MICONAZOLE Nitrate 2% Cream 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: MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Generic name: MICONAZOLE NITRATE
Manufacturer: Trifecta Pharmaceuticals Usa Llc
Product type: HUMAN OTC DRUG
SPL set ID: 80217dbb-a0f0-414a-8d22-a9a346b017aa
SPL ID: 4e55e0bf-9e9d-d877-e063-6294a90a9d59
Version: 14
Effective date: 2026-03-31
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:35:50

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 · 21 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		Trifecta Pharmaceuticals Usa Llc	openfda.manufacturer_name
ndc	package	69396-014-33	openfda.package_ndc
ndc	package	69396-014-05	openfda.package_ndc
ndc	package	69396-014-20	openfda.package_ndc
ndc	package	69396-014-44	openfda.package_ndc
ndc	package	69396-014-66	openfda.package_ndc
ndc	package	69396-014-04	openfda.package_ndc
ndc	product	69396-014	openfda.product_ndc
ndc11	package	69396001466	derived:openfda.package_ndc
ndc11	package	69396001444	derived:openfda.package_ndc
ndc11	package	69396001404	derived:openfda.package_ndc
ndc11	package	69396001405	derived:openfda.package_ndc
ndc11	package	69396001420	derived:openfda.package_ndc
ndc11	package	69396001433	derived:openfda.package_ndc
rxcui		998483	openfda.rxcui
spl id		4e55e0bf-9e9d-d877-e063-6294a90a9d59	id
spl set id		80217dbb-a0f0-414a-8d22-a9a346b017aa	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 if the safety-sealed tube is punctured or damaged. Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes. Stop use and ask a healthcare professional if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

Reported adverse events (FAERS/openFDA)#

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