Ear Drops

Product NDC
0904-6627
11-digit product format
009046627
Labeler code
0904
Product ID
0904-6627_3afc65d5-4dbc-d1c5-e063-6294a90a41d6
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Major Pharmaceuticals
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-10
Marketing end
2026-09-30
Substance
CARBAMIDE PEROXIDE
Active strength
6.5 g/100mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ear Drops
Brand name suffix
Major

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

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]6Current NDC, Legacy 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 bottle2019-10-102026-09-30NoNoCurrent