GeriGentle 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: GeriGentle Miconazole nitrate
Generic name: ANTIFUNGAL
Manufacturer: GERI-GENTLE CORPORATION
Product type: HUMAN OTC DRUG
SPL set ID: 0ae03b4a-06c8-ddf9-e063-6294a90ad105
SPL ID: 6ff1ce91-f486-4701-ae08-909da151b402
Version: 5
Effective date: 2026-06-16
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 02:56:08

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		GeriGentle Miconazole nitrate	openfda.brand_name
generic name		ANTIFUNGAL	openfda.generic_name
manufacturer name		GERI-GENTLE CORPORATION	openfda.manufacturer_name
ndc	package	69771-165-03	openfda.package_ndc
ndc	product	69771-165	openfda.product_ndc
ndc11	package	69771016503	derived:openfda.package_ndc
rxcui		998461	openfda.rxcui
spl id		6ff1ce91-f486-4701-ae08-909da151b402	id
spl set id		0ae03b4a-06c8-ddf9-e063-6294a90ad105	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 ■For diaper rash When using this product avoid contact with the eyes Stop use and ask a doctor if ■Irritation occurs ■There is no improvement within 2 weeks when used for the treatment of jock itch ■There is no improvement within 4 weeks when used for athlete's foot or ringworm 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.