Renacidin
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
- Renacidin
- Generic name
- CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE
- Manufacturer
- United-Guardian, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 13a9bbba-db21-4cba-991c-5d8afaf2ed74
- SPL ID
- 73bb8d15-8d5c-426c-b42f-504a5da9cb8e
- Version
- 3
- Effective date
- 2019-12-17
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:43:46
| Harmonized routes |
|---|
| IRRIGATION |
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 | 019481 | derived:openfda.application_number |
| application number | NDA019481 | openfda.application_number | |
| brand name | Renacidin | openfda.brand_name | |
| generic name | CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE | openfda.generic_name | |
| manufacturer name | United-Guardian, Inc. | openfda.manufacturer_name | |
| ndc | package | 0327-0012-30 | openfda.package_ndc |
| ndc | product | 0327-0012 | openfda.product_ndc |
| ndc11 | package | 00327001230 | derived:openfda.package_ndc |
| rxcui | 1792396 | openfda.rxcui | |
| rxcui | 1792398 | openfda.rxcui | |
| spl id | 73bb8d15-8d5c-426c-b42f-504a5da9cb8e | id | |
| spl set id | 13a9bbba-db21-4cba-991c-5d8afaf2ed74 | set_id | |
| unii | WQ29KQ9POT | openfda.unii | |
| unii | 0E53J927NA | openfda.unii | |
| unii | XF417D3PSL | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Renacidin use should be stopped immediately if the patient develops fever, urinary tract infection, signs and symptoms consistent with urinary tract infection, or persistent flank pain. Irrigation should be stopped if elevated serum creatinine develops. The contents of individual Renacidin containers should not be combined for use as continuous irrigation of the urinary tract because of complications that may arise from inadequate aseptic technique. Terminal sterilization processes that are not adequate may result in sepsis and/or injury to product handlers (e.g., irritation to exposed, unprotected areas of the skin). Serious adverse reactions, including sepsis and hypermagnesemia, have been reported to occur when Renacidin was used for continuous irrigation of the upper urinary tract. Renacidin is not indicated for continuous irrigation of the upper urinary tract.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The most common adverse reactions with use of Renacidin for dissolution of bladder calculi or prevention of encrustations of indwelling urethral catheters are “bladder irritability” and chemical cystitis, both reported to occur in approximately 3% of patients. A transient burning sensation in the bladder following Renacidin has been reported to occur in less than 1% of patients receiving Renacidin.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.