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: Preferred Pharmaceuticals Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 14d2a661-a490-41ca-b84f-f2be3bc271b4
SPL ID: 14d2a661-a490-41ca-b84f-f2be3bc271b4
Version: 1
Effective date: 2025-03-24
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:56:26

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 2% Cream ANTIFUNGAL	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		Preferred Pharmaceuticals Inc.	openfda.manufacturer_name
ndc	package	68788-8845-3	openfda.package_ndc
ndc	product	68788-8845	openfda.product_ndc
ndc11	package	68788884503	derived:openfda.package_ndc
rxcui		998483	openfda.rxcui
spl id		14d2a661-a490-41ca-b84f-f2be3bc271b4	id
spl set id		14d2a661-a490-41ca-b84f-f2be3bc271b4	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.