Prescription medicine
Dextrose and potassium chloride and sodium chloride
Dextrose and potassium chloride and sodium chloride is a prescription medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the dextrose and potassium chloride and sodium chloride FDA label on DailyMed (effective November 2, 2025, ICU Medical Inc.); the NDA 18008 record on Drugs@FDA; every dextrose and potassium chloride and sodium chloride label on DailyMed.
Highlights of the record
FDA label of November 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageThese solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.
Forms and strengths
- 5 g/100ml / 0.45 g/100ml / 0.3 g/100ml
- 5 g/100ml / 0.45 g/100ml / 0.075 g/100ml
- 5 g/100ml / 0.9 g/100ml / 0.15 g/100ml
- 5 g/100ml / 0.2 g/100ml / 0.15 g/100ml
- 5 g/100ml / 0.45 g/100ml / 0.15 g/100ml
- 5 g/100ml / 0.45 g/100ml / 0.22 g/100ml
- 25 g/500ml / 2.25 g/500ml / 0.745 g/500ml
- 50 g/1000ml / 2.25 g/1000ml / 1.49 g/1000ml
- 50 g/1000ml / 4.5 g/1000ml / 2.24 g/1000ml
- 50 g/1000ml / 9 g/1000ml / 1.49 g/1000ml
- 50 g/1000ml / 4.5 g/1000ml / 0.745 g/1000ml
- 50 g/1000ml / 9 g/1000ml / 2.98 g/1000ml
Injection (solution); injection.
On the market
- Earliest approval on file
- February 2, 1979 Potassium Chloride 30Meq In Dextrose 5% And Sodium Chloride 0.45% In Plastic Container, Baxter Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first March 9, 2021; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 1 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
- 43 through July 30, 2026
What is dextrose and potassium chloride and sodium chloride used for?
From the label: indications and usageThese solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.
FDA pharmacologic class: Osmotic Laxative and Potassium Salt.
Source: FDA drug label (Potassium Chloride in Dextrose and Sodium Chloride), NDA019691 (Otsuka Icu Medcl), as published by ICU Medical Inc., effective November 2, 2025 (SPL set d8ee14e9-6733-4813-9f21-2b043a5f7188), via openFDA; the full label on DailyMed
Is there a generic for dextrose and potassium chloride and sodium chloride?
The FDA approved the first generic dextrose and potassium chloride and sodium chloride on March 9, 2021. 3 generic applications are approved; 3 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 dextrose and potassium chloride and sodium chloride from 1 labeler 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
- 2021 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the dextrose and potassium chloride and sodium chloride label say about other medicines?
The dextrose and potassium chloride and sodium chloride label names 4 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 | warnings and precautions | Medications such as corticosteroids or corticotropin, may increase the risk of sodium and fluid retention. Avoid in patients with or at risk for hypernatremia. |
| Digoxin | warnings and precautions | • with severe renal impairment, acute dehydration, extensive tissue injury or burns, and certain cardiac disorders such as congestive heart failure or AV block (especially if they receive digoxin). |
| Lithium | drug interactions | Decreased lithium concentrations with concomitant use; monitor serum lithium concentrations. |
| Thiamine | warnings and precautions | Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increasing nutrient intake. |
Check dextrose and potassium chloride and sodium chloride against other medicines
Source: FDA drug label (Potassium Chloride in Dextrose and Sodium Chloride), NDA019691 (Otsuka Icu Medcl), as published by ICU Medical Inc., effective November 2, 2025 (SPL set d8ee14e9-6733-4813-9f21-2b043a5f7188), via openFDA; the full label on DailyMed
What do FAERS reports show for dextrose and potassium chloride and sodium chloride?
The FDA Adverse Event Reporting System holds 43 reports that list dextrose and 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; 17 are coded as a death and 9 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
- Dextrose and 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