Family Care Earwax Removal

Product NDC
65923-639
11-digit product format
659230639
Labeler code
65923
Product ID
65923-639_41c7b5be-d04d-cad3-e063-6294a90ae421
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide Peroxide
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
United Exchange Corp.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-22
Substance
CARBAMIDE PEROXIDE
Active strength
.065 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
Family Care Earwax Removal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE.065 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-639-15Family Care Earwax Removal15 mL in 1 BOTTLE, DROPPERLIQUID154
65923-639-15Family Care Earwax Removal1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-639FAMILY CARE EARWAX REMOVAL (CARBAMIDE PEROXIDE) LIQUID [UNITED EXCHANGE CORP.]3Current NDC, Legacy NDC, 2 package rows20241226_958741f5-47c1-339c-e053-2a95a90a3f5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN958741f5-47c1-339c-e053-2a95a90a3f5f4
702050carbamide peroxide 65 MG/ML Otic SolutionSCD958741f5-47c1-339c-e053-2a95a90a3f5f4
702050carbamide peroxide 6.5 % Otic SolutionSY958741f5-47c1-339c-e053-2a95a90a3f5f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65923-639-15659230639151 BOTTLE, DROPPER in 1 CARTON (65923-639-15) / 15 mL in 1 BOTTLE, DROPPER2019-10-220000-00-00NoNoCurrent