Active substance
Phenylephrine
- SFDA 10
- US FDA 36
- Health Canada 8
- US price lines 2
- NHS prices 1
- Safety 9
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| FLERINE | 10 mg/ml | Solution for injection · Intramuscular and intravenous use | 10 Vial | SAR 186.80 | Generic · Prescription | ALPHA PHARMA INDUSTRY | Valid |
| Iphen | 10 % | Eye drops, solution · Ocular use | 20 Single Dose Container | SAR 49.00 | Generic · OTC | Jamjoom Pharmaceuticals Factory Company | Valid |
| MINIMS PHENYLEPHRINE 2.5% W-V | 2.5 % | Eye drops, solution · Ophthalmic use | 20 Single Dose Container | SAR 60.10 | Generic · OTC | CHAUVIN BAUSCH & LOMB | Valid |
| MINIMS PHENYLEPHRINE HCL 10% | 10 % | Eye drops, solution · Ophthalmic use | 20 Single Dose Container | SAR 60.10 | Generic · OTC | CHAUVIN BAUSCH & LOMB | Valid |
| MYDFRIN 2.5% DROPS | 2.5 % | Eye drops, solution · Ophthalmic use | 1 Dropper Container | SAR 9.30 | NCE · OTC | ALCON LABORATORIES | Valid |
| PHENYLEPHRINE | 50 µ/ml | Solution for injection in pre-filled syringe · Intravenous use | 10 Pre-filled syringe | SAR 453.75 | NCE · Prescription | AGUETTANT LABORATORIES | Valid |
| Phenylephrine PSI | 10 mg/ml | Solution for injection · Intramuscular use | 10 Vial | SAR 255.30 | Generic · Prescription | Pharmaceutical Solution Industries (PSI) | Valid |
| ANALUX COLIRCUSI | 0.12 % | Eye drops, solution · Ocular use | 1 Dropper Container | SAR 4.30 | Generic · OTC | ALCON CUSI | Withdrawn by MAH · Not Marketed |
| ISOPTO FRIN EYE DROPS 0.12% | 0.12 % | Eye drops, solution · Ocular use | 1 Dropper Container | SAR 7.40 | Generic · OTC | ALCON COUVREUR | Withdrawn by MAH · Not Marketed |
| RHINOFRIN | 0.25 % | Nasal drops, solution · Nasal use | 1 Dropper Container | SAR 4.75 | NCE · OTC | RIYADH PHARMA | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML); 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | HIKMA PHARMS | Prescription | 20 Dec 2012 |
| IMMPHENTIV | 0.5MG/5ML (0.1MG/ML); 1MG/10ML (0.1MG/ML) | solution · intravenous | HIKMA PHARMS | Prescription | 20 Dec 2012 |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5%; 10% | solution/drops · ophthalmic | PARAGON BIOTECK | Prescription | 21 Mar 2013 |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5%; 10% | solution/drops · ophthalmic | ALCON | Prescription | 15 Jan 2015 |
| PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | MEITHEAL | Prescription | 27 Apr 2018 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | solution · intravenous | MEITHEAL | Prescription | 27 Apr 2018 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | solution · intravenous | AMNEAL | Prescription | 5 Jul 2018 |
| PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | AMNEAL | Prescription | 19 Jul 2018 |
| PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | PH HEALTH | Prescription | 21 Dec 2018 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | solution · intravenous | FRESENIUS KABI USA | Prescription | 29 Jan 2019 |
| PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | FRESENIUS KABI USA | Prescription | 30 Jan 2019 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML); 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | SANDOZ | Prescription | 31 Jan 2019 |
| BIORPHEN | 0.5MG/5ML (0.1MG/ML) | solution · intravenous | DR REDDYS LABS SA | Prescription | 21 Oct 2019 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML); 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | SAGENT PHARMS INC | Prescription | 16 Jan 2020 |
| PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML); 10MG/ML (10MG/ML) | solution · intravenous | GLAND | Prescription | 5 Jun 2020 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML); 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | CAPLIN | Prescription | 11 Jun 2020 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML); 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | MILLA PHARMS | Prescription | 17 Jul 2020 |
