Prescription and over-the-counter medicine
Sodium phosphate dibasic and sodium phosphate monobasic
Sodium phosphate dibasic and sodium phosphate monobasic is a prescription and over-the-counter medicine with an FDA approval on record since 1983. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.0067 per mL (Enema ready to use) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the sodium phosphate dibasic and sodium phosphate monobasic FDA label on DailyMed (effective May 11, 2026, Hospira, Inc.); the NDA 18892 record on Drugs@FDA; every sodium phosphate dibasic and sodium phosphate monobasic label on DailyMed.
Highlights of the record
FDA label of May 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake.
Forms and strengths
- 1.105 g / 0.398 g
- 276 mg/ml / 142 mg/ml
- 276 mg/ml / 268 mg/ml
Injection (solution); tablet.
On the market
- Earliest approval on file
- May 10, 1983 Sodium Phosphates In Plastic Container, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first December 30, 2011; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 6 under generic applications, 1 under brand applications, repackagers included; 20 more under the over-the-counter monograph, without an application
- Last listed patent
- June 22, 2028 Osmoprep tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0067 per mL Enema ready to use
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2025 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 211 through July 30, 2026
What is sodium phosphate dibasic and sodium phosphate monobasic used for?
From the label: indications and usageSodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na + 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.
Conditions named in the indications of sodium phosphate dibasic and sodium phosphate monobasic's FDA labels, with every medicine labeled for each:
From other sodium phosphate dibasic and sodium phosphate monobasic labelsConstipation: Use relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes
FDA pharmacologic class: Osmotic Laxative.
Source: FDA drug label (Sodium Phosphates), Hospira, Inc., effective May 11, 2026 (SPL set 6f044d16-295e-43ff-72a3-b045c387bc5c), via openFDA; the full label on DailyMed
Is there a generic for sodium phosphate dibasic and sodium phosphate monobasic?
The FDA approved the first generic sodium phosphate dibasic and sodium phosphate monobasic on December 30, 2011. 4 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sodium phosphate dibasic and sodium phosphate monobasic from 6 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Sodium Phosphates In Plastic Container injection; a patent listed only for Osmoprep tablets runs to June 22, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1983 earliest approval on file
- 2011 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sodium phosphate dibasic and sodium phosphate monobasic?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0067 per mL (Enema ready to use), down 6% from $0.0072 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Enema ready to use (generic)
- Fleet enema (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Enema ready to use | Generic | $0.0067 per mL | n/a | -6% |
| Ft enema ready to use | Generic | $0.0067 per mL | n/a | -13% |
| Ft enema ready to use twin pak | Generic | $0.0072 per mL | n/a | +8% |
| Qc enema ready to use | Generic | $0.0067 per mL | n/a | -13% |
| Qc enema ready to use twin pak | Generic | $0.0067 per mL | n/a | -13% |
| Sm enema ready to use | Generic | $0.0067 per mL | n/a | -13% |
| Fleet enema | Brand | $0.009 per mL | n/a | +16% |
| Fleet pedia-lax enema | Brand | $0.0204 per mL | n/a | +1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sodium phosphate dibasic and sodium phosphate monobasic been recalled?
The FDA's Enforcement Report lists 1 recall naming sodium phosphate dibasic and sodium phosphate monobasic since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of sodium phosphate dibasic and sodium phosphate monobasic and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 31, 2025 | Class II | Blossom Pharmaceuticals not a listed maker | cGMP deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for sodium phosphate dibasic and sodium phosphate monobasic?
The FDA Adverse Event Reporting System holds 211 reports that list sodium phosphate dibasic and sodium phosphate monobasic among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 51 are coded as a death and 119 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other osmotic laxatives
- the pharmacologic class, with prices and generics
- Sodium phosphate dibasic and sodium phosphate monobasic side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other