LEADER Earwax Removal Kit

Product NDC
70000-0490
11-digit product format
700000490
Labeler code
70000
Product ID
70000-0490_f10cc38f-e49c-483c-e053-2a95a90a02e7
Type
HUMAN OTC DRUG
Nonproprietary name
carbamide peroxide 6.50% kit
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Cardinal Health, 110 dba Leader
Application
part344
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-05-06
Marketing end
0000-00-00
Substance
CARBAMIDE PEROXIDE
Active strength
7 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0490-1ML - Milliliter70000-04907cce8572-4d8e-48a1-939c-af181108cc6812020-06-05
70000-0490-2ML - Milliliter70000-04904eba040e-d0a2-4bdf-ac3c-05008edaa71012020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0490LEADER EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE 6.50% KIT) LIQUID [CARDINAL HEALTH, 110 DBA LEADER]9Legacy NDC20231223_883d65e1-78ab-be9d-e053-2a95a90aa591.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0490-1700000490011 BOTTLE, DROPPER in 1 CARTON (70000-0490-1) > 15 mL in 1 BOTTLE, DROPPER2019-05-060000-00-00NoNoCurrent
70000-0490-27000004900215 mL in 1 CONTAINER (70000-0490-2) 15 ml2019-05-060000-00-00NoNoCurrent