Claravie

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: Claravie
Generic name: MICONAZOLE NITRATE
Manufacturer: Gentell LLC
Product type: HUMAN OTC DRUG
SPL set ID: 596d590b-e7ff-4be3-e063-6294a90a871d
SPL ID: 596d590b-e800-4be3-e063-6294a90a871d
Version: 1
Effective date: 2026-08-20
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:18:44

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		Claravie	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		Gentell LLC	openfda.manufacturer_name
ndc	package	61554-305-11	openfda.package_ndc
ndc	package	61554-305-21	openfda.package_ndc
ndc	product	61554-305	openfda.product_ndc
ndc11	package	61554030511	derived:openfda.package_ndc
ndc11	package	61554030521	derived:openfda.package_ndc
rxcui		998483	openfda.rxcui
spl id		596d590b-e800-4be3-e063-6294a90a871d	id
spl set id		596d590b-e7ff-4be3-e063-6294a90a871d	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 bv a doctor When using this product avoid contact with eves Stop use and ask a doctor if Irritation occurs There is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Reported adverse events (FAERS/openFDA)#

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