FDA.reportPublic FDA data

Altalube

Product NDC
59390-198
11-digit product format
593900198
Labeler code
59390
Product ID
59390-198_0c0e9c0d-6205-e63b-e063-6294a90ac0d9
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral oil and petrolatum
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Altaire Pharmaceuticals Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-02-01
Substance
MINERAL OIL; PETROLATUM
Active strength
150; 850 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
Altalube
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL150 mg/g
PETROLATUM850 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T5L8T28FGPInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
579996Internal RxNorm lookup
1088146Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb65004c-c3a7-4079-bd75-f2857d30c68aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59390-198-50Altalube1 in 1 CARTONOINTMENT14
59390-198-50Altalube3.5 g in 1 TUBEOINTMENT3.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59390-198-50GM - Gram59390-19803cbe75b-f0c3-46ac-ab50-9a6f687181b712018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59390-198ALTALUBE (MINERAL OIL AND PETROLATUM) OINTMENT [ALTAIRE PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20231214_eb65004c-c3a7-4079-bd75-f2857d30c68a.zip

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
1088146Altalube 15 % / 85 % Ophthalmic OintmentPSNeb65004c-c3a7-4079-bd75-f2857d30c68a4
579996mineral oil 15 % / petrolatum 85 % Ophthalmic OintmentPSNeb65004c-c3a7-4079-bd75-f2857d30c68a4
1088146mineral oil 0.15 MG/MG / petrolatum 0.85 MG/MG Ophthalmic Ointment [Altalube]SBDeb65004c-c3a7-4079-bd75-f2857d30c68a4
579996mineral oil 0.15 MG/MG / petrolatum 0.85 MG/MG Ophthalmic OintmentSCDeb65004c-c3a7-4079-bd75-f2857d30c68a4
1088146Altalube (mineral oil 15 % / petrolatum, white 85 % ) Ophthalmic OintmentSYeb65004c-c3a7-4079-bd75-f2857d30c68a4
579996mineral oil 15 % / white petrolatum 85 % Ophthalmic OintmentSYeb65004c-c3a7-4079-bd75-f2857d30c68a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59390-198-50593900198501 TUBE in 1 CARTON (59390-198-50) / 3.5 g in 1 TUBE1 tube2002-02-010000-00-00NoNoCurrent