Is Lactulose registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Lactulose, including DUPHALAC ORAL SOLUTION (667 g/l, Oral solution, SAR 24.40); EZILAX 10G-15ML SYRUP (0.67 g/ml, Syrup, SAR 21.95); KULAX 65MG-100ML SYRUP (0.65 mg/ml, Syrup, SAR 15.25); LACTULOSE syrup (0.65 g/ml, Syrup, SAR 17.00); LAXILOSE SYRUP (67 %, Syrup, SAR 18.45).

Is Lactulose approved by the US FDA?

Drugs@FDA lists 38 application product lines for Lactulose, including LACTULOSE (Prescription); GENERLAC (Prescription); LACTULOSE (Prescription); LACTULOSE (Prescription); LACTULOSE (Prescription).

Is Lactulose on the WHO Model List of Essential Medicines?

Yes — 2.3. Medicines for other common symptoms in palliative care (core list): Palliative care.

Active substance

Lactulose

SFDA 15
US FDA 38
Health Canada 5
US price lines 12
NHS prices 2
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DUPHALAC ORAL SOLUTION	667 g/l	Oral solution · Oral use	1 Bottle	SAR 24.40	NCE · OTC	ABBOTT BIOLOGICALS	Valid
EZILAX 10G-15ML SYRUP	0.67 g/ml	Syrup · Oral use	1 Bottle	SAR 21.95	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Valid
KULAX 65MG-100ML SYRUP	0.65 mg/ml	Syrup · Oral use	1 Bottle	SAR 15.25	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
KULAX 65MG-100ML SYRUP	0.65 mg/ml	Syrup · Oral use	1 Bottle	SAR 10.15	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
LACTULOSE syrup	0.65 g/ml	Syrup · Oral use	1 Bottle	SAR 17.00	Generic · OTC	EIPICO	Valid
LAXILOSE SYRUP	67 %	Syrup · Oral use	1 Bottle	SAR 18.45	Generic · OTC	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
LAXOLAC SYRUP	0.65 g/ml	Syrup · Oral use	1 Bottle	SAR 7.00	Generic · OTC	MEDICAL UNION PHARMACEUTICALS CO	Valid
LAXOLAC SYRUP	0.65 g/ml	Syrup · Oral use	1 Bottle	SAR 15.25	Generic · OTC	MEDICAL UNION PHARMACEUTICALS CO	Valid
SOFLAX SOLUTION	0.67 g/ml	Solution · Oral use	1 Bottle	SAR 9.95	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
DEFOLAX 65GM-100ML SYRUP	0.65 g/ml	Syrup · Oral use	1 Bottle	SAR 11.20	Generic · OTC	DEEF PHARMACEUTICAL INDUSTRIES	Withdrawn by MAH · Not Marketed
EZILAX 10GM POWDER SACHET	10 g	Powder for oral solution · Oral use	20 Sachet	SAR 16.80	NCE · OTC	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
RAMLAC 67GM-100ML SYRUP	0.67 g/ml	Syrup · Oral use	1 Bottle	SAR 13.75	Generic · OTC	Ram Pharmaceutical Industries	Withdrawn by MAH · Not Marketed
RIALAC LIQUID	0.67 g/ml	Oral solution · Oral use	1 Bottle	SAR 11.10	Generic · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
RIALAC LIQUID	0.67 g/ml	Oral solution · Oral use	1 Bottle	SAR 15.55	Generic · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
SEDALAC SYRUP 3.35G-5ML	0.65 g/ml	Oral solution · Oral use	1 Bottle	SAR 6.30	Generic · OTC	SEDICO	Withdrawn by regulatory authority · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE LIVER FAILURE - HEPATIC ENCEPHALOPATHY/HYPERAMMONEMIA; ANAL FISSURE; CONSTIPATION; HEMORRHOIDS; IRRITABLE BOWEL SYNDROME; LIVER CIRRHOSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
LACTULOSE	10GM/15ML	solution · oral	PHARM ASSOC	Prescription	30 Jul 1996
GENERLAC	10GM/15ML	solution · oral, rectal	CHARTWELL RX	Prescription	31 Oct 1996
LACTULOSE	10GM/15ML	solution · oral	AUROBINDO PHARMA LTD	Prescription	14 Nov 1996
LACTULOSE	10GM/PACKET; 20GM/PACKET	for solution · oral	APOTEX	Prescription	10 Dec 1997
LACTULOSE	10GM/15ML	solution · oral	LANNETT CO INC	Prescription	26 Jul 2001
LACTULOSE	10GM/15ML	solution · oral	PHARMOBEDIENT	Prescription	21 Feb 2002
LACTULOSE	10GM/15ML	solution · oral, rectal	BAJAJ	Prescription	28 Jul 2003
LACTULOSE	10GM/15ML	solution · oral, rectal	FRESENIUS KABI	Prescription	25 Jan 2012
LACTULOSE	10GM/15ML	solution · oral	FRESENIUS KABI	Prescription	25 Jan 2012
LACTULOSE	10GM/15ML	solution · oral, rectal	APOZEAL PHARMS	Prescription	27 Mar 2015
LACTULOSE	10GM/15ML	solution · oral	APOZEAL PHARMS	Prescription	11 Jun 2018
LACTULOSE	10GM/15ML	solution · oral	CHARTWELL RX	Prescription	23 Nov 2018
LACTULOSE	10GM/15ML	solution · oral	TARO	Prescription	13 Dec 2024
LACTULOSE	10GM/PACKET; 20GM/PACKET	for solution · oral	PAI HOLDINGS	Prescription	14 Mar 2025
CEPHULAC	10GM/15ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · oral, rectal	SANOFI AVENTIS US	Discontinued	25 Mar 1976
CHRONULAC	10GM/15ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · oral	SANOFI AVENTIS US	Discontinued	20 Jun 1979
CONSTILAC	10GM/15ML	solution · oral	ALRA	Discontinued	26 Jul 1988
CHOLAC	10GM/15ML	solution · oral, rectal	ALRA	Discontinued	26 Jul 1988
CONSTULOSE	10GM/15ML	solution · oral	ACTAVIS MID ATLANTIC	Discontinued	15 Aug 1988
ENULOSE	10GM/15ML	solution · oral, rectal	ACTAVIS MID ATLANTIC	Discontinued	15 Aug 1988
LACTULOSE	10GM/15ML	solution · oral, rectal	ROXANE	Discontinued	29 May 1992
LACTULOSE	10GM/15ML	solution · oral	HIKMA PHARMS	Discontinued	29 May 1992
LACTULOSE	10GM/15ML	solution · oral	VISTAPHARM LLC	Discontinued	30 Sep 1992
EVALOSE	10GM/15ML	solution · oral	TEVA PHARMS	Discontinued	28 May 1993
HEPTALAC	10GM/15ML	solution · oral, rectal	TEVA PHARMS	Discontinued	28 May 1993

