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_593c33ae-2b75-5130-e063-6294a90ad883
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ClearCanal Ear Wax Softerner Drops
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31PZ2VAU81Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702050Internal RxNorm lookup
1245627Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ef2be5b-cc39-48ae-b5c5-e787464dea08Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraSealDIMETHICONEBausch Health US, LLC2c8dc616-20c1-4d33-8a89-9bcdb22b35c82024-10-17WarningsExact identifier
application number: M014
fungoid tinctureMICONAZOLE NITRATEPedinol Pharmacal, Inc.250d0a66-01d1-4aba-8f24-4cb4ca529fda2024-10-17WarningsExact identifier
application number: M014
GenRx Anti-Bacterial GelALCOHOLPureTek Corporationa124e37e-1a44-212a-e053-2995a90a0af02024-10-01WarningsExact identifier
application number: M014
Hand Sanitizing with Lavender OilALCOHOLPureTek Corporationa75d25a7-1e23-717f-e053-2a95a90a6d932024-10-01WarningsExact identifier
application number: M014
Leader Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECardinal Health, Inc.0022a174-8377-44af-84a9-31adb27de1312024-08-23WarningsExact identifier
application number: M014
Leader Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDECardinal Health 110 DBA Leader36c1408b-4287-4e9f-aa17-4f05add500382024-08-12WarningsExact identifier
application number: M014
Major Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEMajor Pharmaceuticals513bf82e-a36f-49d0-ba74-c834fea4f3b52024-08-12WarningsExact identifier
application number: M014
Alcohol WipesWIPE EM ALCOHOL WIPESShaoxing Elite Bio-Tech Co., Ltd.1f373096-d3d5-af7f-e063-6394a90a3b552024-08-08WarningsExact identifier
application number: M014
Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDENuCare Pharmaceuticals,Inc.b55acec6-5a4d-08b7-e053-2995a90a0f742024-07-17WarningsExact identifier
application number: M014
BacitracinBACITRACINNuCare Pharmaceuticals,Inc.a526ae4b-baae-5d50-e053-2a95a90ae2932024-07-17WarningsExact identifier
application number: M014
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals, Inc.54241254-1d9a-346a-e054-00144ff8d46c2024-07-17WarningsExact identifier
application number: M014
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals,Inc.5786a559-a387-120d-e053-2991aa0ab6472024-07-15WarningsExact identifier
application number: M014
CVS Health Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECVS Pharmacy, Inc.42a22e06-1b66-4359-852c-7c39e1b3940a2024-06-24WarningsExact identifier
application number: M014
TolnaftateTOLNAFTATENuCare Pharmaceuticals,Inc.63665de7-8415-651f-e053-2991aa0ac2bb2024-06-06WarningsExact identifier
application number: M014
Rite Aid Earwax Removal DropsCARBAMIDE PEROXIDERite Aid1262531e-0674-cf32-e063-6294a90a0d0b2024-05-10WarningsExact identifier
application number: M014
Debrox KidsISOPROPYL ALCOHOLMedtech Products Inc.f42eee70-c4ee-44ad-85d5-a06d98ecb8b02024-05-09WarningsExact identifier
application number: M014
Rite Aid Swimmers Ear DropsISOPROPYL ALCOHOLRite Aid12875b9d-3ae8-bd0c-e063-6294a90ab4ae2024-02-29WarningsExact identifier
application number: M014
Topcare Swimmers Ear DropsISOPROPYL ALCOHOLTopco Associates LLC0fddeb43-fee0-d43c-e063-6394a90a738a2024-01-26WarningsExact identifier
application number: M014
NeilMed Clear Canal Earwax Removal kitCARBAMIDE PEROXIDENEILMED PHARMACEUTICALS INCd330552d-07b6-f01e-e053-2a95a90a7ca52024-01-11WarningsExact identifier
application number: M014
Wax Out PlusCARBAMIDE PEROXIDE DROPSNEILMED PHARMACEUTICALS INCcf64f4b8-279c-8c1d-e053-2995a90ac8532024-01-11WarningsExact identifier
application number: M014

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