AZOLEN

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: AZOLEN
Generic name: MICONAZOLE NITRATE
Manufacturer: STRATUS PHARMACEUTICALS INC
Product type: HUMAN OTC DRUG
SPL set ID: 3264bd0a-c628-404b-8c09-8586682d054e
SPL ID: 85b974c1-bef2-4320-93a4-0fcf7774c55c
Version: 2
Effective date: 2024-10-31
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:31:12

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		AZOLEN	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		STRATUS PHARMACEUTICALS INC	openfda.manufacturer_name
ndc	package	58980-819-60	openfda.package_ndc
ndc	product	58980-819	openfda.product_ndc
ndc11	package	58980081960	derived:openfda.package_ndc
spl id		85b974c1-bef2-4320-93a4-0fcf7774c55c	id
spl set id		3264bd0a-c628-404b-8c09-8586682d054e	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 for diaper rash When using this product avoid contact with eyes Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks (for jock itch) there is no improvement within 4 weeks (for athlete's foot and ringworm) Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately

Reported adverse events (FAERS/openFDA)#

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