13 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JAMP-LACTULOSE	02295881	667 MG / ML	SOLUTION · ORAL	JAMP PHARMA CORPORATION
LACTULOSE	02412268	667 MG / ML	SOLUTION · ORAL	SANIS HEALTH INC
PMS-LACTULOSE-PHARMA	02469391	667 MG / ML	SOLUTION · ORAL	PHARMASCIENCE INC
RATIO-LACTULOSE	00854409	667 MG / ML	SOLUTION · ORAL	TEVA CANADA LIMITED
TEVA-LACTULOSE	02331551	667 MG / ML	SOLUTION · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CONSTULOSE 10 GM/15 ML SOLN	$0.01947	per ML	23 Sep 2026
US NADAC	CONSTULOSE 10 GM/15 ML SOLN	$0.01939	per ML	23 Sep 2026
US NADAC	ENULOSE 10 GM/15 ML SOLUTION	$0.01304	per ML	23 Sep 2026
US NADAC	GENERLAC 10 GM/15 ML SOLUTION	$0.01304	per ML	23 Sep 2026
US NADAC	LACTULOSE 10 GM PACKET	$8.22014	per EA	23 Sep 2026
US NADAC	LACTULOSE 10 GM/15 ML SOLUTION	$0.01947	per ML	23 Sep 2026
US NADAC	LACTULOSE 10 GM/15 ML SOLUTION	$0.02237	per ML	23 Sep 2026
US NADAC	LACTULOSE 10 GM/15 ML SOLUTION	$0.01939	per ML	23 Sep 2026
US NADAC	LACTULOSE 10 GM/15 ML SOLUTION	$0.01304	per ML	23 Sep 2026
US NADAC	LACTULOSE 10 GM/15 ML SOLUTION	$0.0125	per ML	23 Sep 2026
US NADAC	LACTULOSE 20 GM PACKET	$8.51402	per EA	23 Sep 2026
US NADAC	LACTULOSE 20 GM/30 ML SOLUTION CUP	$0.0512	per ML	18 Feb 2026
NHS Drug Tariff	Lactulose 10g/15ml oral solution 15ml sachets sugar free	£3.52	10 sachet	1 Oct 2026
NHS Drug Tariff	Lactulose 3.1-3.7g/5ml oral solution	£3.63	500 ml	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.

WHO WHO Model List of Essential Medicines (2025)

2.3. Medicines for other common symptoms in palliative care · core
Palliative care
Oral > Liquid: 3.3 to 3.4 g per 5 mL oral liquid (EMLc)

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.