Is Chlorphenamine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Chlorphenamine, including ALLERFIN AMP 10MG-ML (10 mg/ml, Solution, SAR 6.05); ALLERFIN TABLETS 4MG (4 mg, Tablet, SAR 2.55); CHLOROHISTOL 10MG-ML Injection* (10 mg/ml, Solution for injection, SAR 6.35); CHLOROHISTOL SYRUP 2 MG - 5 ML (0.4 mg/ml, Syrup, SAR 5.65); CHLOROHISTOL TAB 4 MG. (4 mg, Tablet, SAR 6.65).

Is Chlorphenamine approved by the US FDA?

Drugs@FDA lists 41 application product lines for Chlorphenamine, including CHLORPHENIRAMINE MALEATE (Over-the-counter); CHLOR-TRIMETON (Discontinued); CHLOR-TRIMETON (Discontinued); CHLOR-TRIMETON (Discontinued); CHLORPHENIRAMINE MALEATE (Discontinued).

Are there safety signals or safety updates for Chlorphenamine?

US FDA: 7 entries (latest 2026-07-10).

Active substance

Chlorphenamine

SFDA 18
US FDA 41
Health Canada 1
NHS prices 4
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALLERFIN AMP 10MG-ML	10 mg/ml	Solution · Intravenous use	5 Ampoule	SAR 6.05	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ALLERFIN TABLETS 4MG	4 mg	Tablet · Oral use	30 Blister	SAR 2.55	Generic · OTC	APM	Valid
CHLOROHISTOL 10MG-ML Injection*	10 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 6.35	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
CHLOROHISTOL SYRUP 2 MG - 5 ML	0.4 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.65	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
CHLOROHISTOL TAB 4 MG.	4 mg	Tablet · Oral use	20 Blister	SAR 6.65	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
HISTOP 2MG-5ML SYRUP	0.4 mg/ml	Syrup · Oral use	1 Bottle	SAR 6.90	Generic · OTC	SPIMACO ADDWAEIH	Valid
HISTOP TAB 4MG	4 mg	Tablet · Oral use	20 Blister	SAR 6.90	Generic · OTC	SPIMACO ADDWAEIH	Valid
Zistan	4 mg	Tablet · Oral use	1000 Blister	SAR 56.60	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Zistan 4 MG TABLETS	4 mg	Tablet · Oral use	20 Blister	SAR 6.10	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Zistan SYRUP	0.4 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.40	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
ALLERFIN SYRUP 2.5MG-5ML	0.5 mg/ml	Syrup · Oral use	1 Bottle	SAR 2.90	NCE · OTC	APM	Withdrawn by MAH · Not Marketed
ANALLERGE 4 MG TAB	4 mg	Tablet · Oral use	20 Blister	SAR 4.15	Generic · OTC	KAHIRA EYGEPT	Withdrawn by regulatory authority · Not Marketed
CHLORPHENIRAMINE	0.4 mg/ml	Syrup · Oral use	1 Bottle	SAR 6.25	Generic · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
GRIPINE 2MG-5ML SYRUP	0.4 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.65	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
PHENIRAM 2MG\5ML SYRUP	0.4 mg/ml	Syrup · Oral use	1 Bottle	SAR 4.75	Generic · OTC	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	Withdrawn by MAH · Not Marketed
PHENIRAM 4MG TABLET	4 mg	Tablet · Oral use	20 Blister	SAR 5.35	Generic · OTC	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	Withdrawn by MAH · Not Marketed
PIRAFENE SYRUP 2MG-5ML	0.5 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.15	Generic · OTC	MEMPHIS CHEMICALS	Withdrawn by regulatory authority · Not Marketed
PIRAFENE TAB 4MG	4 mg	Tablet · Oral use	20 Blister	SAR 3.35	Generic · OTC	MEMPHIS CHEMICALS	Withdrawn by regulatory authority · Not Marketed

