FDA.reportPublic FDA data

CVS Health Earwax Removal Kit

Product NDC
51316-823
11-digit product format
513160823
Labeler code
51316
Product ID
51316-823_52f5c6f4-95ea-d093-e063-6394a90a037c
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
KIT
Labeler
CVS Pharmacy, Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-01
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
CVS Health Earwax Removal Kit
Listing expiration
2027-12-31

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
f842534c-46dd-42c7-8386-9a03ce16da86Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-822-00CVS Health Earwax Removal Kit15 mL in 1 BOTTLESOLUTION/ DROPS15 mL65 mg in 1mL1
51316-822-00CVS Health Earwax Removal Kit1 in 1 BOXSOLUTION/ DROPS65 mg in 1mL1
51316-823-00CVS Health Earwax Removal Kit1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-823CVS HEALTH EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) KIT [CVS PHARMACY, INC.]1Current NDC, 3 package rows20240802_f842534c-46dd-42c7-8386-9a03ce16da86.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 2 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoloEarCARBAMIDE PEROXIDEPharmadel LLC352df636-0469-c33e-e063-6294a90a22242026-03-26WarningsExact identifier
application number: M014
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
application number: M014
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
application number: M014
Ear Wash Refill CVSCARBAMIDE PEROXIDECVS311c5951-949c-b38b-e063-6294a90aa4a92026-02-27WarningsExact identifier
application number: M014
ProRinse Earwax Removal SystemCARBAMIDE PEROXIDEMcKeon Products Incca82db28-1ef7-41c6-a46b-7bfc7b09281c2026-02-09WarningsExact identifier
application number: M014
Wax Away Earwax Removal AidCARBAMIDE PEROXIDEMcKeon Products Inc8e6c8bf3-d3ec-4605-b8e5-47612f94db892026-02-09WarningsExact identifier
application number: M014
Wax Away Earwax Removal SystemCARBAMIDE PEROXIDEMcKeon Products Inc22c6f7db-814b-4e70-9fbe-bbb86385d0702026-02-09WarningsExact identifier
application number: M014
blue goo FREEZING PAIN RELIEF Topical AnalgesicMENTHOL 4%Garcoa, Inc.e90e35e8-47a7-4f9b-ba8a-1cfd15b439952026-02-06WarningsExact identifier
application number: M014
CaseysDishwashingSoapDISHWASHING DETERGENT JUNIPER FORESTKYNC DESIGN LLCb563af92-606c-7c12-e053-2a95a90abbb72026-01-23WarningsExact identifier
application number: M014
CaseysLavenderCASEYS HAND SOAP LAVENDER SCENTKYNC Design LLCb5bc8770-13ef-36dc-e053-2995a90a3f512026-01-23WarningsExact identifier
application number: M014
Les Coja Organic SPF 30ETHYLHEXYL SALICYLATE, HOMOSALATE, BUTYL METHOXYDIBENZOYLMETHANERNA PHARMA, LLC485d31e4-a2a9-8165-e063-6294a90a14fc2026-01-14WarningsExact identifier
application number: M014
Clinere Ear Wax RemoverCARBAMIDE PEROXIDEQuest Productsd967eac3-0aac-a7ae-e053-2995a90a0e1e2026-01-08WarningsExact identifier
application number: M014
Deluxe Ear Wash systemCARBAMIDE PEROXIDEWalgreens14923bf4-5b4f-a26a-e063-6294a90aa6b52025-12-10WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%GeriCare Pharmaceutical Corp239702af-cf93-43ee-b1af-8e53642395c12025-12-09WarningsExact identifier
application number: M014
EELHOE Whole Body Deodorant Solid BalmGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.45696491-3c41-39c6-e063-6394a90abae32025-12-07WarningsExact identifier
application number: M014
Texture ID Anti Dandruff Peppermint Oil and Aloe ConditionerSALICYLIC ACIDRNA PHARMA, LLC450dff05-9410-5366-e063-6294a90ae0d42025-12-03WarningsExact identifier
application number: M014
Texture ID Anti Dandruff Oil TreatmentSALICYLIC ACIDRNA PHARMA, LLC450ec8ae-2405-8d2f-e063-6394a90a50db2025-12-03WarningsExact identifier
application number: M014
Texture ID Anti Dandruff Peppermint Oil and AloeSALICYLIC ACIDRNA PHARMA, LLC44fa5eed-93e2-cb3a-e063-6294a90a3b042025-12-02WarningsExact identifier
application number: M014
Ear Wash Refill EquateCARBAMIDE PEROXIDEWalmart404619f5-4b99-03a7-e063-6294a90a3f412025-12-01WarningsExact identifier
application number: M014
JAYSUING Silicone Scar GelGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.427f80f2-e2a5-b824-e063-6294a90a95342025-11-27WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNf842534c-46dd-42c7-8386-9a03ce16da862
702050carbamide peroxide 65 MG/ML Otic SolutionSCDf842534c-46dd-42c7-8386-9a03ce16da862
702050carbamide peroxide 6.5 % Otic SolutionSYf842534c-46dd-42c7-8386-9a03ce16da862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-822-005131608220015 mL in 1 BOTTLE15 mlHistorical
51316-823-00513160823001 KIT in 1 KIT (51316-823-00) * 1 BOTTLE in 1 BOX (51316-822-00) / 15 mL in 1 BOTTLE1 kit2024-08-01NoNoCurrent