Quick answers
- What is Sodium chloride and potassium chloride used for?
- The FDA-approved label (Potassium Chloride in Sodium Chloride, ICU Medical Inc., November 2, 2025) says: “These solutions are indicated in patients requiring parenteral administration of potassium chloride and sodium chloride.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium chloride and potassium chloride have a boxed warning?
- No. None of the 5 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sodium chloride and potassium chloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sodium chloride and potassium chloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sodium chloride and potassium chloride?
- 4 companies list prescription products of Sodium chloride and potassium chloride in the FDA NDC Directory, including Fresenius Kabi USA, LLC, ICU Medical Inc. and Baxter Healthcare Company.
What Sodium chloride and potassium chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
These solutions are indicated in patients requiring parenteral administration of potassium chloride and sodium chloride.
— FDA label: Potassium Chloride in Sodium Chloride, ICU Medical Inc., effective November 2, 2025. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Solution |
|---|---|
| Route | Intravenous |
| Prescription products | 10 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fresenius Kabi USA, LLC3 products
- ICU Medical Inc.3 products
- Baxter Healthcare Company3 products
- B. Braun Medical Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017648 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%, POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% | Baxter Hlthcare | February 2, 1979 | 52, latest January 11, 2019 2019: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA019686 POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Otsuka Icu Medcl | October 17, 1988 | 11, latest September 10, 2015 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 1999: Labeling |
| NDA019708 POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | B Braun | September 29, 1989 | 14, latest January 17, 2026 2026: Labeling · 2014: Manufacturing (CMC) · 2005: Labeling |
Generic approvals (2)
- ANDA078446Otsuka Icu Medcl · September 10, 2008
- ANDA212347Fresenius Kabi USA · September 17, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 237367, 403890, 637551 |
|---|---|
| SPL set ID of the quoted label | 9dd1c001-73b3-41d4-9a96-61f6ad3a5dc3 |
| FDA labels (SPL) | 5 |
| FDA applications | NDA017648, NDA019686, NDA019708, 2 ANDA |
| Active ingredients (FDA) | POTASSIUM CHLORIDE / SODIUM CHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Potassium Chloride in Sodium Chloride, ICU Medical Inc., effective November 2, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →