FDA.reportPublic FDA data

Good Neighbor Pharmacy Ear System

Manufacturer
AmerisourceBergen Drug Corporation | Product Quest Mfg, LLC
Effective date
2015-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:08

Label at a glance#

ProductGood Neighbor Pharmacy Ear System
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Indications and uses

For occasional use as an aid to soften, loosen, and remove excessive ear wax.

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 ear. Use twice daily for up to four 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#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                            Purpose

Carbamide Peroxide 6.5%..............................Softens & removes wax

Purpose

OTC - PURPOSE SECTION

Softens & removes wax

Uses

INDICATIONS & USAGE SECTION

For occasional use as an aid to soften, loosen, and remove

excessive ear wax.

Warnings

WARNINGS SECTION

Do Not Use

OTC - DO NOT USE SECTION

•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 eardrum or after

ear surgery, unless directed by a doctor.

•for more than four consecutive days.

When using this product

OTC - WHEN USING SECTION

•avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• excessive ear wax remains after

use of this product for four consecutive days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or

contact a Poison Control Center right away. If accidental contact

with eyes occurs, flush eyes with water and consult a doctor.

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 ear. Use twice

daily for up to four 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

SPL UNCLASSIFIED SECTION

• Protect from heat and direct sunlight.

• Keep cap on bottle when not in use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Oxyquinoline.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ear system.jpgear system.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN1
702050carbamide peroxide 65 MG/ML Otic SolutionSCD1
702050carbamide peroxide 6.5 % Otic SolutionSY1

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24385-503-052020-01-31C16284748780-19d75b9cf-ef15-f424-e053-dadaa90a57ceGood Neighbor Pharmacy Ear System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-503-05Good Neighbor Pharmacy Ear System15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-503GOOD NEIGHBOR PHARMACY EAR SYSTEM (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [AMERISOURCEBERGEN DRUG CORPORATION]1Legacy NDC, 1 package rows20150723_392378b5-c5c1-41e0-aac1-800dfeee8142.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-503-05ML - Milliliter24385-50324bf5809-b9ec-43c6-80a2-bdda93c871db12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU811
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9V1
OXYQUINOLINEINACTIVE INGREDIENT5UTX5635HP1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24385-50324385-503-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
OXYQUINOLINE5UTX5635HPIACT

Source Document#

Source XML

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
232937b5-93d7-4d74-b15e-23fdb2a39590392378b5-c5c1-41e0-aac1-800dfeee81422015-07-22WarningsExact identifier
spl id: 232937b5-93d7-4d74-b15e-23fdb2a39590
spl set id: 392378b5-c5c1-41e0-aac1-800dfeee8142

Reported adverse events (FAERS/openFDA)#

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