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: ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE
Manufacturer: Hudson Health LLC
Product type: HUMAN OTC DRUG
SPL set ID: 8d725a50-fbe4-4a48-9cbf-f8b5c12dd647
SPL ID: 36aec48d-c3a0-70d3-e063-6394a90afb85
Version: 8
Effective date: 2025-06-03
Source export date: 2026-11-06
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 08:04:26

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		ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE	openfda.generic_name
manufacturer name		Hudson Health LLC	openfda.manufacturer_name
ndc	package	72446-007-71	openfda.package_ndc
ndc	product	72446-007	openfda.product_ndc
ndc11	package	72446000771	derived:openfda.package_ndc
rxcui		998461	openfda.rxcui
spl id		36aec48d-c3a0-70d3-e063-6394a90afb85	id
spl set id		8d725a50-fbe4-4a48-9cbf-f8b5c12dd647	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 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes Stop and ask a doctor if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

Reported adverse events (FAERS/openFDA)#

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