Healthy Ears

Product NDC
69469-650
11-digit product format
694690650
Labeler code
69469
Product ID
69469-650_38429bd1-d2d5-0b3c-e063-6394a90adc71
Type
HUMAN OTC DRUG
Nonproprietary name
Carbide Peroxide
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Vitamex USA, Corp
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-28
Substance
CARBAMIDE PEROXIDE
Active strength
6.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Healthy Ears
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE6.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69469-650-05Healthy Ears14.7 mL in 1 BOTTLE, DROPPERSOLUTION14.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69469-650HEALTHY EARS (CARBIDE PEROXIDE) SOLUTION [VITAMIN USA, CORP]1Current NDC, 1 package rows20241101_25953441-cd8e-5038-e063-6294a90ae401.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN25953441-cd8e-5038-e063-6294a90ae4012
702050carbamide peroxide 65 MG/ML Otic SolutionSCD25953441-cd8e-5038-e063-6294a90ae4012
702050carbamide peroxide 6.5 % Otic SolutionSY25953441-cd8e-5038-e063-6294a90ae4012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69469-650-056946906500514.7 mL in 1 BOTTLE, DROPPER (69469-650-05) 14.7 ml2024-10-28NoNoHistorical