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: Mayne Pharma Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 567c7c0c-ffc1-47c1-b0fb-8715bf3d76b9
SPL ID: 944575da-eb42-40dc-9dfe-8ee02bba38f1
Version: 1
Effective date: 2024-10-31
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:03:34

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	NDA	020531	derived:openfda.application_number
application number		NDA020531	openfda.application_number
brand name		METRONIDAZOLE	openfda.brand_name
generic name		METRONIDAZOLE	openfda.generic_name
manufacturer name		Mayne Pharma Inc.	openfda.manufacturer_name
ndc	package	68308-711-45	openfda.package_ndc
ndc	product	68308-711	openfda.product_ndc
ndc11	package	68308071145	derived:openfda.package_ndc
rxcui		311678	openfda.rxcui
spl id		944575da-eb42-40dc-9dfe-8ee02bba38f1	id
spl set id		567c7c0c-ffc1-47c1-b0fb-8715bf3d76b9	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: In controlled clinical trials, the total incidence of adverse reactions associated with the use of Metronidazole Topical Cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.