FDA.reportPublic FDA data

DoloEar

Manufacturer
Pharmadel LLC
Effective date
2026-03-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:51:38

Label at a glance#

ProductDoloEar
Active ingredientCARBAMIDE PEROXIDE
Label structure9 sections

Indications and uses

For occasional use as an aid to loosen and remove excessive earwax.

Dosage and administration

FOR USE IN THE EAR ONLY adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm wat...

Label contents#

Full prescribing information#

Active Ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

.

OTC - PURPOSE SECTION

Active ingredient

Purpose
Carbamide peroxide 6.5%...............Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

For occasional use as an aid to loosen and remove excessive earwax.

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and ask your doctor if

OTC - STOP USE SECTION

  • you need to use for more than 4 days
  • excessive earwax remains after use of this product

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • FOR USE IN THE EAR ONLY
  • adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
  • children under 12 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • Store in a cool dry place
  • do not use if clear seal over dropper is torn, broken, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, water

Questions or comments?

OTC - QUESTIONS SECTION

+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Dist. by/ por:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC

New Castle, DE 19720

+1-866-359-3478

www.pharmadel.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP DOLOEARPDP DOLOEAR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN3
702050carbamide peroxide 65 MG/ML Otic SolutionSCD3
702050carbamide peroxide 6.5 % Otic SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-506-01DoloEar1 in 1 CARTONLIQUID13
55758-506-01DoloEar15 mL in 1 BOTTLE, DROPPERLIQUID153

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-50655758-506-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-05-29monthly-update2026-06-03 17:45:25

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoloEarCARBAMIDE PEROXIDEPharmadel LLC352df636-0469-c33e-e063-6294a90a22242026-03-26WarningsExact identifier
ndc (package): 55758-506-01
ndc (product): 55758-506
ndc11 (package): 55758050601
spl id: 4df01db0-dba9-6561-e063-6294a90a6d15
spl set id: 352df636-0469-c33e-e063-6294a90a2224

Reported adverse events (FAERS/openFDA)#

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