FDA.reportPublic FDA data

Leader Lubricant Eye

Product NDC
70000-0513
Requested package NDC
70000-0513-1
11-digit product format
700000513
Labeler code
70000
Product ID
70000-0513_ed3608a1-359e-c207-e053-2995a90a46ac
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil, and White Petrolatum
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Leader
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-08-30
Marketing end
0000-00-00
Substance
MINERAL OIL; PETROLATUM
Active strength
425 mg/g; mg/g
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 packagepackage70000-051370000-0513-1DDiscontinued by firm2026-10-05

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
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70000-051370000-0513-1IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70000-051370000-0513-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-05-21Leader Lubricant Eye Ointment
2024-01-30Leader Lubricant Eye Ointment
2021-02-01Leader Lubricant Eye Ointment
2021-01-29Leader Lubricant Eye Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0513-1Leader Lubricant Eye3.5 g in 1 TUBEOINTMENT3.59
70000-0513-1Leader Lubricant Eye1 in 1 BOXOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0513-1GM - Gram70000-05136e3efd08-bd98-41f8-b3fb-c6ddbe8f053e12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0513LEADER LUBRICANT EYE (MINERAL OIL, AND WHITE PETROLATUM) OINTMENT [LEADER]8Legacy NDC, 2 package rows20240522_91816ca9-4c5a-8a93-e053-2a95a90a280f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0513-1700000513011 TUBE in 1 BOX (70000-0513-1) > 3.5 g in 1 TUBE1 tube2019-08-300000-00-00NoNoCurrent