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: A-S Medication Solutions
Product type: HUMAN OTC DRUG
SPL set ID: 23ca78c0-16a9-455c-99a7-b9a9a3affa60
SPL ID: ee050e57-7737-4209-ac6c-a3b85a85c0e6
Version: 3
Effective date: 2025-12-03
Source export date: 2026-11-06
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/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:55:24

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		A-S Medication Solutions	openfda.manufacturer_name
ndc	package	50090-7364-0	openfda.package_ndc
ndc	product	50090-7364	openfda.product_ndc
ndc11	package	50090736400	derived:openfda.package_ndc
rxcui		998483	openfda.rxcui
spl id		ee050e57-7737-4209-ac6c-a3b85a85c0e6	id
spl set id		23ca78c0-16a9-455c-99a7-b9a9a3affa60	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 less than 2 years of age unless directed by a doctor When using this product avoid contact with eyes Stop use and ask a doctor if irritation occurs condition persists there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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