Antifungal

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: Antifungal
Generic name: MICONAZOLE NITRATE
Manufacturer: Advanced Rx LLC
Product type: HUMAN OTC DRUG
SPL set ID: e13eb653-3916-444a-ae86-1738c0308b79
SPL ID: 3af71de6-43f9-b1a2-e063-6394a90a5050
Version: 1
Effective date: 2025-07-28
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 06:55:07

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		Antifungal	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		Advanced Rx LLC	openfda.manufacturer_name
ndc	package	80513-771-03	openfda.package_ndc
ndc	product	80513-771	openfda.product_ndc
ndc11	package	80513077103	derived:openfda.package_ndc
rxcui		998461	openfda.rxcui
spl id		3af71de6-43f9-b1a2-e063-6394a90a5050	id
spl set id		e13eb653-3916-444a-ae86-1738c0308b79	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 directed by a doctor. When using this product avoid contact with the eyes. Stop and ask a doctor if for athlete’s foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks for jock itch - if irritation occurs, or if there is no improvement within 2 weeks 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.