Triple 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: Triple Antifungal
Generic name: MICONAZOLE NITRATE
Manufacturer: Advantice Health, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 9a47fb1b-a41f-4c8a-8e43-7332853c308e
SPL ID: 4d63f2a2-f113-d739-e063-6394a90a2d27
Version: 4
Effective date: 2026-03-19
Source export date: 2026-10-30
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/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:36:54

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		Triple Antifungal	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		Advantice Health, LLC	openfda.manufacturer_name
ndc	package	16864-040-02	openfda.package_ndc
ndc	product	16864-040	openfda.product_ndc
ndc11	package	16864004002	derived:openfda.package_ndc
rxcui		998460	openfda.rxcui
rxcui		998442	openfda.rxcui
spl id		4d63f2a2-f113-d739-e063-6394a90a2d27	id
spl set id		9a47fb1b-a41f-4c8a-8e43-7332853c308e	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 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 Do not use on children under 2 years of age unless directed by a doctor. 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.