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 (canonical bytes are SHA-256 checked before publication)

Brand name: Metronidazole
Generic name: METRONIDAZOLE
Manufacturer: Viona Pharmaceuticals Inc
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 40a8c59b-a46d-4e5b-bd38-330cdbc1022c
SPL ID: 90a3bb34-53e8-4f44-b583-e30f0e2b8727
Version: 1
Effective date: 2026-02-19
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 05:25:56

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	220095	derived:openfda.application_number
application number		ANDA220095	openfda.application_number
brand name		Metronidazole	openfda.brand_name
generic name		METRONIDAZOLE	openfda.generic_name
manufacturer name		Viona Pharmaceuticals Inc	openfda.manufacturer_name
ndc	package	72578-209-04	openfda.package_ndc
ndc	product	72578-209	openfda.product_ndc
ndc11	package	72578020904	derived:openfda.package_ndc
rxcui		311679	openfda.rxcui
spl id		90a3bb34-53e8-4f44-b583-e30f0e2b8727	id
spl set id		40a8c59b-a46d-4e5b-bd38-330cdbc1022c	set_id
unii		140QMO216E	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

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. T o report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 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.