warnings
WARNINGS Flavoxate HCl should be given cautiously in patients with suspected glaucoma.
FLAVOXATE HYDROCHLORIDE
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
- FLAVOXATE HYDROCHLORIDE
- Generic name
- FLAVOXATE HYDROCHLORIDE
- Manufacturer
- Padagis US LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5
- SPL ID
- ff1c0ee9-75d2-478a-9152-0753be81ff11
- Version
- 12
- Effective date
- 2023-05-31
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:25:29
| Harmonized routes |
|---|
| ORAL |
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 | ANDA | 076831 | derived:openfda.application_number |
| application number | ANDA076831 | openfda.application_number | |
| brand name | FLAVOXATE HYDROCHLORIDE | openfda.brand_name | |
| generic name | FLAVOXATE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Padagis US LLC | openfda.manufacturer_name | |
| ndc | package | 0574-0115-01 | openfda.package_ndc |
| ndc | product | 0574-0115 | openfda.product_ndc |
| ndc11 | package | 00574011501 | derived:openfda.package_ndc |
| rxcui | 1095229 | openfda.rxcui | |
| spl id | ff1c0ee9-75d2-478a-9152-0753be81ff11 | id | |
| spl set id | a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5 | set_id | |
| unii | 9C05J6089W | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Gastrointestinal: Nausea, vomiting, dry mouth. CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness. Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug). Cardiovascular: Tachycardia and palpitation. Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia. Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation. Renal: Dysuria.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.