FDA.reportPublic FDA data

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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact 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