FDA.reportPublic FDA data

Ear Drops

Product NDC
0904-6627
11-digit product format
009046627
Labeler code
0904
Product ID
0904-6627_da5c2c7e-4aa9-73aa-e053-2995a90a794d
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Major Pharmaceuticals
Application
part344
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-10-10
Marketing end
0000-00-00
Substance
CARBAMIDE PEROXIDE
Active strength
7 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct0904-6627DDiscontinued by firm2026-10-16
excluded packagepackage0904-66270904-6627-35DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6627-35Ear DropsMajor1 in 1 CARTONLIQUID17
0904-6627-35Ear DropsMajor15 mL in 1 BOTTLELIQUID157

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6627-35ML - Milliliter0904-6627961d332f-97a9-4b3c-bf08-36c272f4485712017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6627EAR DROPS MAJOR (CARBAMIDE PEROXIDE 6.5%) LIQUID [MAJOR PHARMACEUTICALS]6Legacy NDC, 2 package rows20231215_ad8bce05-6be4-4f6c-9341-bce7c3aa05cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNad8bce05-6be4-4f6c-9341-bce7c3aa05cf7
702050carbamide peroxide 65 MG/ML Otic SolutionSCDad8bce05-6be4-4f6c-9341-bce7c3aa05cf7
702050carbamide peroxide 6.5 % Otic SolutionSYad8bce05-6be4-4f6c-9341-bce7c3aa05cf7
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
702050carbamide peroxide 6.5 % Otic SolutionPSNd0d69ee3-f073-2666-e053-2a95a90a72061
702050carbamide peroxide 65 MG/ML Otic SolutionSCDd0d69ee3-f073-2666-e053-2a95a90a72061
702050carbamide peroxide 6.5 % Otic SolutionSYd0d69ee3-f073-2666-e053-2a95a90a72061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6627-35009046627351 BOTTLE in 1 CARTON (0904-6627-35) > 15 mL in 1 BOTTLE1 bottle2019-10-100000-00-00NoNoCurrent