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Prescription medicine

Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate used for?
The FDA-approved label (Tis-U-Sol, Baxter Healthcare Corporation, February 21, 2014) says: “Isotonic solution for irrigation only. Not for injection.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate 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 Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate?
1 company lists prescription products of Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate in the FDA NDC Directory, including Baxter Healthcare Corporation.

What Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Isotonic solution for irrigation only. Not for injection.

— FDA label: Tis-U-Sol, Baxter Healthcare Corporation, effective February 21, 2014. 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 formsIrrigant
RouteIrrigation
Prescription products1 in the FDA NDC Directory
Brand namesTis-U-Sol

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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA018508
TIS-U-SOL
Baxter HlthcareFebruary 19, 1982 13, latest June 26, 2015
2015: Manufacturing (CMC) · 2015: Manufacturing (CMC) · 2011: Manufacturing (CMC)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)801442, 801445
SPL set ID of the quoted label9da4121f-d62d-4da4-8dfb-0494da16015f
FDA labels (SPL)1
FDA applicationsNDA018508
Active ingredients (FDA)MAGNESIUM SULFATE HEPTAHYDRATE / MONOBASIC POTASSIUM PHOSPHATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Tis-U-Sol, Baxter Healthcare Corporation, effective February 21, 2014; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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