FDA approval · Drugs@FDA
ADVIL ALLERGY AND CONGESTION RELIEFchlorpheniramine maleate, ibuprofen, phenylephrine hydrochloride
NDA022113 ·
FDA approved the original new drug application for ADVIL ALLERGY AND CONGESTION RELIEF on December 21, 2011, sponsored by HALEON US HOLDINGS. FDA has approved 1 efficacy supplement on the application since, the most recent on April 28, 2017.
- Application
- NDA022113
- Sponsor
- HALEON US HOLDINGS
- Original approval
- Review
- standard review
- Submission class
- Type 4 - New Combination
- Active ingredient
- chlorpheniramine maleate, ibuprofen, phenylephrine hydrochloride
Browse every approval whose brand starts with A, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| chlorpheniramine maleate 4MG; ibuprofen 200MG; phenylephrine hydrochloride 10MG | TABLET | ORAL | Over-the-counter |
| chlorpheniramine maleate 4MG; ibuprofen 200MG; phenylephrine hydrochloride 10MG | TABLET | ORAL | Over-the-counter |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-1 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 7. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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