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; ADULT ACUTE MYELOID LEUKAEMIA (AML); BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; BREAST CANCER EARLY HER-2 -VE -ADVERSE REACTION MANAGEMENT; BREAST CANCER HER-2 +VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET.HER-2 +VE-ADVERSE REACTION MANAGEMENT; BREAST CANCER MET.HER-2 -VE-ADVERSE REACTION MANAGEMENT; BURKITT`S LYMPHOMA; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); COLORECTAL CANCER-HYPERSENSITIVITY REACTIONS, CUTANEOUS REACTIONS, FLUID RETENTION; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); ESOPHAGEAL CANCER-HYPERSENSITIVITY REACTIONS, CUTANEOUS REACTIONS, FLUID RETENTION; FOLLICULAR LYMPHOMA; GASTRIC CANCER-HYPERSENSITIVITY REACTIONS, CUTANEOUS REACTIONS, FLUID RETENTION; HODGKIN'S LYMPHOMA; HUMAN IMMUNODEFICIENCY VIRUS; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL)-ADVERSE REACTIONS MANAGEMENT; PEDIATRIC B-CELL LYMPHOMA; PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS - PRURITUS; PROSTATE CANCER; RHEUMATOID ARITHRITIS-SUPPORTIVE CARE AND ADRS MANAGEMENT; T-CELL LYMPHOMA; THROMBOTIC THROMBOCYTOPENIC PURPURA; TUBERCULOSIS-SUPPORTIVE CARE

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

Product	Strength	Form · route	Applicant	Status	First approved
CHLORPHENIRAMINE MALEATE	12MG	tablet, extended release · oral	AVANTHI INC	Over-the-counter	13 May 2009
CHLOR-TRIMETON	4MG	tablet · oral	SCHERING	Discontinued	13 Jul 1949
CHLOR-TRIMETON	2MG/5ML	syrup · oral	SCHERING	Discontinued	13 Jul 1949
CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, extended release · oral	BAYER HEALTHCARE LLC	Discontinued	15 Aug 1950
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	IVAX SUB TEVA PHARMS	Discontinued	9 May 1972
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	SUN PHARM INDUSTRIES	Discontinued	24 Aug 1972
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	AUROLIFE PHARMA LLC	Discontinued	20 Dec 1972
ANTAGONATE	4MG	tablet · oral	BAYER PHARMS	Discontinued	20 Mar 1973
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	WEST WARD	Discontinued	18 Oct 1973
CHLORPHENIRAMINE MALEATE	10MG/ML	injectable · injection	BEL MAR	Discontinued	29 Nov 1973
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	PHARMERAL	Discontinued	21 Jun 1974
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	WATSON LABS	Discontinued	18 Oct 1974
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	PHARMAVITE	Discontinued	11 Feb 1977
CHLORPHENIRAMINE MALEATE	10MG/ML	injectable · injection	WATSON LABS	Discontinued	5 Jul 1977
PYRIDAMAL 100	100MG/ML	injectable · injection	BEL MAR	Discontinued	23 Jan 1979
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	NEWTRON PHARMS	Discontinued	9 Feb 1979
CHLORPHENIRAMINE MALEATE	10MG/ML	injectable · injection	WATSON LABS	Discontinued	9 Oct 1979
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	KV PHARM	Discontinued	22 Jul 1981
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	PIONEER PHARMS	Discontinued	13 Jul 1984
CHLORPHENIRAMINE MALEATE	12MG	capsule, extended release · oral	AUROLIFE PHARMA LLC	Discontinued	12 Aug 1988
EFIDAC 24 CHLORPHENIRAMINE MALEATE	16MG	tablet, extended release · oral	ALZA	Discontinued	18 Nov 1994
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	ROXANE	Discontinued
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	PVT FORM	Discontinued
CHLORPHENIRAMINE MALEATE	4MG	tablet · oral	WATSON LABS	Discontinued
CHLORPHENIRAMINE MALEATE	10MG/ML	injectable · injection	ELKINS SINN	Discontinued

16 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TEVA-PHENIRAM	00021288	4 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Chlorphenamine 10mg/1ml solution for injection ampoules	£25.49	5 ampoule	1 Oct 2026
NHS Drug Tariff	Chlorphenamine 2mg/5ml oral solution	£4.05	150 ml	1 Oct 2026
NHS Drug Tariff	Chlorphenamine 2mg/5ml oral solution sugar free	£31.58	150 ml	1 Oct 2026
NHS Drug Tariff	Chlorphenamine 4mg tablets	£0.89	28 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 10 Jul 2026 TUXARIN ER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Nov 2021 ADVIL ALLERGY AND CONGESTION RELIEF — 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 28 Jun 2018 CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE — 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 VITUZ — 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 24 Mar 2017 CHILDREN'S ADVIL ALLERGY SINUS — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for chlorphenamine →

Combinations containing Chlorphenamine

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.