Prescription and over-the-counter medicine
Sodium chloride
Sodium chloride is a prescription and over-the-counter medicine with an FDA approval on record since 1970. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.0887 per mL (Sodium chloride 0.9% vial) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $1.06 per mL (Muro-128 2% eye drops).
- Generic listed
- A presentation discontinued
Check it at the source: the sodium chloride FDA label on DailyMed (effective June 30, 2025, Baxter Healthcare Corporation); the NDA 16733 record on Drugs@FDA; every sodium chloride label on DailyMed.
Highlights of the record
FDA label of June 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSodium Chloride Injection, USP is indicated as a source of water and electrolytes.
Forms and strengths
- 0.45 g/100ml
- 0.9 g/100ml
- 0.9 mg/ml
- 2.5 meq/ml
- 3 g/100ml
- 4 meq/ml
- 4.5 g/1000ml
- 5 g/100ml
- 5.84 g/40ml
- 9 mg/ml
- 9 g/1000ml
- 225 mg/50ml
Injection (solution); injection; injection (solution) (concentrate); irrigant; solution.
On the market
- Earliest approval on file
- August 12, 1970 Sodium Chloride 0.9% In Plastic Container, B Braun; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first January 10, 1985; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 14 under generic applications, 14 under brand applications, repackagers included; 37 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.0887 per mL Sodium chloride 0.9% vial
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 77 since 2012 16 Class I among all firms' recalls; latest September 11, 2026; 13 more by firms not listed as its makers
- FAERS reports
- 78,656 through July 30, 2026
What is sodium chloride used for?
From the label: indications and usageSodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.
Conditions named in the indications of sodium chloride's FDA labels, with every medicine labeled for each:
From other sodium chloride labelsCough and cold: Uses Moisturizing dry nasal passages and relieves nasal dryness associated with colds, allergies, sinusitis or dry air.
FDA pharmacologic class: Osmotic Laxative.
Source: FDA drug label (SODIUM CHLORIDE), Baxter Healthcare Corporation, effective June 30, 2025 (SPL set 958d35f0-6834-43be-a700-fa58f38b4c19), via openFDA; the full label on DailyMed
Is there a generic for sodium chloride?
The FDA approved the first generic sodium chloride on January 10, 1985. 19 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sodium chloride from 14 labelers under a generic (ANDA) application and from 14 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1970 earliest approval on file
- 1985 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sodium chloride?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0887 per mL (Sodium chloride 0.9% vial), up 7% from $0.083 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sodium chloride 0.9% vial (generic)
- Muro-128 2% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bacteriostatic saline vial | Generic | $0.0673 per mL | n/a | n/a |
| Sodium chloride 0.9% solution | Generic | $0.0021 per mL | n/a | -92% |
| Sodium chloride 0.9% vial | Generic | $0.0887 per mL | n/a | +7% |
| Sodium chloride 1 g tablet | Generic | $0.0682 per tablet | $2.05 | +11% |
| Sodium chloride 5% eye drop | Generic | $0.329 per mL | n/a | +18% |
| Sodium chloride 5% eye ointment | Generic | $2.99 per gram | n/a | +8% |
| Muro-128 2% eye drops | Brand | $1.06 per mL | n/a | no change |
| Muro-128 5% eye drops | Brand | $1.12 per mL | n/a | -0.2% |
| Muro-128 5% eye ointment | Brand | $4.79 per gram | n/a | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is sodium chloride in shortage?
No sodium chloride presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated December 3, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Sodium Chloride 0.9%, Injection, 100 mL ADD-Vantage® Flexible Container (NDC 0409-7101-67) | Hospira, Inc., a Pfizer Company | To Be Discontinued | December 3, 2025 |
| Sodium Chloride 0.9%, Injection, 250 mL ADD-Vantage® Flexible Container (NDC 0409-7101-02) | Hospira, Inc., a Pfizer Company | To Be Discontinued | December 3, 2025 |
| Sodium Chloride 0.9%, Injection, 50 mL ADD-Vantage® Flexible Container (NDC 0409-7101-66) | Hospira, Inc., a Pfizer Company | To Be Discontinued | December 3, 2025 |
Every sodium chloride presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has sodium chloride been recalled?
The FDA's Enforcement Report lists 90 recalls naming sodium chloride since 2012: 16 Class I (the most serious), 70 Class II, 3 Class III; 31 still ongoing. 13 of them are by firms that FDA's NDC Directory does not list as a maker of sodium chloride and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 11, 2026 | Not Yet Classified | Otsuka ICU Medical LLC | Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP … |
| August 20, 2026 | Class II | Sterling Pharmaceutical Services LLC not a listed maker | Lack of Assurance of Sterility |
| August 19, 2026 | Class I | B BRAUN MEDICAL INC | Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene |
| August 17, 2026 | Class I | Baxter Healthcare Corporation | Presence of particulate matter: Particulates identified as fiberglass |
| April 2, 2026 | Class II | B BRAUN MEDICAL INC | Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. |
| April 2, 2026 | Class II | Huons Co., Ltd. | Lack of Assurance of Sterility |
| March 11, 2026 | Class II | Fresenius Kabi USA, LLC | Lack of Assurance of Sterility |
| October 27, 2025 | Class II | Otsuka ICU Medical LLC | Lack of Assurance of Sterility: Potential for flexible container leaks. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sodium chloride label say about other medicines?
The sodium chloride label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Corticotropin | drug interactions | Avoid use of Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. |
| Lithium | drug interactions | Lithium Renal sodium and lithium clearance may be decreased during administration of Sodium Chloride Injection, USP. |
Source: FDA drug label (SODIUM CHLORIDE), Baxter Healthcare Corporation, effective June 30, 2025 (SPL set 958d35f0-6834-43be-a700-fa58f38b4c19), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium chloride?
The FDA Adverse Event Reporting System holds 78,656 reports that list sodium chloride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,849 are coded as a death and 35,162 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other osmotic laxatives
- the pharmacologic class, with prices and generics
- Sodium chloride side effects
- the label's list beside FAERS reports
- Sodium chloride shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other