CAREALL 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: CAREALL Miconazole Nitrate
Generic name: MICONAZOLE NITRATE
Manufacturer: New World Imports, Inc
Product type: HUMAN OTC DRUG
SPL set ID: bed775be-8bcb-44c2-9b9f-8bb25b4b2453
SPL ID: 44ebdc80-6f2e-836c-e063-6394a90aeba7
Version: 7
Effective date: 2025-12-01
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:14:49

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		CAREALL Miconazole Nitrate	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		New World Imports, Inc	openfda.manufacturer_name
ndc	package	51824-078-01	openfda.package_ndc
ndc	product	51824-078	openfda.product_ndc
ndc11	package	51824007801	derived:openfda.package_ndc
rxcui		998483	openfda.rxcui
spl id		44ebdc80-6f2e-836c-e063-6394a90aeba7	id
spl set id		bed775be-8bcb-44c2-9b9f-8bb25b4b2453	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. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoide contact with eyes Stop use and ask doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Reported adverse events (FAERS/openFDA)#

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