Prescription medicine
Potassium chloride and sodium chloride
Potassium chloride and sodium chloride is a prescription medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the potassium chloride and sodium chloride FDA label on DailyMed (effective January 11, 2019, Baxter Healthcare Company); the NDA 17648 record on Drugs@FDA; every potassium chloride and sodium chloride label on DailyMed.
Highlights of the record
FDA label of January 11, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePotassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
Forms and strengths
- 0.9 g/100ml / 0.15 g/100ml
- 4.5 g/1000ml / 1.49 g/1000ml
- 9 g/1000ml / 2.98 g/1000ml
- 9 g/1000ml / 1.49 g/1000ml
- 450 mg/100ml / 150 mg/100ml
- 900 mg/100ml / 150 mg/100ml
- 900 mg/100ml / 300 mg/100ml
Injection (solution); solution.
On the market
- Earliest approval on file
- February 2, 1979 Sodium Chloride 0.9% And Potassium Chloride 0.075%, Baxter Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first September 10, 2008; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 2 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 63 through July 30, 2026
What is potassium chloride and sodium chloride used for?
From the label: indications and usagePotassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
FDA pharmacologic class: Osmotic Laxative and Potassium Salt.
Source: FDA drug label (Potassium Chloride in Sodium Chloride), Baxter Healthcare Company, effective January 11, 2019 (SPL set becc7410-0a25-49f5-b0c3-240078479dc8), via openFDA; the full label on DailyMed
Is there a generic for potassium chloride and sodium chloride?
The FDA approved the first generic potassium chloride and sodium chloride on September 10, 2008. 2 generic applications are approved; 2 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 potassium chloride and sodium chloride from 2 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1979 earliest approval on file
- 2008 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the potassium chloride and sodium chloride label say about other medicines?
The potassium chloride and sodium chloride label names 5 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 Potassium Chloride in Sodium Chloride Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. |
| Cyclosporine | drug interactions | Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients receiving such products (e.g., potassium sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or the immunosuppressants cyclosporine and tacrolimus). |
| Digoxin | warnings | … cardiac disorders such as congestive heart failure or atrioventricular (AV) block (especially if they receive digoxin). |
| Lithium | drug interactions | Drug Interactions Lithium Renal sodium and lithium clearance may be increased during administration of Potassium Chloride in Sodium Chloride Injection, USP and result in decreased lithium concentrations. |
| Tacrolimus | drug interactions | Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients receiving such products (e.g., potassium sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or the immunosuppressants cyclosporine and tacrolimus). |
Check potassium chloride and sodium chloride against other medicines
Source: FDA drug label (Potassium Chloride in Sodium Chloride), Baxter Healthcare Company, effective January 11, 2019 (SPL set becc7410-0a25-49f5-b0c3-240078479dc8), via openFDA; the full label on DailyMed
What do FAERS reports show for potassium chloride and sodium chloride?
The FDA Adverse Event Reporting System holds 63 reports that list potassium chloride and sodium chloride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 35 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.
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
- Potassium chloride and sodium chloride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other