FifthPulse Miconazole Nitrate Antifungal

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: FifthPulse Miconazole Nitrate Antifungal
Generic name: MICONAZOLE NITRATE
Manufacturer: WeCare Products LLC
Product type: HUMAN OTC DRUG
SPL set ID: b70238eb-afcb-4e09-976f-973df249241c
SPL ID: 4e7d2ee6-0c87-7391-e063-6394a90a4ee8
Version: 1
Effective date: 2026-04-02
Source export date: 2026-09-28
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:39:33

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		FifthPulse Miconazole Nitrate Antifungal	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		WeCare Products LLC	openfda.manufacturer_name
ndc	package	87525-004-01	openfda.package_ndc
ndc	package	87525-004-02	openfda.package_ndc
ndc	product	87525-004	openfda.product_ndc
ndc11	package	87525000401	derived:openfda.package_ndc
ndc11	package	87525000402	derived:openfda.package_ndc
spl id		4e7d2ee6-0c87-7391-e063-6394a90a4ee8	id
spl set id		b70238eb-afcb-4e09-976f-973df249241c	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 if the safety-sealed tube is punctured or damaged. Do not use on children 2 years of age unless directed by a doctor. When using this product avoid contact with eyes. Stop use and ask a doctor if Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch). Irritation occurs, or if 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 immediately.

Reported adverse events (FAERS/openFDA)#

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