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: LEADER/ Cardinal Health 110, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: e754d590-0a92-4605-89a3-e698b8906672
SPL ID: 29bae1bd-515b-ee2a-e063-6294a90a27a4
Version: 9
Effective date: 2024-12-20
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:53:46

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		LEADER/ Cardinal Health 110, Inc.	openfda.manufacturer_name
ndc	package	70000-0323-1	openfda.package_ndc
ndc	product	70000-0323	openfda.product_ndc
ndc11	package	70000032301	derived:openfda.package_ndc
rxcui		998461	openfda.rxcui
spl id		29bae1bd-515b-ee2a-e063-6294a90a27a4	id
spl set id		e754d590-0a92-4605-89a3-e698b8906672	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.