Freskaro Earwax Removal Aid

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: Freskaro Earwax Removal Aid
Generic name: CARBAMIDE PEROXIDE 6.50% KIT
Manufacturer: Pharma Nobis, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 4f5967ee-bc05-341c-e063-6394a90a35c6
SPL ID: 4f86b363-aff6-1bfb-e063-6394a90a317f
Version: 2
Effective date: 2026-04-15
Source export date: 2026-10-27
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:14:48

Harmonized routes table
Harmonized routes
AURICULAR (OTIC)

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M014	openfda.application_number
brand name		Freskaro Earwax Removal Aid	openfda.brand_name
generic name		CARBAMIDE PEROXIDE 6.50% KIT	openfda.generic_name
manufacturer name		Pharma Nobis, LLC	openfda.manufacturer_name
ndc	package	82645-097-90	openfda.package_ndc
ndc	package	82645-097-45	openfda.package_ndc
ndc	product	82645-097	openfda.product_ndc
ndc11	package	82645009745	derived:openfda.package_ndc
ndc11	package	82645009790	derived:openfda.package_ndc
rxcui		702050	openfda.rxcui
spl id		4f86b363-aff6-1bfb-e063-6394a90a317f	id
spl set id		4f5967ee-bc05-341c-e063-6394a90a35c6	set_id
unii		31PZ2VAU81	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

Do not use if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor if you have an injury or perforation (hole) of the ear or after ear surgery, unless directed by a doctor for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor.

Reported adverse events (FAERS/openFDA)#

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