| PHENYLEPHRINE HYDROCHLORIDE | 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | EUGIA PHARMA | Prescription | 13 Nov 2020 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | solution · intravenous | EUGIA PHARMA | Prescription | 7 Jan 2021 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML); 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | MANKIND PHARMA | Prescription | 30 Aug 2022 |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5% | solution/drops · ophthalmic | MANKIND PHARMA | Prescription | 29 Sep 2022 |
| PHENYLEPHRINE HYDROCHLORIDE | 10% | solution/drops · ophthalmic | MANKIND PHARMA | Prescription | 11 Jan 2023 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | solution · intravenous | AVET LIFESCIENCES | Prescription | 28 Feb 2023 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML); 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | BE PHARMS | Prescription | 26 Jun 2023 |
| PHENYLEPHRINE HYDROCHLORIDE | 10MG/ML (10MG/ML); 50MG/5ML (10MG/ML); 100MG/10ML (10MG/ML) | solution · intravenous | HAINAN POLY | Prescription | 14 Mar 2024 |
11 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| MINIMS PHENYLEPHRINE HYDROCHLORIDE | 02148447 | 2.5 % / W/V | SOLUTION · OPHTHALMIC | BAUSCH & LOMB INC |
| MINIMS PHENYLEPHRINE HYDROCHLORIDE | 02148455 | 10 % / W/V | SOLUTION · OPHTHALMIC | BAUSCH & LOMB INC |
| MYDFRIN | 00465763 | 2.5 % / W/V | SOLUTION · OPHTHALMIC | ALCON CANADA INC |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION | 02454599 | 50 MCG / ML | SOLUTION · INTRAVENOUS | LABORATOIRE AGUETTANT |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION USP | 01953583 | 10 MG / ML | LIQUID · SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION USP | 02477254 | 10 MG / ML | SOLUTION · SUBCUTANEOUS; INTRAVENOUS; INTRAMUSCULAR | MARCAN PHARMACEUTICALS INC |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 1% | 02238400 | 10 MG / 1 ML | SOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUS | OMEGA LABORATORIES LIMITED |
| PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 1% | 02479281 | 10 MG / 1 ML | SOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULAR | MONT-PHARMA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | PHENYLEPHRINE 10% EYE DROP | $5.23834 | per ML | 23 Sep 2026 |
| US NADAC | PHENYLEPHRINE 2.5% EYE DROP | $9.29238 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Phenylephrine 2.5% eye drops 0.5ml unit dose preservative free | £13.94 | 20 unit dose | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 22 Dec 2025 PHENERGAN VC W/ CODEINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Mar 2023 PHENYLEPHRINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 23 Nov 2021 ADVIL ALLERGY AND CONGESTION RELIEF — safety-related labeling change
Labeling sections changed: Warnings and Precautions - US FDA 19 Nov 2021 ADVIL CONGESTION RELIEF — safety-related labeling change
Labeling sections changed: Warnings and Precautions - US FDA 17 Apr 2020 PHENYLEPHRINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 18 Oct 2019 VAZCULEP — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 8 Dec 2017 OMIDRIA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations - EMA PRAC 14 Jan 2016 PRAC signal: Pharmacokinetic drug interaction: increased bioavailability of phenylephrine when co-administered with paracetamol
Action for MAH: update of the product information: No - EMA PRAC 10 Sep 2015 PRAC signal: Pharmacokinetic drug interaction: increased bioavailability of phenylephrine when co-administered with paracetamol
Action for MAH: update of the product information: No
Combinations containing Phenylephrine
- Chlorphenamine + phenylephrine
- Dimethindene + phenylephrine
- Ketorolac + phenylephrine
- Paracetamol + phenylephrine
- Phenylephrine + zinc sulfate
- Ascorbic acid + paracetamol + phenylephrine
- Caffeine + paracetamol + phenylephrine
- Chlorphenamine + guaifenesin + phenylephrine
- Chlorphenamine + paracetamol + phenylephrine
- Guaifenesin + paracetamol + phenylephrine
- Lidocaine + phenylephrine + tropicamide
- Chlorphenamine + codeine + ephedrine + phenylephrine
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), 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.