Medline

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: Medline
Generic name: MICONAZOLE NITRATE
Manufacturer: Medline Industries, LP
Product type: HUMAN OTC DRUG
SPL set ID: 0d997d1d-8663-201f-e063-6394a90a285e
SPL ID: 5afac954-49e5-98fb-e063-6394a90ab6aa
Version: 3
Effective date: 2026-09-08
Source export date: 2026-09-28
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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:19:52

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		Medline	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		Medline Industries, LP	openfda.manufacturer_name
ndc	package	53329-147-44	openfda.package_ndc
ndc	product	53329-147	openfda.product_ndc
ndc11	package	53329014744	derived:openfda.package_ndc
rxcui		998483	openfda.rxcui
spl id		5afac954-49e5-98fb-e063-6394a90ab6aa	id
spl set id		0d997d1d-8663-201f-e063-6394a90a285e	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 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 there is no improvement within 2 weeks for jock itch 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.