FDA.reportPublic FDA data

CareOne Earwax Removal Drops

Product NDC
72476-838
11-digit product format
724760838
Labeler code
72476
Product ID
72476-838_a0a6c2e9-d6f4-4527-e053-2995a90a51a1
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Retail Business Services, LLC
Application
part344
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-01-01
Marketing end
0000-00-00
Substance
CARBAMIDE PEROXIDE
Active strength
65 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72476-838DDiscontinued by firm2026-11-10
excluded packagepackage72476-83872476-838-34DDiscontinued by firm2026-11-10

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-838-34CareOne Earwax Removal Drops15 mL in 1 BOTTLESOLUTION/ DROPS152
72476-838-34CareOne Earwax Removal Drops1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-838CAREONE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [RETAIL BUSINESS SERVICES, LLC]2Legacy NDC, 2 package rows20231219_13a161c6-bc06-4315-9cc9-fe49d046cd6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN13a161c6-bc06-4315-9cc9-fe49d046cd6f2
702050carbamide peroxide 65 MG/ML Otic SolutionSCD13a161c6-bc06-4315-9cc9-fe49d046cd6f2
702050carbamide peroxide 6.5 % Otic SolutionSY13a161c6-bc06-4315-9cc9-fe49d046cd6f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72476-838-34724760838341 BOTTLE in 1 BOX (72476-838-34) > 15 mL in 1 BOTTLE1 bottle2020-01-010000-00-00NoNoCurrent