warnings
WARNINGS Flavoxate hydrochloride 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
- Epic Pharma, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- b4260d7e-2ab3-49f6-aa57-bae19a23d82a
- SPL ID
- 6aeb8856-3df7-40a7-b03e-d855a58c8fa4
- Version
- 11
- Effective date
- 2023-12-27
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:32:04
| 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 | 076835 | derived:openfda.application_number |
| application number | ANDA076835 | openfda.application_number | |
| brand name | Flavoxate Hydrochloride | openfda.brand_name | |
| generic name | FLAVOXATE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Epic Pharma, LLC | openfda.manufacturer_name | |
| ndc | package | 42806-058-10 | openfda.package_ndc |
| ndc | package | 42806-058-01 | openfda.package_ndc |
| ndc | product | 42806-058 | openfda.product_ndc |
| ndc11 | package | 42806005810 | derived:openfda.package_ndc |
| ndc11 | package | 42806005801 | derived:openfda.package_ndc |
| rxcui | 1095229 | openfda.rxcui | |
| spl id | 6aeb8856-3df7-40a7-b03e-d855a58c8fa4 | id | |
| spl set id | b4260d7e-2ab3-49f6-aa57-bae19a23d82a | 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.