Quality Choice Earwax Removal Drops

Product NDC
63868-027
11-digit product format
638680027
Labeler code
63868
Product ID
63868-027_52f67d50-4482-6e0f-e063-6394a90a7877
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-27
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
Quality Choice Earwax Removal 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 · 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
d8fd8102-114f-415d-9083-f98a63f9d1b3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-027-16Quality Choice Earwax Removal Drops15 mL in 1 BOTTLE, DISPENSINGLIQUID153
63868-027-16Quality Choice Earwax Removal Drops1 in 1 CARTONLIQUID13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-027-16ML - Milliliter63868-0275cc1a2c0-19a9-49d7-9275-8bfc0dcba64e12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-027QUALITY CHOICE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION, INC.]3Current NDC, Legacy NDC, 2 package rows20231215_d8fd8102-114f-415d-9083-f98a63f9d1b3.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 SolutionPSNd8fd8102-114f-415d-9083-f98a63f9d1b34
702050carbamide peroxide 65 MG/ML Otic SolutionSCDd8fd8102-114f-415d-9083-f98a63f9d1b34
702050carbamide peroxide 6.5 % Otic SolutionSYd8fd8102-114f-415d-9083-f98a63f9d1b34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-027-16638680027161 BOTTLE, DISPENSING in 1 CARTON (63868-027-16) / 15 mL in 1 BOTTLE, DISPENSING2014-11-270000-00-00NoNoCurrent