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 POWDER SPRAY
Manufacturer: Premier Brands of America Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 38ccf19c-2290-ad99-e063-6394a90a5469
SPL ID: 42f401f0-e0c2-bad0-e063-6294a90ad799
Version: 2
Effective date: 2025-11-06
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:57:19

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 POWDER SPRAY	openfda.generic_name
manufacturer name		Premier Brands of America Inc.	openfda.manufacturer_name
ndc	package	56104-907-01	openfda.package_ndc
ndc	product	56104-907	openfda.product_ndc
ndc11	package	56104090701	derived:openfda.package_ndc
rxcui		998428	openfda.rxcui
spl id		42f401f0-e0c2-bad0-e063-6294a90ad799	id
spl set id		38ccf19c-2290-ad99-e063-6394a90a5469	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. Intentional misuse by deliberately concentrating and inhaling contents can 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 irritation occurs no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch 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 Central right away.

Reported adverse events (FAERS/openFDA)#

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