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: 9c2574f3-3be4-405a-9c87-943dc6ef8777
SPL ID: 0892f504-c8a8-4aff-9901-223635b876c2
Version: 4
Effective date: 2025-10-30
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:25:23

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		Azolen	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		Stratus Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	58980-818-10	openfda.package_ndc
ndc	product	58980-818	openfda.product_ndc
ndc11	package	58980081810	derived:openfda.package_ndc
rxcui		998525	openfda.rxcui
spl id		0892f504-c8a8-4aff-9901-223635b876c2	id
spl set id		9c2574f3-3be4-405a-9c87-943dc6ef8777	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 except under supervision of doctor. Avoid contact with eyes. If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor. Keep out of the 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.