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: Cosette Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 86da8d86-5ab2-f668-fdfd-b0e93e6a2245
SPL ID: edf61c59-f083-6b15-e053-2995a90a675b
Version: 10
Effective date: 2022-11-21
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:30:56

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	078178	derived:openfda.application_number
application number		ANDA078178	openfda.application_number
brand name		Metronidazole	openfda.brand_name
generic name		METRONIDAZOLE	openfda.generic_name
manufacturer name		Cosette Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	0713-0637-37	openfda.package_ndc
ndc	product	0713-0637	openfda.product_ndc
ndc11	package	00713063737	derived:openfda.package_ndc
rxcui		311679	openfda.rxcui
spl id		edf61c59-f083-6b15-e053-2995a90a675b	id
spl set id		86da8d86-5ab2-f668-fdfd-b0e93e6a2245	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. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 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.