Anti-fungal Powder 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 Powder Miconazole Nitrate
Generic name: MICONAZOLE NITRATE
Manufacturer: Premier Brands of America Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 052d8d02-2381-1e3a-e063-6394a90aa07e
SPL ID: 42537026-f1f3-422f-e063-6394a90a07e9
Version: 4
Effective date: 2025-10-29
Source export date: 2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:54:32

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 Powder Miconazole Nitrate	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		Premier Brands of America Inc.	openfda.manufacturer_name
ndc	package	56104-500-00	openfda.package_ndc
ndc	product	56104-500	openfda.product_ndc
ndc11	package	56104050000	derived:openfda.package_ndc
rxcui		998461	openfda.rxcui
spl id		42537026-f1f3-422f-e063-6394a90a07e9	id
spl set id		052d8d02-2381-1e3a-e063-6394a90aa07e	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 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.