FDA.reportPublic FDA data

Leader Earwax Removal Kit Earwax Removal Aid and Bulb

Product NDC
70000-0689
11-digit product format
700000689
Labeler code
70000
Product ID
70000-0689_1f7f89ab-ef7d-21dc-e063-6294a90ab82a
Type
HUMAN OTC DRUG
Nonproprietary name
CARBAMIDE PEROXIDE
Dosage form
KIT
Labeler
Cardinal Health 110 DBA Leader
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-09
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Earwax Removal Kit Earwax Removal Aid and Bulb
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui702050

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0688-1Leader Earwax Removal Kit Earwax Removal Aid and Bulb15 mL in 1 BOTTLESOLUTION/ DROPS15 mL65 mg in 1mL2
70000-0688-1Leader Earwax Removal Kit Earwax Removal Aid and Bulb1 in 1 BOXSOLUTION/ DROPS65 mg in 1mL2
70000-0689-1Leader Earwax Removal Kit Earwax Removal Aid and Bulb1 in 1 BOXKIT12
70000-0689-1Leader Earwax Removal Kit Earwax Removal Aid and Bulb1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0689LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB (CARBAMIDE PEROXIDE) KIT [CARDINAL HEALTH 110 DBA LEADER]2Current NDC, 4 package rows20240814_36c1408b-4287-4e9f-aa17-4f05add50038.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN36c1408b-4287-4e9f-aa17-4f05add500382
702050carbamide peroxide 65 MG/ML Otic SolutionSCD36c1408b-4287-4e9f-aa17-4f05add500382
702050carbamide peroxide 6.5 % Otic SolutionSY36c1408b-4287-4e9f-aa17-4f05add500382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0688-17000006880115 mL in 1 BOTTLE15 mlHistorical
70000-0689-1700000689011 KIT in 1 BOX (70000-0689-1) / 1 KIT in 1 KIT * 1 BOTTLE in 1 BOX (70000-0688-1) / 15 mL in 1 BOTTLE1 kit2024-07-09NoNoCurrent