Overview
Sodium chloride, also known as salt, common salt, table salt or halite, is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. Sodium chloride is the primary salt in seawater and in the extracellular fluid of many multicellular organisms. It is listed on the World Health Organization Model List of Essential Medicines.
Indication
This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. Also, designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.
Associated Conditions
- Allergic Rhinitis (AR)
- Corneal Edema
- Dehydration
- Dehydration Hypertonic
- Fluid Loss
- Hemodilution
- Hypokalemia
- Hyponatremia
- Hypotonic Dehydration
- Hypovolaemia
- Increase in Intracranial Pressure (ICP)
- Increased Intra Ocular Pressure (IOP)
- Inflammation of the Nasal Mucosa
- Isotonic Dehydration
- Metabolic Acidosis
- Nasal Congestion
- Nasal irritation
- Oliguria caused by Acute Renal Failure (ARF)
- Potassium deficiency
- Sinusitis
- Skin Irritation
- Sodium Depletion
- Dryness of the nose
- Hypochloremic state
- Mild Metabolic acidosis
- Mild, moderate Metabolic Acidosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/14 | Not Applicable | Not yet recruiting | |||
2025/07/08 | Not Applicable | Not yet recruiting | |||
2025/03/12 | Not Applicable | Not yet recruiting | |||
2024/10/02 | Phase 4 | ENROLLING_BY_INVITATION | |||
2024/07/10 | Phase 4 | Completed | Haseki Training and Research Hospital | ||
2024/03/12 | Phase 2 | Recruiting | Gabriella Milos | ||
2024/03/08 | Phase 1 | Active, not recruiting | Martin Blomberg Jensen | ||
2023/11/02 | Phase 4 | Completed | Linkoeping University | ||
2022/11/21 | Phase 2 | Active, not recruiting | |||
2022/11/08 | Phase 1 | Withdrawn | Wuhan Rhegen Biotechnology Co., Ltd. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 0338-0190 | IRRIGATION | 800 mg in 100 mL | 2/21/2014 | |
| Baxter Healthcare Corporation | 0338-0085 | INTRAVENOUS | 450 mg in 100 mL | 8/22/2019 | |
| Fresenius Kabi USA, LLC | 65219-153 | INTRAVENOUS | 2.25 g in 1000 mL | 3/2/2017 | |
| Bestmade Natural Products | 82969-3027 | ORAL | 6 [hp_X] in 6 [hp_X] | 1/22/2025 | |
| Baxter Healthcare Company | 0338-0210 | INTRAVENOUS | 205 mg in 100 mL | 9/21/2020 | |
| Baxter Healthcare Corporation | 0338-0210 | INTRAVENOUS | 205 mg in 100 mL | 9/21/2020 | |
| ICU Medical Inc. | 0990-7925 | INTRAVENOUS | 0.3 g in 100 mL | 10/18/2021 | |
| IT3 Medical LLC | 70529-021 | INTRAVENOUS | 9 mg in 1 mL | 6/13/2018 | |
| Baxter Healthcare Corporation | 0338-0117 | INTRAVENOUS | 600 mg in 100 mL | 10/9/2019 | |
| Laboratorios Alfa SRL | 72483-303 | INTRAVENOUS | 9 mg in 1 mL | 6/6/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PRISMASOL B0 SOLUTION FOR HAEMOFILTRATION AND HAEMODIALYSIS | N/A | N/A | N/A | 10/15/2013 | |
| EXTRANEAL SOLN 7.5% | N/A | N/A | N/A | 8/18/2000 | |
| SODIUM CHLORIDE 0.45%W/V AND GLUCOSE 2.5%W/V SOLUTION FOR INTRAVENOUS INFUSION | N/A | N/A | N/A | 3/17/2015 | |
