Quick answers
- What is Physiolyte?
- Physiolyte is a brand name of Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride, a prescription medicine. The FDA NDC Directory lists 1 Physiolyte product in 1 strength and form.
- Who makes Physiolyte?
- B Braun holds the FDA application for Physiolyte (NDA019024, approved June 8, 1984).
- Is there a generic or store brand of Physiolyte?
- Other products of Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride are listed with the FDA, but none in exactly the same strength and form as a Physiolyte product.
- Has Physiolyte been recalled?
- No recall linked to Physiolyte products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Physiolyte is
Each Physiolyte product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| magnesium chloride 0.03% · potassium chloride 0.037% · sodium acetate 0.37% · sodium chloride 0.53% · sodium gluconate 0.5% irrigant (irrigation) | Physiolyte | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019024 | B Braun | June 8, 1984 | 1 |
Companies that list Physiolyte
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Physiolyte products.
- B. Braun Medical Inc.1 product
Recalls
No recall linked to Physiolyte products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.