Clinere Ear Wax Remover

Product NDC
68229-102
11-digit product format
682290102
Labeler code
68229
Product ID
68229-102_47e36138-722e-d71c-e063-6294a90a808e
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Quest Products
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-04
Substance
CARBAMIDE PEROXIDE
Active strength
.065 g/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
Clinere Ear Wax Remover
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE.065 g/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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d967eac3-0aac-a7ae-e053-2995a90a0e1eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-102-01Clinere Ear Wax Remover15 mL in 1 BOTTLELIQUID154
68229-102-02Clinere Ear Wax Remover1 in 1 CARTONLIQUID14
68229-102-03Clinere Ear Wax Remover2 in 1 CARTONLIQUID24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-102-02ML - Milliliter68229-102cb2b9467-aa84-4bce-8be1-cc2b8ebde26e12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-102CLINERE EAR WAX REMOVER (CARBAMIDE PEROXIDE) LIQUID [QUEST PRODUCTS]3Current NDC, Legacy NDC, 3 package rows20241107_d967eac3-0aac-a7ae-e053-2995a90a0e1e.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 SolutionPSNd967eac3-0aac-a7ae-e053-2995a90a0e1e4
702050carbamide peroxide 65 MG/ML Otic SolutionSCDd967eac3-0aac-a7ae-e053-2995a90a0e1e4
702050carbamide peroxide 6.5 % Otic SolutionSYd967eac3-0aac-a7ae-e053-2995a90a0e1e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68229-102-016822901020115 mL in 1 BOTTLE15 mlHistorical
68229-102-02682290102021 BOTTLE in 1 CARTON (68229-102-02) / 15 mL in 1 BOTTLE (68229-102-01) 1 bottle2022-03-040000-00-00NoNoCurrent
68229-102-03682290102032 BOTTLE in 1 CARTON (68229-102-03) / 15 mL in 1 BOTTLE (68229-102-01) 2 bottle2022-03-040000-00-00NoNoCurrent