Miconazole Nitrate

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: Miconazole Nitrate
Generic name: MICONAZOLE NITRATE
Manufacturer: AvKARE
Product type: HUMAN OTC DRUG
SPL set ID: 1a26534d-eeb8-8d17-e063-6294a90a70c7
SPL ID: 48c0e508-e6c0-3d43-e063-6294a90a3ade
Version: 2
Effective date: 2026-01-19
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:35:13

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		Miconazole Nitrate	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		AvKARE	openfda.manufacturer_name
ndc	package	42291-938-85	openfda.package_ndc
ndc	product	42291-938	openfda.product_ndc
ndc11	package	42291093885	derived:openfda.package_ndc
rxcui		998461	openfda.rxcui
spl id		48c0e508-e6c0-3d43-e063-6294a90a3ade	id
spl set id		1a26534d-eeb8-8d17-e063-6294a90a70c7	set_id
unii		VW4H1CYW1K	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings for external use only Do not use on children under 2 years of age unless by a doctor avoid contact with the eyes for athlete's foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor for jock itch - if irritation occurs, or if there is no improvement within 2 weeks, dicontinue use and consult a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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