| RINGER'S INJ | N/A | otsuka pharmaceutical (h.k.) limited | N/A | N/A | 5/15/2008 |
| LACTATED RINGER'S INJ | N/A | N/A | N/A | 5/17/1979 | |
| ISOCOLAN POWDER FOR ORAL SOLUTION | N/A | N/A | N/A | 8/19/2024 | |
| BALANCE 4.25% GLU. 1.25MMOL/L CAL. P.D. SOLUTION (JAPAN) | N/A | N/A | N/A | 7/12/2005 | |
| NUTRIFLEX OMEGA SPECIAL EMULSION FOR INFUSION | N/A | N/A | N/A | 1/11/2012 | |
| PLASMA-LYTE 148 AND GLUCOSE 5% W/V SOLUTION FOR INFUSION | N/A | N/A | N/A | 8/23/2024 | |
| WIDA RL RINGER LACTATE INTRAVENOUS INFUSION | N/A | otsuka pharmaceutical (h.k.) limited | N/A | N/A | 10/30/2009 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Trainade Lemon Lime | 380939 | Medicine | A | 12/16/2021 | |
| Pfizer (Australia) SODIUM CHLORIDE 0.9% (450mg/50mL) intravenous infusion | 10804 | Medicine | A | 7/9/1991 | |
| ENDURA LOW CARB HYDRATION COCONUT | 330951 | Medicine | A | 3/10/2020 | |
| SYNTHAMIN 17 Amino acid 10% with Electrolytes and Glucose 25% 1000mL injection AHB6350 | 19609 | Medicine | A | 9/30/1991 | |
| HYDRAlyte Ready to Use Orange Flavoured Electrolyte Solution | 90732 | Medicine | A | 8/26/2002 | |
| SLEEP SAFE BALANCE 1.5% glucose 1.75 mmol/L calcium peritoneal dialysis solution bag | 92935 | Medicine | A | 6/20/2003 | |
| MOVICOL JUNIOR CHOCOLATE FLAVOUR powder for oral solution sachet | 207698 | Medicine | A | 4/3/2013 | |
| HEMOSOL B0 haemofiltration / haemodiafiltration solution bag | 260992 | Medicine | A | 12/14/2016 | |
| MACROVIC FLAVOURED JUNIOR powder for oral solution sachet | 220580 | Medicine | A | 2/27/2014 | |
| Hydralyte Orange Electrolyte Powder (Tub) | 292256 | Medicine | A | 7/31/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ACID CONCENTRATE RZ119C | genpharm ulc | N/A | Liquid - Haemodialysis | 263 G / L | 12/31/1995 |
| ACID CONCENTRATE RO4137 | genpharm ulc | N/A | Liquid - Haemodialysis | 226 G / L | 12/31/1995 |
| SINIX | terra botanica products ltd. | 02233367 | Liquid - Oral | 30 X | 5/25/1998 |
| SALINE NASAL MIST - LIQ NAS - 0.90% | wes pak products ltd. | 02186039 | Liquid - Nasal | .9 % | 1/14/1998 |
| 4.25% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 10% DEXTROSE | baxter corporation clintec nutrition division | N/A | Solution - Intravenous | 77 MG / 100 ML | 12/31/1996 |
| SB 1000 | renal systems, division of minntech corp. | 00678783 | Liquid - Haemodialysis | 172.2 G / L | 12/31/1985 |
| 5% DEXTROSE AND 0.45% SODIUM CHLORIDE | ICU Medical Canada Inc | 00038903 | Solution - Intravenous | 4.5 MG / ML | 12/31/1951 |
| ACID CONCENTRATE RZ254C | genpharm ulc | 02178389 | Liquid - Haemodialysis | 263 G / L | 12/31/1995 |
| POTASSIUM CHLORIDE 40 MEQ IN 5% DEXTROSE AND 0.45% SODIUM CHLORIDE | ICU Medical Canada Inc | 00603244 | Solution - Intravenous | 0.45 G / 100 ML | 12/31/1983 |
| ACID CONCENTRATE D12303 | althin biopharm inc. | 02217627 | Liquid - Haemodialysis | 263 G / L | 12/31/1996 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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