FDA.reportPublic FDA data

Leader Nighttime Relief Lubricant Eye

Product NDC
70000-0724
11-digit product format
700000724
Labeler code
70000
Product ID
70000-0724_308772fc-d6f7-da9f-e063-6394a90a41db
Type
HUMAN OTC DRUG
Nonproprietary name
Light Mineral Oil, White Petrolatum
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
LEADER/Cardinal Health 110, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-12
Substance
LIGHT MINERAL OIL; WHITE PETROLATUM
Active strength
425; 573 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Nighttime Relief Lubricant Eye
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIGHT MINERAL OIL425 mg/g
WHITE PETROLATUM573 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN6K5787QVP, B6E5W8RQJ4
Rxcui702008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0724-1Leader Nighttime Relief Lubricant Eye1 in 1 BOXOINTMENT11
70000-0724-1Leader Nighttime Relief Lubricant Eye3.5 g in 1 TUBEOINTMENT3.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0724-1GM - Gram70000-07246c853217-91c7-44b5-bcfe-12fe80cc994b12026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0724LEADER NIGHTTIME RELIEF LUBRICANT EYE (LIGHT MINERAL OIL, WHITE PETROLATUM) OINTMENT [LEADER/CARDINAL HEALTH 110, INC.]1Current NDC, 2 package rows20250319_308772fc-d6f6-da9f-e063-6394a90a41db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702008mineral oil 42.5 % / petrolatum 57.3 % Ophthalmic OintmentPSN308772fc-d6f6-da9f-e063-6394a90a41db1
702008mineral oil 0.425 MG/MG / petrolatum 0.573 MG/MG Ophthalmic OintmentSCD308772fc-d6f6-da9f-e063-6394a90a41db1
702008mineral oil 42.5 % / petrolatum, white 57.3 % Ophthalmic OintmentSY308772fc-d6f6-da9f-e063-6394a90a41db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0724-1700000724011 TUBE in 1 BOX (70000-0724-1) / 3.5 g in 1 TUBE1 tube2025-03-12NoNoHistorical