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: Miconazole Nitrate
Generic name: ANTIFUNGAL LIQUID CONTINUOUS SPRAY
Manufacturer: Chain Drug Consortium, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 7f6912a6-a576-4138-bd78-a075a7d24036
SPL ID: 38915860-95e4-69f8-e063-6394a90aa107
Version: 11
Effective date: 2025-06-27
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:10:01

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		Miconazole Nitrate	openfda.brand_name
generic name		ANTIFUNGAL LIQUID CONTINUOUS SPRAY	openfda.generic_name
manufacturer name		Chain Drug Consortium, LLC	openfda.manufacturer_name
ndc	package	68016-516-00	openfda.package_ndc
ndc	product	68016-516	openfda.product_ndc
ndc11	package	68016051600	derived:openfda.package_ndc
rxcui		998533	openfda.rxcui
spl id		38915860-95e4-69f8-e063-6394a90aa107	id
spl set id		7f6912a6-a576-4138-bd78-a075a7d24036	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. Extremely flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate, contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal. When using this product avoid contact with the eyes or mouth use only as directed Stop use and ask a doctor if no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch irritation occurs 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.