Over-the-counter medicine
Ibuprofen and phenylephrine Brand names: Advil; first approved as Advil Congestion Relief
Ibuprofen and phenylephrine (Advil) is an over-the-counter medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
- Over the counter
Check it at the source: the ibuprofen and phenylephrine FDA label on DailyMed (effective July 22, 2025, Haleon US Holdings LLC); the NDA 22565 record on Drugs@FDA; every ibuprofen and phenylephrine label on DailyMed.
Highlights of the record
FDA label of July 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagetemporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains reduces swelling of the nasal passages temporarily restores freer breathing through the nose
Forms and strengths
- 200 mg / 10 mg
Film-coated tablet; coated tablet.
On the market
- Earliest approval on file
- May 27, 2010 Advil Congestion Relief, Haleon Us Holdings; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first July 3, 2014; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 3 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,000 through July 30, 2026
What is ibuprofen and phenylephrine used for?
From the label: indications and usagetemporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains reduces swelling of the nasal passages temporarily restores freer breathing through the nose
Conditions named in the indications of ibuprofen and phenylephrine's FDA labels, with every medicine labeled for each:
From other ibuprofen and phenylephrine labelsCough and cold: Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains reduces swelling of the nasal passages temporarily restores freer breathing through …
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug and alpha-1 Adrenergic Agonist.
Source: FDA drug label (ADVIL SINUS CONGESTION AND PAIN), Haleon US Holdings LLC, effective July 22, 2025 (SPL set b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf), via openFDA; the full label on DailyMed
Is there a generic for ibuprofen and phenylephrine (Advil)?
The FDA approved the first generic ibuprofen and phenylephrine on July 3, 2014. 1 generic application is approved; 1 of it carries 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 ibuprofen and phenylephrine from 3 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2010 earliest approval on file
- 2014 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ibuprofen and phenylephrine label say about other medicines?
The ibuprofen and phenylephrine 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 SINUS CONGESTION AND PAIN), Haleon US Holdings LLC, effective July 22, 2025 (SPL set b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf), via openFDA; the full label on DailyMed
What do FAERS reports show for ibuprofen and phenylephrine?
The FDA Adverse Event Reporting System holds 1,000 reports that list ibuprofen and phenylephrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 6 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 else is labeled for the same conditions as ibuprofen and phenylephrine?
17 other medicines are given the same way (oral) and in the same FDA class as ibuprofen and phenylephrine or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Naproxen | Cough and cold | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Acetaminophen and aspirin and caffeine | Cough and cold | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Naproxen and pseudoephedrine | Cough and cold | 10 labelers | $0.244 per unit 220-120 mg | No current entry |
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Dextromethorphan and guaifenesin | Cough and cold | 61 labelers | $0.0207 per mL 200-20 mg/20 mL | No current entry |
| Guaifenesin | Cough and cold | 102 labelers | $0.284 per tablet 600 mg tablet | No current entry |
| Benzonatate | Cough and cold | 45 labelers | $0.0656 per capsule 100 mg capsule | No current entry |
| Dextromethorphan | Cough and cold | 28 labelers | $0.122 per unit 15 mg softgel | No current entry |
Every medicine labeled for the same conditions as ibuprofen and phenylephrine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ibuprofen and phenylephrine
- 17 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Ibuprofen and phenylephrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other