Ear Drops

Product NDC
50090-5273
11-digit product format
500905273
Labeler code
50090
Product ID
50090-5273_bac0c4d3-f01c-4ade-a739-51480e272328
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
A-S Medication Solutions
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-10
Substance
CARBAMIDE PEROXIDE
Active strength
6.5 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Ear Drops
Brand name suffix
Major
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE6.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31PZ2VAU81Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702050Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb7df1cc-50db-479a-bc1c-dfd7004dd35bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5273-02024-01-08C16284748780-1f386c64a-18ea-0266-e053-dadaa90a7c1aEar Drops Major
50090-5273-02023-01-30C16284748780-1f386c64a-18ea-0266-e053-dadaa90a7c1aEar Drops Major

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5273-0Ear DropsMajor15 mL in 1 BOTTLELIQUID156
50090-5273-0Ear DropsMajor1 in 1 CARTONLIQUID16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5273-0ML - Milliliter50090-527353def603-5221-484a-9ef1-47c7a534288212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5273EAR DROPS MAJOR (CARBAMIDE PEROXIDE 6.5%) LIQUID [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240109_eb7df1cc-50db-479a-bc1c-dfd7004dd35b.zip

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 6 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SuavEar Earwax Removal AidEARWAX REMOVAL AIDNEILMED PHARMACEUTICALS INCc067f1a4-1f67-3f4d-e053-2a95a90a60952024-01-11WarningsExact identifier
application number: M014
Ear Drops MajorCARBAMIDE PEROXIDE 6.5%A-S Medication Solutionseb7df1cc-50db-479a-bc1c-dfd7004dd35b2024-01-08WarningsExact identifier
application number: M014
ndc (product): 50090-5273
Wax B Gone Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%SIGMAR, LLC3339cac0-8f32-4f71-bef3-dd1524c4b2442024-01-08WarningsExact identifier
application number: M014
Ear Drops for SwimmersISOPROPYL ALCOHOLPharma Nobis, LLCe42fd693-24ab-0fc0-e053-2995a90ab9542023-12-26WarningsExact identifier
application number: M014
LEADER Ear Drops for SwimmersLEADER EAR DROPS FOR SWIMMERSCardinal Health, 110 dba Leader874857eb-2a9d-6ef7-e053-2995a90af1562023-12-22WarningsExact identifier
application number: M014
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Pharma Nobis, LLCe21e114c-99b6-861c-e053-2995a90aeac12023-12-22WarningsExact identifier
application number: M014
Quality Choice Instant Ear DryISOPROPYL ALCOHOLChain Drug Manufacturing Association9d3c681b-a941-6ddb-e053-2a95a90ad3bf2023-12-20WarningsExact identifier
application number: M014
Premiere Value Ear Drops for SwimmersISOPROPYL ALCOHOLPharmacy Value Alliance; LLC9d606fe6-ae57-724f-e053-2a95a90abffe2023-12-20WarningsExact identifier
application number: M014
CVS Ear Drops for SwimmersISOPROPYL ALCOHOLCVS Pharmacycc4614ee-5d6e-4a07-9826-aff12cc35abd2023-12-20WarningsExact identifier
application number: M014
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Randob Labs, Ltd.a9904b63-27a4-205c-e053-2995a90af7622023-12-19WarningsExact identifier
application number: M014
DDM Ear Drops for SwimmersISOPROPYL ALCOHOLDiscount Drug Mart5d565cbc-874b-41dc-e053-2991aa0a67872023-12-19WarningsExact identifier
application number: M014
TopCare Swimmers Ear DropsISOPROPYL ALCOHOLTOPCO ASSOCIATES9dccbc25-d954-f917-e053-2a95a90a0eff2023-12-18WarningsExact identifier
application number: M014
HEB Water Drying AidISOPROPYL ALCOHOLH E B5d5741f8-64fd-0a9a-e053-2991aa0a0b5e2023-12-18WarningsExact identifier
application number: M014
Best Choice Earwax Removal KitCARBAMIDE PEROXIDEValu Merchandisers, Co.f943ac0e-8171-446d-8c6c-69612b4826432023-12-15WarningsExact identifier
application number: M014
Quality Choice Earwax Removal KitCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.ba8d71b5-7f1f-44a5-ac5b-1f7ceeb028752023-12-15WarningsExact identifier
application number: M014
DISCOUNT drug mart FOOD FAIR earwax removal kitCARBAMIDE PEROXIDEDiscount Drug Mart83fdf4d6-3cdf-429d-b53d-80775a35d0c92023-12-15WarningsExact identifier
application number: M014
Discount Drug Mart Earwax Removal DropsCARBAMIDE PEROXIDEDiscount Drug Marte30c943e-bba5-4520-8f83-16bfa29ee1cf2023-12-15WarningsExact identifier
application number: M014
HUMCO Ear Drops for SwimmersISOPROPYL ALCOHOLHumco Holding Group, Inc.6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b22023-12-15WarningsExact identifier
application number: M014
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Humco Holding Group, Inca8c052d8-fb9c-09f2-e053-2a95a90a37af2023-12-15WarningsExact identifier
application number: M014
EAR DRYING AGENTISOPROPYL ALCOHOL 94.998% GLYCERIN 5%Rite Aid9b4299af-c1a2-43e6-90d4-25f4c89d1bef2023-12-15WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNeb7df1cc-50db-479a-bc1c-dfd7004dd35b6
702050carbamide peroxide 65 MG/ML Otic SolutionSCDeb7df1cc-50db-479a-bc1c-dfd7004dd35b6
702050carbamide peroxide 6.5 % Otic SolutionSYeb7df1cc-50db-479a-bc1c-dfd7004dd35b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5273-0500905273001 BOTTLE in 1 CARTON (50090-5273-0) / 15 mL in 1 BOTTLE1 bottle2020-10-200000-00-00NoNoCurrent