Sorbitol-Mannitol
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Sorbitol-Mannitol
- Generic name
- SORBITOL AND MANNITOL
- Manufacturer
- ICU Medical Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 5b44e248-4b7b-4777-954a-921c7b309944
- SPL ID
- fba5680c-d4e6-461a-95e3-25edd33ba39c
- Version
- 8
- Effective date
- 2025-10-30
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:28:16
| Harmonized routes |
|---|
| URETHRAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 018316 | derived:openfda.application_number |
| application number | NDA018316 | openfda.application_number | |
| brand name | Sorbitol-Mannitol | openfda.brand_name | |
| generic name | SORBITOL AND MANNITOL | openfda.generic_name | |
| manufacturer name | ICU Medical Inc. | openfda.manufacturer_name | |
| ndc | package | 0990-7981-08 | openfda.package_ndc |
| ndc | product | 0990-7981 | openfda.product_ndc |
| ndc11 | package | 00990798108 | derived:openfda.package_ndc |
| rxcui | 311446 | openfda.rxcui | |
| spl id | fba5680c-d4e6-461a-95e3-25edd33ba39c | id | |
| spl set id | 5b44e248-4b7b-4777-954a-921c7b309944 | set_id | |
| unii | 506T60A25R | openfda.unii | |
| unii | 3OWL53L36A | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS FOR UROLOGIC IRRIGATION ONLY. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes; thus, sorbitol-mannitol irrigant must be regarded as a systemic drug. Absorption of large amounts of fluids containing sorbitol-mannitol and the osmotic diuresis it produces may significantly alter cardiopulmonary and renal dynamics. Hyperglycemia from metabolism of sorbitol may occur in patients with diabetes mellitus. Hyperlactatemia from metabolism of sorbitol may potentially produce a significant lactic acidemia in metabolically compromised patients. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigation solution since it contains no preservatives. Do not heat over 66°C (150°F).
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse reactions may result from intravascular absorption of sorbitol and mannitol. The literature reports occasional adverse reactions from intravenous sorbitol-mannitol infusions. Consequences of absorption of urologic irrigating solutions include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst and dehydration; cardiovascular disorders such as hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary congestion; and other general reactions such as blurred vision, convulsions, nausea, vomiting, diarrhea, rhinitis, chills, vertigo, backache and urticaria. Allergic reactions from sorbitol-mannitol have also been reported. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.