Is Sodium chloride registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 86 valid registrations of Sodium chloride, including 0.45% w/v Sodium Chloride Injection 500 ml (0.45 %, Solution for infusion, SAR 6.20); 0.9% W/V SODIUM CHLORIDE B.P (0.9 %, Solution for injection, SAR 0.75); 0.9% W/V SODIUM CHLORIDE INJECTION B.P (0.9 %, Solution for injection, SAR 1.70); 0.9% w/v SODIUM CHLORIDE for irrigation (0.9 %, Irrigation solution, SAR 23.00); 0.9% w/v Sodium Chloride (0.9 % (V/W), Solution for infusion, SAR 26.65).

Is Sodium chloride approved by the US FDA?

Drugs@FDA lists 68 application product lines for Sodium chloride, including SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Prescription); SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Prescription); SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Prescription); SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Prescription); SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Prescription).

Is Sodium chloride on the WHO Model List of Essential Medicines?

Yes — 26.2. Solutions correcting water, electrolyte and acid-base disturbances > Parenteral (core list): Other specified disorders of fluid, electrolyte or acid-base balance.

Are there safety signals or safety updates for Sodium chloride?

US FDA: 18 entries (latest 2025-11-05).

Active substance

Sodium chloride

SFDA 162
US FDA 68
Health Canada 20
US price lines 5
NHS prices 11
WHO EML 1
Safety 18

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
0.45% w/v Sodium Chloride Injection 500 ml	0.45 %	Solution for infusion · Intravenous use	1 Bottle	SAR 6.20	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
0.9% W/V SODIUM CHLORIDE B.P	0.9 %	Solution for injection · Parenteral use	1 Bottle	SAR 0.75	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
0.9% W/V SODIUM CHLORIDE INJECTION B.P	0.9 %	Solution for injection · Parenteral use	1 Bottle	SAR 1.70	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
0.9% W/V SODIUM CHLORIDE INJECTION B.P	0.9 %	Solution for injection · Parenteral use	1 Bottle	SAR 1.00	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
0.9% w/v SODIUM CHLORIDE for irrigation	0.9 %	Irrigation solution · Topical	1 Bag	SAR 23.00	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
0.9% w/v Sodium Chloride	0.9 % (V/W)	Solution for infusion · Intravenous use	1 Bag	SAR 26.65	Generic · Prescription	Pharmaceutical Solutions Industry Ltd	Valid
7.5% Sodium Chloride Intravenous Infusion	7.5 %	Solution for infusion · Intravenous use	1 Bag	SAR 34.50	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
APISAL 0.9% EYE-NOSE DROPS	0.9 %	Ear/eye/nose drops, solution · Ophthalmic use	1 Dropper Container	SAR 5.70	Generic · OTC	Amman Pharmaceutical Industries (API)	Valid
Apisal	5 %	Eye ointment · Ophthalmic use	1 Tube	SAR 29.75	Generic · OTC	Amman Pharmaceutical Industries (API)	Valid
NORMAL SALINE (0.9% W/V SODIUM CHLORIDE) INJECTION	0.9 %	Solution · Intravenous use	20 Bottle	SAR 137.00	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
NORMAL SALINE (0.9% W/V SODIUM CHLORIDE) INJECTION	0.9 %	Solution for injection · Intravenous use	40 Bottle	SAR 238.00	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
NORMAL SALINE (0.9% W/V SODIUM CHLORIDE) INJECTION	0.9 %	Solution for injection · Intravenous use	100 Ampoule	SAR 75.00	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
NORMAL SALINE (0.9% W/V SODIUM CHLORIDE) INJECTION	0.9 %	Solution for injection · Intravenous use	100 Ampoule	SAR 100.00	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
NORMAL SALINE (0.9% W/V SODIUM CHLORIDE) INJECTION	0.9 %	Solution for injection · Intravenous use	50 Bottle	SAR 160.00	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
NORMAL SALINE (0.9% W/V SODIUM CHLORIDE) INJECTION	0.9 %	Solution for injection · Intravenous use	50 Bottle	SAR 170.00	Generic · Prescription	AL RAZI PHARMA INDUSTRIES	Valid
NORMAL SALINE I.V. INFUSION	0.9 %	Solution · Parenteral use	1 Bottle	SAR 5.95	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
NORMAL SALINE I.V. INFUSION	0.9 %	Solution · Parenteral use	1 Bottle	SAR 6.30	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
NORMAL SALINE I.V. INFUSION	0.9 %	Solution · Parenteral use	1 Bottle	SAR 3.40	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
NORMAL SALINE I.V. INFUSION	0.9 %	Solution · Parenteral use	1 Bottle	SAR 9.65	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
NORMAL SALINE I.V. INFUSION	0.9 %	Solution · Parenteral use	1 Bottle	SAR 3.20	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
SOD. CHLORIDE 0.225% I.V SOLUTION	0.225 %	Intravenous infusion · Parenteral use	1 Bottle	SAR 6.30	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
SOD. CHLORIDE 0.225% I.V SOLUTION	0.225 %	Intravenous infusion · Parenteral use	1 Bottle	SAR 5.85	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
SOD. CHLORIDE 0.225% I.V SOLUTION	0.225 %	Intravenous infusion · Parenteral use	1 Bag	SAR 5.95	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
SOD. CHLORIDE 0.225% I.V SOLUTION	0.225 %	Intravenous infusion · Parenteral use	1 Bag	SAR 6.60	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
SOD. CHLORIDE 0.225% I.V SOLUTION	0.225 %	Intravenous infusion · Parenteral use	1 Bag	SAR 5.35	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid

