FDA.reportPublic FDA data

LubriFresh PM

Product NDC
0904-7540
11-digit product format
009047540
Labeler code
0904
Product ID
0904-7540_3ab32e69-b8db-f187-e063-6294a90afa9a
Type
HUMAN OTC DRUG
Nonproprietary name
Light Mineral Oil, White Petrolatum
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Major Pharmaceuticals
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-21
Substance
LIGHT MINERAL OIL; WHITE PETROLATUM
Active strength
150; 830 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
LubriFresh PM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIGHT MINERAL OIL150 mg/g
WHITE PETROLATUM830 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N6K5787QVPInternal UNII lookup
B6E5W8RQJ4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
746083Internal RxNorm lookup
1086613Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ab32e69-b8da-f187-e063-6294a90afa9aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7540-12LubriFresh PM3.5 g in 1 TUBEOINTMENT3.51
0904-7540-12LubriFresh PM1 in 1 BOXOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7540-12GM - Gram0904-7540f19c9858-22de-48b2-9f7f-b2c1d9faf7be12025-09-12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRedicare LLC4d1e5089-22b0-7b3f-e063-6294a90a346a2026-03-16WarningsExact identifier
application number: M018
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
application number: M018
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
application number: M018
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
application number: M018
Focus PIHYPROMELLOSE EYE DROPS 0.7%COVALENT MEDICALe9b2afdd-049a-3987-e053-2a95a90a6cbb2026-03-09WarningsExact identifier
application number: M018
Rain Renewal Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRain Eye Drops, LLCbb451b22-c4f6-291d-e053-2a95a90a78012026-03-06WarningsExact identifier
application number: M018
Complete Eye Relief Sterile Lubricant Eye DropsHYDROXYETHYL CELLULOSESimilasan Corporation4c49493a-70f9-0fde-e063-6394a90aea202026-03-05WarningsExact identifier
application number: M018
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
application number: M018
Irritated Eye Relief Sterile Lubricant Eye DropsHYDROXYETHYL CELLULOSESimilasan Corporation4c4ddcdf-3037-c9cd-e063-6294a90a16d52026-03-05WarningsExact identifier
application number: M018
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
application number: M018
Discount Drug Mart Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMDiscount Drug Mart4ba1b369-54e2-5224-e063-6394a90a47692026-02-25WarningsExact identifier
application number: M018
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4bafa882-50b7-e3e2-e063-6294a90a76e32026-02-25WarningsExact identifier
application number: M018
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
application number: M018
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
application number: M018
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
application number: M018
OptaseWHITE PETROLATUM, LANOLINScope Health Incc1991caa-51b9-13d1-e053-2995a90a12932026-01-31WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086613LubriFresh P.M. 15 % / 83 % Ophthalmic OintmentPSN3ab32e69-b8da-f187-e063-6294a90afa9a1
746083mineral oil 15 % / petrolatum 83 % Ophthalmic OintmentPSN3ab32e69-b8da-f187-e063-6294a90afa9a1
1086613mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic Ointment [Lubrifresh P.M.]SBD3ab32e69-b8da-f187-e063-6294a90afa9a1
746083mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic OintmentSCD3ab32e69-b8da-f187-e063-6294a90afa9a1
1086613Lubrifresh PM (mineral oil 15 % / white petrolatum 83 % ) Ophthalmic OintmentSY3ab32e69-b8da-f187-e063-6294a90afa9a1
746083mineral oil 15 % / petrolatum, white 83 % Ophthalmic OintmentSY3ab32e69-b8da-f187-e063-6294a90afa9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7540-12009047540121 TUBE in 1 BOX (0904-7540-12) / 3.5 g in 1 TUBE1 tube2025-07-21NoNoCurrent