warnings
WARNINGS Large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.
Methenamine Hippurate
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
- Methenamine Hippurate
- Generic name
- METHENAMINE HIPPURATE
- Manufacturer
- American Health Packaging
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- fcb9b18a-6e6d-42c7-bc85-c61cb1c4a3be
- SPL ID
- 22ddc289-92bd-d459-e063-6394a90af811
- Version
- 2
- Effective date
- 2024-09-24
- Source export date
- 2026-10-12
- 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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:52:25
| 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 | 212172 | derived:openfda.application_number |
| application number | ANDA212172 | openfda.application_number | |
| brand name | Methenamine Hippurate | openfda.brand_name | |
| generic name | METHENAMINE HIPPURATE | openfda.generic_name | |
| manufacturer name | American Health Packaging | openfda.manufacturer_name | |
| ndc | package | 60687-694-21 | openfda.package_ndc |
| ndc | package | 60687-694-11 | openfda.package_ndc |
| ndc | product | 60687-694 | openfda.product_ndc |
| ndc11 | package | 60687069421 | derived:openfda.package_ndc |
| ndc11 | package | 60687069411 | derived:openfda.package_ndc |
| rxcui | 992150 | openfda.rxcui | |
| spl id | 22ddc289-92bd-d459-e063-6394a90af811 | id | |
| spl set id | fcb9b18a-6e6d-42c7-bc85-c61cb1c4a3be | set_id | |
| unii | M329791L57 | 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 Minor adverse reactions have been reported in less than 3.5% of patients treated. These reactions have included nausea, upset stomach, dysuria, and rash. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.