Active substances
Ibuprofen + Phenylephrine
- US FDA 2
- UK MHRA 6
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ADVIL CONGESTION RELIEF | 200MG;10MG | tablet · oral | HALEON US HOLDINGS | Over-the-counter | 27 May 2010 |
| IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | tablet · oral | PERRIGO R AND D | Over-the-counter | 3 Jul 2014 |
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| CARE COLD & FLU RELIEF 200MG/5MG FILM COATED TABLETS | PL 00240/0382 | THORNTON & ROSS LIMITED | GSL |
| CARE MAX STRENGTH COLD & FLU RELIEF 400MG/10MG FILM COATED TABLETS | PL 00240/0393 | THORNTON & ROSS LIMITED | POM |
| LEMSIP MAX ALL DAY FLU RELIEF TABLETS | PL 00063/0541 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GSL |
| NUROFEN COLD & FLU RELIEF 200MG/5MG TABLETS | PL 00063/0541 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GSL |
| NUROFEN DAY & NIGHT COLD & FLU 200MG/5MG TABLETS | PL 00063/0556 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GSL |
| NUROFEN SINUS & BLOCKED NOSE 200MG/5MG TABLETS | PL 00063/0687 | RECKITT BENCKISER HEALTHCARE (UK) LIMITED | GSL |
Components
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.