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: MICONAZOLE NITRATE
Manufacturer: ALLIED TRADE LINK LLC
Product type: HUMAN OTC DRUG
SPL set ID: 25520dba-0159-2a3f-e063-6294a90a4c33
SPL ID: 26bc78a5-3755-5f69-e063-6394a90a11a8
Version: 2
Effective date: 2024-11-12
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:14:17

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		MICONAZOLE NITRATE	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		ALLIED TRADE LINK LLC	openfda.manufacturer_name
ndc	package	84387-003-01	openfda.package_ndc
ndc	product	84387-003	openfda.product_ndc
ndc11	package	84387000301	derived:openfda.package_ndc
spl id		26bc78a5-3755-5f69-e063-6394a90a11a8	id
spl set id		25520dba-0159-2a3f-e063-6294a90a4c33	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 · 2 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 the eyes Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no improvement within 4 weeks when used for athlete's foot and ringworm Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings and cautions

WARNINGS FOR EXTERNAL USE ONLY Miconazole Nitrate 2% 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 the eyes Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no improvement within 4 weeks when used for athlete's foot and ringworm Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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