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#

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 6 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SuavEar Earwax Removal AidEARWAX REMOVAL AIDNEILMED PHARMACEUTICALS INCc067f1a4-1f67-3f4d-e053-2a95a90a60952024-01-11WarningsExact identifier
application number: M014
Ear Drops MajorCARBAMIDE PEROXIDE 6.5%A-S Medication Solutionseb7df1cc-50db-479a-bc1c-dfd7004dd35b2024-01-08WarningsExact identifier
application number: M014
Wax B Gone Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%SIGMAR, LLC3339cac0-8f32-4f71-bef3-dd1524c4b2442024-01-08WarningsExact identifier
application number: M014
Ear Drops for SwimmersISOPROPYL ALCOHOLPharma Nobis, LLCe42fd693-24ab-0fc0-e053-2995a90ab9542023-12-26WarningsExact identifier
application number: M014
LEADER Ear Drops for SwimmersLEADER EAR DROPS FOR SWIMMERSCardinal Health, 110 dba Leader874857eb-2a9d-6ef7-e053-2995a90af1562023-12-22WarningsExact identifier
application number: M014
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Pharma Nobis, LLCe21e114c-99b6-861c-e053-2995a90aeac12023-12-22WarningsExact identifier
application number: M014
Quality Choice Instant Ear DryISOPROPYL ALCOHOLChain Drug Manufacturing Association9d3c681b-a941-6ddb-e053-2a95a90ad3bf2023-12-20WarningsExact identifier
application number: M014
Premiere Value Ear Drops for SwimmersISOPROPYL ALCOHOLPharmacy Value Alliance; LLC9d606fe6-ae57-724f-e053-2a95a90abffe2023-12-20WarningsExact identifier
application number: M014
CVS Ear Drops for SwimmersISOPROPYL ALCOHOLCVS Pharmacycc4614ee-5d6e-4a07-9826-aff12cc35abd2023-12-20WarningsExact identifier
application number: M014
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Randob Labs, Ltd.a9904b63-27a4-205c-e053-2995a90af7622023-12-19WarningsExact identifier
application number: M014
DDM Ear Drops for SwimmersISOPROPYL ALCOHOLDiscount Drug Mart5d565cbc-874b-41dc-e053-2991aa0a67872023-12-19WarningsExact identifier
application number: M014
TopCare Swimmers Ear DropsISOPROPYL ALCOHOLTOPCO ASSOCIATES9dccbc25-d954-f917-e053-2a95a90a0eff2023-12-18WarningsExact identifier
application number: M014
HEB Water Drying AidISOPROPYL ALCOHOLH E B5d5741f8-64fd-0a9a-e053-2991aa0a0b5e2023-12-18WarningsExact identifier
application number: M014
Best Choice Earwax Removal KitCARBAMIDE PEROXIDEValu Merchandisers, Co.f943ac0e-8171-446d-8c6c-69612b4826432023-12-15WarningsExact identifier
application number: M014
Quality Choice Earwax Removal KitCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.ba8d71b5-7f1f-44a5-ac5b-1f7ceeb028752023-12-15WarningsExact identifier
application number: M014
DISCOUNT drug mart FOOD FAIR earwax removal kitCARBAMIDE PEROXIDEDiscount Drug Mart83fdf4d6-3cdf-429d-b53d-80775a35d0c92023-12-15WarningsExact identifier
application number: M014
Discount Drug Mart Earwax Removal DropsCARBAMIDE PEROXIDEDiscount Drug Marte30c943e-bba5-4520-8f83-16bfa29ee1cf2023-12-15WarningsExact identifier
application number: M014
HUMCO Ear Drops for SwimmersISOPROPYL ALCOHOLHumco Holding Group, Inc.6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b22023-12-15WarningsExact identifier
application number: M014
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Humco Holding Group, Inca8c052d8-fb9c-09f2-e053-2a95a90a37af2023-12-15WarningsExact identifier
application number: M014
EAR DRYING AGENTISOPROPYL ALCOHOL 94.998% GLYCERIN 5%Rite Aid9b4299af-c1a2-43e6-90d4-25f4c89d1bef2023-12-15WarningsExact 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