FDA.reportPublic FDA data

Leader Lubricant Eye Drops

Product NDC
70000-0455
Requested package NDC
70000-0455-2
11-digit product format
700000455
Labeler code
70000
Product ID
70000-0455_efe4ba84-eb93-59c8-e053-2a95a90a86f9
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene glycol, propylene glycol
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
POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength
0 g/100mL; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-045570000-0455-2DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70000-045570000-0455-2DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70000-045570000-0455-2DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0455-1ML - Milliliter70000-0455d888937c-b0b6-4e57-91ab-55b03965438c12019-08-06
70000-0455-2ML - Milliliter70000-0455b4641f73-5bd6-442f-9003-dd1dea25a77c12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0455LEADER LONG LASTING LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CARDINAL HEALTH]5Legacy NDC20240104_0a7c0f59-dd38-4dba-bd04-af1ec75d6569.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0455-2700000455022 BOTTLE, DROPPER in 1 BOX (70000-0455-2) > 15 mL in 1 BOTTLE, DROPPER2019-04-290000-00-00NoNoCurrent