Acetic Acid
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
- Acetic Acid
- Generic name
- ACETIC ACID
- Manufacturer
- B. Braun Medical Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- dd45cee3-9938-4dad-a5e1-1dd4baea85a9
- SPL ID
- ab98b143-e9d6-4869-9abf-708ec1004f57
- Version
- 7
- Effective date
- 2023-08-23
- Source export date
- 2026-09-28
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:03:21
| 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 | 018161 | derived:openfda.application_number |
| application number | NDA018161 | openfda.application_number | |
| brand name | Acetic Acid | openfda.brand_name | |
| generic name | ACETIC ACID | openfda.generic_name | |
| manufacturer name | B. Braun Medical Inc. | openfda.manufacturer_name | |
| ndc | package | 0264-2304-10 | openfda.package_ndc |
| ndc | package | 0264-2304-00 | openfda.package_ndc |
| ndc | product | 0264-2304 | openfda.product_ndc |
| ndc11 | package | 00264230410 | derived:openfda.package_ndc |
| ndc11 | package | 00264230400 | derived:openfda.package_ndc |
| rxcui | 307707 | openfda.rxcui | |
| spl id | ab98b143-e9d6-4869-9abf-708ec1004f57 | id | |
| spl set id | dd45cee3-9938-4dad-a5e1-1dd4baea85a9 | set_id | |
| unii | Q40Q9N063P | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS FOR UROLOGIC IRRIGATION ONLY. NOT FOR INJECTION. Use of this solution in patients with mucosal lesions of the urinary bladder may be harmful due to irritation of the lesion. Absorption via open lesions of the bladder mucosa may result in systemic acidosis. Do not warm above 150°F (66°C). After opening container, the contents should be used promptly in order to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservative.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Systemic acidosis, pain, and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid solution. If an adverse reaction does occur, discontinue administration of 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.