NeilMed Clear Canal Earwax Removal kit

Product NDC
13709-314
11-digit product format
137090314
Labeler code
13709
Product ID
13709-314_0eb0d3b3-1a54-1c93-e063-6294a90a6d13
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide peroxide
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
NEILMED PHARMACEUTICALS INC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-25
Substance
CARBAMIDE PEROXIDE
Active strength
65 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
NeilMed Clear Canal Earwax Removal kit
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-314-01NeilMed Clear Canal Earwax Removal kit1 in 1 KITSOLUTION/ DROPS12
13709-314-01NeilMed Clear Canal Earwax Removal kit15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-314NEILMED CLEAR CANAL EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 2 package rows20240112_d330552d-07b6-f01e-e053-2a95a90a7ca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNd330552d-07b6-f01e-e053-2a95a90a7ca52
702050carbamide peroxide 65 MG/ML Otic SolutionSCDd330552d-07b6-f01e-e053-2a95a90a7ca52
702050carbamide peroxide 6.5 % Otic SolutionSYd330552d-07b6-f01e-e053-2a95a90a7ca52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13709-314-01137090314011 BOTTLE, DROPPER in 1 KIT (13709-314-01) / 15 mL in 1 BOTTLE, DROPPER2021-12-250000-00-00NoNoCurrent