FDA.reportPublic FDA data

Major LubriFresh PM

Product NDC
0904-6488
Requested package NDC
0904-6488-38
11-digit product format
009046488
Labeler code
0904
Product ID
0904-6488_e9d7299a-4f70-2d3c-e053-2995a90a73db
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral oil and White petrolatum
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Major Pharmaceuticals
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-09-11
Marketing end
0000-00-00
Substance
MINERAL OIL; PETROLATUM
Active strength
150 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 packagepackage0904-64880904-6488-38DDiscontinued by firm2026-09-14

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6488-38Major LubriFresh PM3.5 g in 1 TUBEOINTMENT3.513
0904-6488-38Major LubriFresh PM1 in 1 CARTONOINTMENT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6488-38GM - Gram0904-6488ce39ea21-96ea-4be8-bcd1-efba1e59eacf12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPMAJOR LUBRIFRESH PM (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [MAJOR PHARMACEUTICALS]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UMAJOR LUBRIFRESH PM (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [MAJOR PHARMACEUTICALS]1
MINERAL OILACTIVE MOIETYT5L8T28FGPMAJOR LUBRIFRESH PM (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [MAJOR PHARMACEUTICALS]1
PETROLATUMACTIVE MOIETY4T6H12BN9UMAJOR LUBRIFRESH PM (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [MAJOR PHARMACEUTICALS]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEMAJOR LUBRIFRESH PM (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6488MAJOR LUBRIFRESH PM (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [MAJOR PHARMACEUTICALS]12Legacy NDC, 2 package rows20240318_bd85d4b6-7093-4e89-ae7b-2a293a0775f2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6488-38009046488381 TUBE in 1 CARTON (0904-6488-38) > 3.5 g in 1 TUBE1 tube2015-09-110000-00-00NoNoCurrent