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: A-S Medication Solutions
Product type: HUMAN OTC DRUG
SPL set ID: 7a0ef38a-9584-4e67-ba86-c31f86da1ed0
SPL ID: 5832c1ef-9d62-42ca-a90f-dc6748fb17cf
Version: 6
Effective date: 2023-12-11
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 05:14:08

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	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		A-S Medication Solutions	openfda.manufacturer_name
ndc	package	50090-5607-0	openfda.package_ndc
ndc	product	50090-5607	openfda.product_ndc
ndc11	package	50090560700	derived:openfda.package_ndc
rxcui		998483	openfda.rxcui
spl id		5832c1ef-9d62-42ca-a90f-dc6748fb17cf	id
spl set id		7a0ef38a-9584-4e67-ba86-c31f86da1ed0	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. When using this product, avoid contact with the eyes. Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch) Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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