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: MICONAZOLE NITRATE
Manufacturer: AvPAK
Product type: HUMAN OTC DRUG
SPL set ID: eaf016f6-b631-af00-e053-2a95a90adc7b
SPL ID: 47fa5320-5565-5626-e063-6394a90a4396
Version: 7
Effective date: 2026-01-09
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 05:55:04

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		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		AvPAK	openfda.manufacturer_name
ndc	package	50268-503-29	openfda.package_ndc
ndc	product	50268-503	openfda.product_ndc
ndc11	package	50268050329	derived:openfda.package_ndc
rxcui		998525	openfda.rxcui
spl id		47fa5320-5565-5626-e063-6394a90a4396	id
spl set id		eaf016f6-b631-af00-e053-2a95a90adc7b	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 DO NOT USE ON CHILDREN UNDER TWO YEARS OF AGE EXCEPT UNDER THE ADVICE AND SUPERVISION OF A DOCTOR. FOR EXTERNAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact Poison Control Center immediately. Avoid contact with eyes. If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor or pharmacist. Do not use if you are diabetic or have circulatory, renal, or hepatic problems, consult a doctor or pharmacist before using.

Reported adverse events (FAERS/openFDA)#

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