Is Pseudoephedrine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Pseudoephedrine.

Is Pseudoephedrine approved by the US FDA?

Drugs@FDA lists 9 application product lines for Pseudoephedrine, including PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter); PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter); PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter); PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter); NOVAFED (Discontinued).

Are there safety signals or safety updates for Pseudoephedrine?

US FDA: 15 entries; MHRA: 1 entry (latest 2026-07-02).

Active substance

Pseudoephedrine

SFDA 1
US FDA 9
US price lines 3
NHS prices 2
Safety 16

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OTRINOL 120MG CAP	120 mg	Capsule · Oral use	10 Blister	SAR 8.45	NCE · OTC	NOVARTIS	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	tablet, extended release · oral	L PERRIGO CO	Over-the-counter	26 Feb 1999
PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	tablet, extended release · oral	SUN PHARM INDS LTD	Over-the-counter	28 Sep 2005
PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	tablet, extended release · oral	AUROBINDO PHARMA	Over-the-counter	9 Jun 2017
PSEUDOEPHEDRINE HYDROCHLORIDE	240MG	tablet, extended release · oral	AUROBINDO PHARMA LTD	Over-the-counter	29 Dec 2025
NOVAFED	120MG	capsule, extended release · oral	SANOFI AVENTIS US	Discontinued	29 Aug 1975
AFRINOL	120MG	tablet, extended release · oral	SCHERING PLOUGH	Discontinued	30 Oct 1980
SUDAFED 12 HOUR	120MG	tablet, extended release · oral	MCNEIL CONS	Discontinued	31 Oct 1991
SUDAFED 24 HOUR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, extended release · oral	KENVUE BRANDS	Discontinued	15 Dec 1992
SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule, extended release · oral	GLAXOSMITHKLINE	Discontinued

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PSEUDOEPHEDRINE 30 MG TABLET	$0.07757	per EA	23 Sep 2026
US NADAC	PSEUDOEPHEDRINE 60 MG TABLET	$0.07747	per EA	23 Sep 2026
US NADAC	PSEUDOEPHEDRINE ER 120 MG TAB	$0.28111	per EA	23 Sep 2026
NHS Drug Tariff	Pseudoephedrine 30mg/5ml oral solution	£2.87	100 ml	1 Oct 2026
NHS Drug Tariff	Pseudoephedrine hydrochloride 60mg tablets	£3.94	12 tablet	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 2 Jul 2026 ZYRTEC-D 12 HOUR — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 22 Dec 2025 HYCOFENIX — 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
MHRA 20 Feb 2024 Pseudoephedrine: very rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.
US FDA 11 Jul 2023 ALEVE-D SINUS & COLD — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 1 Dec 2021 SINE-AID IB — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 23 Nov 2021 ADVIL ALLERGY SINUS — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 19 Nov 2021 ADVIL COLD AND SINUS — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 19 Nov 2021 ADVIL COLD AND SINUS — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 15 Mar 2019 CLARINEX D 24 HOUR — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Mar 2019 CLARINEX-D 12 HOUR — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Jun 2018 REZIRA — 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 28 Jun 2018 ZUTRIPRO — 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 11 Apr 2018 SEMPREX-D — safety-related labeling change
Labeling sections changed: Adverse Reactions
US FDA 3 Apr 2017 CHILDREN'S MOTRIN COLD — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 24 Mar 2017 CHILDREN'S ADVIL ALLERGY SINUS — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for pseudoephedrine →

Combinations containing Pseudoephedrine

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.