adverse reactions
ADVERSE REACTIONS The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
METRONIDAZOLE
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
- METRONIDAZOLE
- Generic name
- METRONIDAZOLE TOPICAL
- Manufacturer
- Encube Ethicals, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 05707735-e676-412a-9a77-ebd003afb16c
- SPL ID
- a0c70ee2-3ac6-4610-8592-642fd2d1aafc
- Version
- 2
- Effective date
- 2025-09-12
- 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 02:54:16
| Harmonized routes |
|---|
| TOPICAL |
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 | 077547 | derived:openfda.application_number |
| application number | ANDA077547 | openfda.application_number | |
| brand name | METRONIDAZOLE | openfda.brand_name | |
| generic name | METRONIDAZOLE TOPICAL | openfda.generic_name | |
| manufacturer name | Encube Ethicals, Inc. | openfda.manufacturer_name | |
| ndc | package | 21922-070-06 | openfda.package_ndc |
| ndc | product | 21922-070 | openfda.product_ndc |
| ndc11 | package | 21922007006 | derived:openfda.package_ndc |
| rxcui | 311679 | openfda.rxcui | |
| spl id | a0c70ee2-3ac6-4610-8592-642fd2d1aafc | id | |
| spl set id | 05707735-e676-412a-9a77-ebd003afb16c | set_id | |
| unii | 140QMO216E | openfda.unii |
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.