Over-the-counter medicine
Diphenhydramine and ibuprofen Brand names: Advil; first approved as Advil Pm
Diphenhydramine and ibuprofen (Advil) is an over-the-counter medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 39 generic labelers, and pharmacies paid $0.131 per unit (Gs ibuprofen pm caplet) in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the diphenhydramine and ibuprofen FDA label on DailyMed (effective July 29, 2026, Haleon US Holdings LLC); the NDA 21394 record on Drugs@FDA; every diphenhydramine and ibuprofen label on DailyMed.
Highlights of the record
FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagefor relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Forms and strengths
- 25 mg / 200 mg
- 38 mg / 200 mg
- 200 mg / 25 mg
- 200 mg / 38 mg
Liquid-filled capsule; film-coated tablet; coated tablet; tablet.
On the market
- Earliest approval on file
- December 21, 2005 Advil Pm, Haleon Us Holdings; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first December 22, 2008; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 44 of which 39 under generic applications, 5 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.131 per unit Gs ibuprofen pm caplet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2014 0 Class I among all firms' recalls; latest February 26, 2014
- FAERS reports
- 23,174 through July 30, 2026
What is diphenhydramine and ibuprofen used for?
From the label: indications and usagefor relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
FDA pharmacologic class: Histamine-1 Receptor Antagonist and Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (ADVIL PM), Haleon US Holdings LLC, effective July 29, 2026 (SPL set 405afdb4-c157-1d88-f232-848063ba4714), via openFDA; the full label on DailyMed
Is there a generic for diphenhydramine and ibuprofen (Advil)?
The FDA approved the first generic diphenhydramine and ibuprofen on December 22, 2008. 7 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists diphenhydramine and ibuprofen from 39 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2005 earliest approval on file
- 2008 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for diphenhydramine and ibuprofen (Advil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.131 per unit (Gs ibuprofen pm caplet), up 3% from $0.127 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Gs ibuprofen pm caplet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft ibuprofen pm 200-38 mg cplt | Generic | $0.131 per unit | n/a | +3% |
| Gnp ibuprofen pm caplet | Generic | $0.131 per unit | n/a | +3% |
| Gs ibuprofen pm caplet | Generic | $0.131 per unit | n/a | +3% |
| Ibuprofen pm 200-38 mg caplet | Generic | $0.131 per unit | n/a | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has diphenhydramine and ibuprofen been recalled?
The FDA's Enforcement Report lists 1 recall naming diphenhydramine and ibuprofen since 2014: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 26, 2014 | Class III | Pfizer Us Pharmaceutical Group | Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the diphenhydramine and ibuprofen label say about other medicines?
The diphenhydramine and ibuprofen label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings | Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. |
| Naproxen | warnings | 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 [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this … |
Source: FDA drug label (ADVIL PM), Haleon US Holdings LLC, effective July 29, 2026 (SPL set 405afdb4-c157-1d88-f232-848063ba4714), via openFDA; the full label on DailyMed
What do FAERS reports show for diphenhydramine and ibuprofen?
The FDA Adverse Event Reporting System holds 23,174 reports that list diphenhydramine and ibuprofen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 807 are coded as a death and 5,824 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antihistamines
- the pharmacologic class, with prices and generics
- Diphenhydramine and ibuprofen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other