Anti- Fungal 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: Anti- Fungal Miconazole Nitrate
Generic name: MICONAZOLE NITRATE
Manufacturer: Premier Brands of America Inc.
Product type: HUMAN OTC DRUG
SPL set ID: f186bdc1-db6c-0fab-e053-2995a90a7c58
SPL ID: 3bba5b9f-d184-6f93-e063-6394a90ae951
Version: 7
Effective date: 2025-08-06
Source export date: 2026-11-06
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:44:38

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		Anti- Fungal Miconazole Nitrate	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		Premier Brands of America Inc.	openfda.manufacturer_name
ndc	package	56104-253-01	openfda.package_ndc
ndc	product	56104-253	openfda.product_ndc
ndc11	package	56104025301	derived:openfda.package_ndc
rxcui		998461	openfda.rxcui
spl id		3bba5b9f-d184-6f93-e063-6394a90ae951	id
spl set id		f186bdc1-db6c-0fab-e053-2995a90a7c58	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.

Reported adverse events (FAERS/openFDA)#

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