137 more — full table

Indications — CHI Daman Drug Formulary

ACUTE KIDNEY INJURY (AKI); ACUTE PANCREATITIS; ANAPHYLACTIC SHOCK; ANESTHESIA-SUPPORTIVE AGENTS/ FLUID RESUSCITATION (UNCONTROLLED BLEEDING); BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - VIBRIO CHOLERAE; CENTRAL DIABETES INSIPIDUS; DIABETIC KETOACIDOSIS; FLUIDS AND VOLUME EXPANDERS-MAINTENANCE FLUIDS; INFECTIOUS DIARRHEA-SUPPORTIVE TREATMENT; Septic Shock; VIRAL GASTROENTERITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	solution · irrigation	B BRAUN	Prescription	12 Aug 1970
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML; 450MG/50ML (9MG/ML); 225MG/25ML (9MG/ML)	solution · injection	BAXTER HLTHCARE	Prescription	9 Dec 1970
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	24 Feb 1972
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	solution · irrigation	OTSUKA ICU MEDCL	Prescription	8 Apr 1974
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	solution · irrigation	BAXTER HLTHCARE	Prescription	31 Dec 1974
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	injectable · injection	B BRAUN	Prescription	8 Feb 1978
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	2 Feb 1979
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	4 Apr 1979
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	solution · irrigation	OTSUKA ICU MEDCL	Prescription	22 Feb 1980
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	solution · irrigation	BAXTER HLTHCARE	Prescription	30 May 1980
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML); 180MG/20ML (9MG/ML); 270MG/30ML (9MG/ML)	solution · injection	HOSPIRA	Prescription	29 Oct 1982
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML); 180MG/20ML (9MG/ML); 450MG/50ML (9MG/ML)	solution · injection	HOSPIRA	Prescription	29 Oct 1982
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	1 Nov 1983
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	1 Nov 1983
SODIUM CHLORIDE 14.6%	100MEQ/40ML (2.5MEQ/ML)	solution · intravenous	HOSPIRA	Prescription	20 Jul 1984
SODIUM CHLORIDE 23.4%	400MEQ/100ML (4MEQ/ML)	solution · intravenous	HOSPIRA	Prescription	20 Jul 1984
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML); 180MG/20ML (9MG/ML); 270MG/30ML (9MG/ML); 18MG/2ML (9MG/ML)	solution · injection	FRESENIUS KABI USA	Prescription	10 Jan 1985
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML); 90MG/10ML (9MG/ML)	solution · injection	FRESENIUS KABI USA	Prescription	7 Feb 1985
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	900MG/100ML	solution for slush · irrigation	BAXTER HLTHCARE	Prescription	17 May 1985
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML; 450MG/50ML (9MG/ML)	solution · injection	HOSPIRA	Prescription	15 Jul 1985
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	injectable · injection	HOSPIRA	Prescription	17 Sep 1985
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	injectable · injection	B BRAUN	Prescription	9 Mar 1988
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	injectable · injection	B BRAUN	Prescription	9 Mar 1988
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	3GM/100ML	injectable · injection	B BRAUN	Prescription	9 Mar 1988
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	5GM/100ML	injectable · injection	B BRAUN	Prescription	9 Mar 1988

