DoloEar

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: DoloEar
Generic name: CARBAMIDE PEROXIDE
Manufacturer: Pharmadel LLC
Product type: HUMAN OTC DRUG
SPL set ID: 352df636-0469-c33e-e063-6294a90a2224
SPL ID: 4df01db0-dba9-6561-e063-6294a90a6d15
Version: 3
Effective date: 2026-03-26
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:35:47

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M014	openfda.application_number
brand name		DoloEar	openfda.brand_name
generic name		CARBAMIDE PEROXIDE	openfda.generic_name
manufacturer name		Pharmadel LLC	openfda.manufacturer_name
ndc	package	55758-506-01	openfda.package_ndc
ndc	product	55758-506	openfda.product_ndc
ndc11	package	55758050601	derived:openfda.package_ndc
rxcui		702050	openfda.rxcui
spl id		4df01db0-dba9-6561-e063-6294a90a6d15	id
spl set id		352df636-0469-c33e-e063-6294a90a2224	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

Warnings Ask a doctor before use if you have ear drainage or discharge ear pain irritation or rash in the ear dizziness an injury or perforation (hole) of the ear drum recently had ear surgery When using this product avoid contact with the eyes. Stop use and ask your doctor if you need to use for more than 4 days excessive earwax remains after use of this product Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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