FDA.reportPublic FDA data

ClearCanal Ear Wax Softerner Drops

Product NDC
13709-230
11-digit product format
137090230
Labeler code
13709
Product ID
13709-230_0eb0ea7e-e08e-b48e-e063-6394a90af874
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
2011-08-24
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
ClearCanal Ear Wax Softerner Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050, 1245627

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
13709-230-01ClearCanal Ear Wax Softerner Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS157
13709-230-01ClearCanal Ear Wax Softerner Drops1 in 1 BOXSOLUTION/ DROPS17
13709-230-10ClearCanal Ear Wax Softerner Drops15 mL in 1 BOTTLESOLUTION/ DROPS157
13709-230-10ClearCanal Ear Wax Softerner Drops1 in 1 KITSOLUTION/ DROPS17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13709-230-01ML - Milliliter13709-23072e8f9c5-de51-40a5-926c-229a717a61e412019-04-11
13709-230-10ML - Milliliter13709-2300f4c57e3-3242-414d-be26-311081ef8c0812022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU81CLEARCANAL NEILMED (EAR WAX REMOVAL COMPLETE KIT) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS, INC.]2
CARBAMIDE PEROXIDEACTIVE MOIETY31PZ2VAU81CLEARCANAL NEILMED (EAR WAX REMOVAL COMPLETE KIT) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS, INC.]2
AloeINACTIVE INGREDIENTV5VD430YW9CLEARCANAL NEILMED (EAR WAX REMOVAL COMPLETE KIT) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS, INC.]2
Chamomile Flower OilINACTIVE INGREDIENT60F80Z61A9CLEARCANAL NEILMED (EAR WAX REMOVAL COMPLETE KIT) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCLEARCANAL NEILMED (EAR WAX REMOVAL COMPLETE KIT) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS, INC.]2
OxyquinolineINACTIVE INGREDIENT5UTX5635HPCLEARCANAL NEILMED (EAR WAX REMOVAL COMPLETE KIT) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-230CLEARCANAL EAR WAX SOFTERNER DROPS (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20240112_0ef2be5b-cc39-48ae-b5c5-e787464dea08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN0ef2be5b-cc39-48ae-b5c5-e787464dea087
1245627clearcanal ear wax removal 6.5 % Otic SolutionPSN0ef2be5b-cc39-48ae-b5c5-e787464dea087
1245627carbamide peroxide 65 MG/ML Otic Solution [Clearcanal]SBD0ef2be5b-cc39-48ae-b5c5-e787464dea087
702050carbamide peroxide 65 MG/ML Otic SolutionSCD0ef2be5b-cc39-48ae-b5c5-e787464dea087
702050carbamide peroxide 6.5 % Otic SolutionSY0ef2be5b-cc39-48ae-b5c5-e787464dea087
1245627Clearcanal 65 MG/ML Otic SolutionSY0ef2be5b-cc39-48ae-b5c5-e787464dea087
1245627Clearcanal Ear Wax Removal Drops 6.5 % Otic SolutionSY0ef2be5b-cc39-48ae-b5c5-e787464dea087
702050carbamide peroxide 6.5 % Otic SolutionPSNac3d57a4-08d5-45f1-be84-f68eef9d13982
1245627clearcanal ear wax removal 6.5 % Otic SolutionPSNac3d57a4-08d5-45f1-be84-f68eef9d13982
1245627carbamide peroxide 65 MG/ML Otic Solution [Clearcanal]SBDac3d57a4-08d5-45f1-be84-f68eef9d13982
702050carbamide peroxide 65 MG/ML Otic SolutionSCDac3d57a4-08d5-45f1-be84-f68eef9d13982
702050carbamide peroxide 6.5 % Otic SolutionSYac3d57a4-08d5-45f1-be84-f68eef9d13982
1245627Clearcanal 65 MG/ML Otic SolutionSYac3d57a4-08d5-45f1-be84-f68eef9d13982
1245627Clearcanal Ear Wax Removal Drops 6.5 % Otic SolutionSYac3d57a4-08d5-45f1-be84-f68eef9d13982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13709-230-01137090230011 BOTTLE, DROPPER in 1 BOX (13709-230-01) / 15 mL in 1 BOTTLE, DROPPER2012-01-020000-00-00NoNoCurrent
13709-230-10137090230101 BOTTLE in 1 KIT (13709-230-10) / 15 mL in 1 BOTTLE1 bottle2012-08-240000-00-00NoNoCurrent