RoyceDerm Tinea Antifungal Cream

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: RoyceDerm Tinea Antifungal Cream
Generic name: MICONAZOLE NITRATE 2%
Manufacturer: RoyceDerm LLC
Product type: HUMAN OTC DRUG
SPL set ID: 40089a7d-c893-4e90-e063-6294a90aa6f9
SPL ID: 51214ad2-0c70-a6d2-e063-6394a90a9649
Version: 2
Effective date: 2026-05-06
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:55:57

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		RoyceDerm Tinea Antifungal Cream	openfda.brand_name
generic name		MICONAZOLE NITRATE 2%	openfda.generic_name
manufacturer name		RoyceDerm LLC	openfda.manufacturer_name
ndc	package	85424-011-01	openfda.package_ndc
ndc	package	85424-011-02	openfda.package_ndc
ndc	product	85424-011	openfda.product_ndc
ndc11	package	85424001101	derived:openfda.package_ndc
ndc11	package	85424001102	derived:openfda.package_ndc
rxcui		998483	openfda.rxcui
spl id		51214ad2-0c70-a6d2-e063-6394a90a9649	id
spl set id		40089a7d-c893-4e90-e063-6294a90aa6f9	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

For external use only Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm. 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.