FDA.reportPublic FDA data

Ear Drops

Product NDC
0904-6627
Requested package NDC
0904-6627-35
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0904-66270904-6627-35DDiscontinued by firm2026-10-05

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

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 Drops MajorCARBAMIDE PEROXIDE 6.5%Major Pharmaceuticalsad8bce05-6be4-4f6c-9341-bce7c3aa05cf2025-07-28WarningsExact identifier
ndc (package): 0904-6627-35
ndc (product): 0904-6627
ndc11 (package): 00904662735

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