FDA.reportPublic FDA data

Ear Drops

Manufacturer
CVS Pharmacy | Pharma Nobis, LLC
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:05:10

Label at a glance#

ProductEar Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Citric Acid

Flavor

Glycerin

Propylene Glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified Water

OTC - PURPOSE SECTION

Earwax removal aid.

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

For External Use Only.

Ask a doctor before use if you have:

Ear drainage or discharge

Ear pain, irritation, or rash in the ear

Recently had ear surgery

Dizziness

An injury or perforation (hole) of the eadrum

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5%

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSWax.jpgCVSWax.jpgcartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN5
702050carbamide peroxide 65 MG/ML Otic SolutionSCD5
702050carbamide peroxide 6.5 % Otic SolutionSY5

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
69842-097-45Ear Drops15 mL in 1 BOTTLE, DROPPERLIQUID155
69842-097-45Ear Drops1 in 1 CARTONLIQUID15
69842-097-90Ear Drops1 in 1 CARTONLIQUID15
69842-097-90Ear Drops15 mL in 1 CONTAINERLIQUID155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-097EAR DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [CVS PHARMACY]5Current NDC, Legacy NDC, 4 package rows20231221_8a872991-01af-5fd0-e053-2995a90ac7f4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-09769842-097-90, 69842-097-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM STANNATENJ7C1V83KGIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
WATER059QF0KO0RIACT

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
Ear DropsCARBAMIDE PEROXIDE 6.5%CVS Pharmacy8a872991-01af-5fd0-e053-2995a90ac7f42023-12-20WarningsExact identifier
ndc (package): 69842-097-90
ndc (package): 69842-097-45
ndc (product): 69842-097
ndc11 (package): 69842009790
ndc11 (package): 69842009745
spl id: 0cf923ef-4234-8454-e063-6294a90afe9c
spl set id: 8a872991-01af-5fd0-e053-2995a90ac7f4

Reported adverse events (FAERS/openFDA)#

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