Quality Choice Earwax Removal Drops

Product NDC
63868-027
11-digit product format
638680027
Labeler code
63868
Product ID
63868-027_0c868adb-99ab-5c7a-e063-6394a90a6638
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
2026-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

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

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