FDA.reportPublic FDA data

Leader Original Eye Drops

Product NDC
70000-0454
11-digit product format
700000454
Labeler code
70000
Product ID
70000-0454_e00b9d59-7cac-17b7-e053-2a95a90a6d79
Type
HUMAN OTC DRUG
Nonproprietary name
Tetrahydrozoline HCl
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Cardinal Health
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-02-19
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70000-0454DDiscontinued by firm2026-08-10
excluded packagepackage70000-045470000-0454-1DDiscontinued by firm2026-08-10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0454-1ML - Milliliter70000-0454ba96d49d-b719-47c4-a239-087a65a280c212019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0454LEADER ORIGINAL EYE DROPS (TETRAHYDROZOLINE HCL) SOLUTION/ DROPS [CARDINAL HEALTH]6Legacy NDC20240103_aec2ef95-0b9b-48dd-8809-73d19e309e4f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0454-1700000454011 BOTTLE, PLASTIC in 1 CARTON (70000-0454-1) > 15 mL in 1 BOTTLE, PLASTIC2019-02-190000-00-00NoNoCurrent