Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Diphenhydramine Citrate And Ibuprofen (diphenhydramine citrate and ibuprofen)
Haleon US Holdings LLC · tablet, coated · NDC 10158-062
Listed in the FDA National Drug Code directory
Diphenhydramine Citrate And Ibuprofen is a medicine made available by Haleon US Holdings LLC, on the U.S. market since December 2005. Its listing category is "DRUG FOR FURTHER PROCESSING". Listing is not the same as FDA approval. A listing proves the product exists; it does not prove that a particular pack is genuine, so compare yours with the official description below.
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Recalls of this product
No FDA recalls are recorded for NDC 10158-062. 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
Diphenhydramine Citrate And Ibuprofen
Generic name
diphenhydramine citrate and ibuprofen
Company
Haleon US Holdings LLC
Form
tablet, coated
Route
—
Type
DRUG FOR FURTHER PROCESSING
Category
DRUG FOR FURTHER PROCESSING
Listing valid to
Dec 31, 2026
Product NDC
10158-062
Active ingredients
Diphenhydramine Citrate
38 mg/1
Ibuprofen
200 mg/1
Packages (1)
The last part of the NDC identifies the pack size. Your box should show one of these.
10158-062-01 625000 tablet, coated in 1 drum (10158-062-01)
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.