulfate stearic acid titanium dioxide blue slightly glossy smooth blue film coated RDY;565 container carton
Text on the package panel: PRINCIPAL DISPLAY PANEL Container:
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 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 an NSAID [aspirin, ibuprofen, naproxen, or ot…
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 55111-565. Recalls are listed in FDA enforcement reports from 2004 onward.
Show as table
| Item | Value (reports) |
|---|---|
| Drug ineffective | 2,823 |
| Pain | 1,964 |
| Nausea | 1,806 |
| Headache | 1,740 |
| Fatigue | 1,423 |
| Dizziness | 1,227 |
| Vomiting | 1,092 |
| Anxiety | 1,072 |
| Drug hypersensitivity | 1,047 |
| Diarrhoea | 939 |
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 (8)
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.