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: JOCK ITCH SPRAY
Manufacturer: Harris Teeter, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 636b0d6f-4e36-4c96-9e71-7bfdebb7f3cb
SPL ID: 42652d2a-55bc-ff58-e063-6294a90a8136
Version: 7
Effective date: 2025-10-30
Source export date: 2026-11-06
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/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 08:09:48

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 · 10 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		JOCK ITCH SPRAY	openfda.generic_name
manufacturer name		Harris Teeter, LLC	openfda.manufacturer_name
ndc	package	69256-038-46	openfda.package_ndc
ndc	product	69256-038	openfda.product_ndc
ndc11	package	69256003846	derived:openfda.package_ndc
spl id		42652d2a-55bc-ff58-e063-6294a90a8136	id
spl set id		636b0d6f-4e36-4c96-9e71-7bfdebb7f3cb	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. 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. When using this product do not get into eyes or mouth use only as directed. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal. Stop use and ask a doctor if irritation occurs no improvement within 2 weeks for jock itch Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age. Do not use for diaper rash. Do not use on children under 2 years of age unless directed by a doctor.

Reported adverse events (FAERS/openFDA)#

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