43 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
0.45% SODIUM CHLORIDE INJECTION USP	01927949	4.5 MG / ML	SOLUTION · INTRAVENOUS	B. BRAUN MEDICAL INC
0.9% SODIUM CHLORIDE INJECTION	02395150	900 MG / 100 ML	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
0.9% SODIUM CHLORIDE INJECTION USP	01924303	0.9 %	SOLUTION · INTRAVENOUS	B. BRAUN MEDICAL INC
0.9% SODIUM CHLORIDE INJECTION USP	02150204	9 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUS	OMEGA LABORATORIES LIMITED
0.9% SODIUM CHLORIDE INJECTION USP	02304341	9 MG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULAR	HIKMA CANADA LIMITED
0.9% SODIUM CHLORIDE INJECTION, USP	00060208	900 MG / 100 ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
0.9% SODIUM CHLORIDE IRRIGATION, USP	00786160	900 MG / 100 ML	SOLUTION · IRRIGATION	BAXTER CORPORATION
12% SODIUM CHLORDIE PROCESSING SOLUTION	00783625	12 G / 100 ML	SOLUTION · 0-UNASSIGNED	BAXTER CORPORATION
20% SODIUM CHLORIDE INJECTION, BP	02514184	20 % / W/V	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
5% SODIUM CHLORIDE INJECTION USP	01928007	5 G / 100 ML	SOLUTION · INTRAVENOUS	B. BRAUN MEDICAL INC
BACTERIOSTATIC SODIUM CHLORIDE INJECTION USP	00037818	9 MG / ML	SOLUTION · INTRAMUSCULAR; SUBCUTANEOUS; INTRAVENOUS	PFIZER CANADA ULC
SODIUM CHLORIDE 0.45% INJ	00060186	450 MG / 100 ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
SODIUM CHLORIDE 3% INJ	00060232	3 G / 100 ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
SODIUM CHLORIDE BACTERIOSTATIC INJ	00402249	9 MG / ML	LIQUID · INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS	OMEGA LABORATORIES LIMITED
SODIUM CHLORIDE INJECTION USP	00037796	9 MG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRAPERITONEAL; INTRAMUSCULAR	PFIZER CANADA ULC
SODIUM CHLORIDE INJECTION USP	00037842	9 MG / ML	SOLUTION · INTRAVENOUS	ICU MEDICAL CANADA INC
SODIUM CHLORIDE INJECTION USP, 0.9% W/V	02560100	9 MG / ML	SOLUTION · INTRAVENOUS	STERINOVA INC.
SODIUM CHLORIDE INJECTION, USP	02139510	234 MG / ML	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
SODIUM CHLORIDE IRRIGATION USP	00037826	9 MG / ML	SOLUTION · IRRIGATION; INTRAPERITONEAL	ICU MEDICAL CANADA INC
SODIUM CHLORIDE IRRIGATION USP	00037834	9 MG / ML	SOLUTION · TOPICAL; INTRAPERITONEAL; IRRIGATION	ICU MEDICAL CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SODIUM CHLORIDE 0.9% SOLUTION	$0.00208	per ML	23 Sep 2026
US NADAC	SODIUM CHLORIDE 0.9% VIAL	$0.08875	per ML	23 Sep 2026
US NADAC	SODIUM CHLORIDE 1 GM TABLET	$0.06817	per EA	23 Sep 2026
US NADAC	SODIUM CHLORIDE 5% EYE DROP	$0.32865	per ML	23 Sep 2026
US NADAC	SODIUM CHLORIDE 5% EYE OINT	$2.99016	per GM	23 Sep 2026
NHS Drug Tariff	Sodium chloride 0.9% eye drops 0.5ml unit dose preservative free	£7.92	20 unit dose	1 Oct 2026
NHS Drug Tariff	Sodium chloride 0.9% nebuliser liquid 2.5ml unit dose ampoules	£15.50	20 unit dose	1 Oct 2026
NHS Drug Tariff	Sodium chloride 0.9% solution for injection 10ml ampoules	£5.83	10 ampoule	1 Oct 2026
NHS Drug Tariff	Sodium chloride 0.9% solution for injection 20ml ampoules	£24.60	20 ampoule	1 Oct 2026
NHS Drug Tariff	Sodium chloride 0.9% solution for injection 2ml ampoules	£3.50	10 ampoule	1 Oct 2026
NHS Drug Tariff	Sodium chloride 0.9% solution for injection 50ml vials	£93.50	25 vial	1 Oct 2026
NHS Drug Tariff	Sodium chloride 0.9% solution for injection 5ml ampoules	£4.49	10 ampoule	1 Oct 2026
NHS Drug Tariff	Sodium chloride 1.46g/5ml (5mmol/ml) oral solution	£22.46	100 ml	1 Oct 2026
NHS Drug Tariff	Sodium chloride 292.5mg/5ml (1mmol/ml) oral solution	£33.16	100 ml	1 Oct 2026
NHS Drug Tariff	Sodium chloride 30% solution for injection 10ml ampoules	£90.46	10 ampoule	1 Oct 2026
NHS Drug Tariff	Sodium chloride 600mg modified-release tablets	£21.95	100 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.

WHO WHO Model List of Essential Medicines (2025)

26.2. Solutions correcting water, electrolyte and acid-base disturbances > Parenteral · core
Other specified disorders of fluid, electrolyte or acid-base balance
Parenteral > General injections > IV: 0.9% isotonic (equivalent to Na+ 154 mmol/L and Cl- 154 mmol/L)

Safety signals and safety-related labeling changes

US FDA 5 Nov 2025 LACTATED RINGER'S IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
US FDA 5 Nov 2025 LACTATED RINGER'S IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions
US FDA 5 Nov 2025 RINGER'S IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions
US FDA 8 Sep 2023 PLENVU — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 6 Apr 2022 MOVIPREP — 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 14 May 2021 GOLYTELY — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 May 2021 COLYTE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 May 2021 COLYTE WITH FLAVOR PACKS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 May 2021 COLYTE-FLAVORED — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 May 2021 NULYTELY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 May 2021 NULYTELY-FLAVORED — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Aug 2019 PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 5 Aug 2019 PLASMA-LYTE A IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 1 May 2019 NORMOCARB HF 25 — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 1 May 2019 NORMOCARB HF 35 — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for sodium chloride →

Combinations containing Sodium chloride

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.