Ear Drops (Carbamide Peroxide 6.5%)

Product NDC
68071-2568
11-digit product format
680712568
Labeler code
68071
Product ID
68071-2568_d0d69ee3-f074-2666-e053-2a95a90a7206
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide 6.5%
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
NuCare Pharmaceuticals,Inc.
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2568-52023-01-30C16284748780-1f386c649-ef3e-0266-e053-dadaa90a7c1aEar Drops Major

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2568-5Ear Drops (Carbamide Peroxide 6.5%)Major1 in 1 CARTONLIQUID11
68071-2568-5Ear Drops (Carbamide Peroxide 6.5%)Major15 mL in 1 BOTTLELIQUID151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2568EAR DROPS (CARBAMIDE PEROXIDE 6.5%) MAJOR (CARBAMIDE PEROXIDE 6.5%) LIQUID [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20211116_d0d69ee3-f073-2666-e053-2a95a90a7206.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
68071-2568-5680712568051 BOTTLE in 1 CARTON (68071-2568-5) > 15 mL in 1 BOTTLE1 bottle2021-11-150000-00-00NoNoCurrent