Quick answers
- What is Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride used for?
- The FDA-approved label (Normosol-R, ICU Medical Inc., October 30, 2025) says: “Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride?
- 4 companies list prescription products of Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride in the FDA NDC Directory, including Fresenius Kabi USA, LLC, B. Braun Medical Inc. and ICU Medical Inc..
What Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. …
— FDA label: Normosol-R, ICU Medical Inc., effective October 30, 2025. Read the full label on DailyMed →
The FDA has 6 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 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Irrigant |
|---|---|
| Route | Intravenous · Irrigation |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | Normosol-R, Multiple Electrolytes Ph 7.4, Plasma-Lyte a, Isolyte S, Physiolyte, Multiple Electrolytes Ph 5.5 |
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, LLC2 products
- B. Braun Medical Inc.2 products
- ICU Medical Inc.2 products
- Baxter Healthcare Corporation1 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 |
|---|---|---|---|
| NDA017378 PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, PLASMA-LYTE A IN PLASTIC CONTAINER | Baxter Hlthcare | February 2, 1979 | 55, latest August 5, 2019 2019: Labeling · 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
| NDA017586 NORMOSOL-R IN PLASTIC CONTAINER | Otsuka Icu Medcl | August 13, 1975 | 96, latest March 22, 2016 2016: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2000: Labeling |
| NDA019024 PHYSIOLYTE IN PLASTIC CONTAINER | B Braun | June 8, 1984 | 13, latest May 8, 2013 2013: Manufacturing (CMC) · 2003: Labeling · 2002: Manufacturing (CMC) |
| NDA019711 ISOLYTE S IN PLASTIC CONTAINER | B Braun | September 29, 1989 | 15, latest February 19, 2004 2004: Labeling · 2002: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
Generic approvals (2)
- ANDA215371Fresenius Kabi USA · June 8, 2022
- ANDA215370Fresenius Kabi USA · June 29, 2022
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) | 800985, 800988, 801109, 801112, 827351, 827353 |
|---|---|
| SPL set ID of the quoted label | 0e089a44-0cee-4804-8f6f-8508508ddb5c |
| FDA labels (SPL) | 6 |
| FDA applications | NDA017378, NDA017586, NDA019024, NDA019711, 2 ANDA |
| Active ingredients (FDA) | MAGNESIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM ACETATE / SODIUM CHLORIDE / SODIUM GLUCONATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Normosol-R, ICU Medical Inc., effective October 30, 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 →