Quick answers
- What is Dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride used for?
- The FDA-approved label (Normosol-R and Dextrose, ICU Medical Inc., October 30, 2025) says: “Normosol-R and 5% Dextrose Injection is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R and 5% Dextrose 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 Dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, 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 Dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, 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 Dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride?
- 1 company lists prescription products of Dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride in the FDA NDC Directory, including ICU Medical Inc..
What Dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Normosol-R and 5% Dextrose Injection is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R and 5% Dextrose also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. …
— FDA label: Normosol-R and Dextrose, ICU Medical Inc., effective October 30, 2025. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Normosol-R and Dextrose |
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.
- ICU Medical Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017609 NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER | Otsuka Icu Medcl | August 13, 1975 | 98, latest September 5, 2013 2013: Manufacturing (CMC) · 2000: Labeling · 2000: Labeling |
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) | 801024, 1189629 |
|---|---|
| SPL set ID of the quoted label | ead1fca3-eff4-478f-8a8f-67510f80151a |
| FDA labels (SPL) | 1 |
| FDA applications | NDA017609 |
| Active ingredients (FDA) | DEXTROSE MONOHYDRATE / MAGNESIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM ACETATE ANHYDROUS / SODIUM CHLORIDE / SODIUM GLUCONATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Normosol-R and Dextrose, 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 →