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 9 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMK.C. Pharmaceuticals, Inc.9ddfc275-602f-413b-e053-2995a90a11cb2025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops Seasonal ReliefTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEKC Pharmaceuticals, Inc.92bd8cb4-90ad-4a47-afa4-30d1fa658d622025-12-30WarningsExact identifier
application number: M018
DG Health Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLDolgencorp LLC9c62f8a3-7cf5-40f9-e053-2a95a90afd862025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops Original Redness RelieverTETRAHYDROZOLINE HYDROCHLORIDEKC Pharmaceuticals, Inc.e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be2025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEK.C. Pharmaceuticals, Inc.f7131707-47af-d70a-e053-6394a90a418f2025-12-30WarningsExact identifier
application number: M018
DG Original Eye DropsTETRAHYDROZOLINE HCLDolgencorp LLC9cb2123c-3ed4-ce8f-e053-2995a90a0ab82025-12-30WarningsExact identifier
application number: M018
Artificial TearsPOLYVINYL ALCOHOL, POVIDONEKC Pharmaceuticals, Inc.eb6eb6c4-1609-407b-84e4-c7509811f3c02025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
application number: M018
Medics Choice Fresh and Soothe Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKC Pharmaceuticals, Inc.1f65b91a-4eac-65c2-e063-6394a90a02952025-12-30WarningsExact identifier
application number: M018
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
application number: M018
DG Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLDolgencorp LLC9cb27899-6c36-3c37-e053-2995a90a1d432025-12-30WarningsExact identifier
application number: M018
Publix Artificial Tears Eye DropsPOLYVINYL ALCOHOL, POVIDONEPublix Super Markets, Inc.f5d1394b-0fe8-c372-e053-2a95a90a1f782025-12-30WarningsExact identifier
application number: M018
Best Choice Artificial TearsPOLYVINYL ALCOHOL, POVIDONEBest Choicef5ba63f3-7966-81fe-e053-2995a90a342c2025-12-30WarningsExact identifier
application number: M018
DG Maximum Strength Redness ReliefGLYCERIN, NAPHAZOLINE HCLDolgencorp, Inc9cb261ed-b708-1189-e053-2a95a90a547d2025-12-30WarningsExact identifier
application number: M018
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
application number: M018
Publix Moisturizing Relief Eye DropsCARBOXYMETHYLCELLULOSE SODIUMPublix Super Markets, Inc.9b391400-c53b-7c7b-e053-2995a90a27312025-12-30WarningsExact identifier
application number: M018
Publix High Performance Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLPublix Super Markets, Inc.9b402aa8-87cb-3928-e053-2995a90afa3c2025-12-30WarningsExact identifier
application number: M018
Kroger Eye Drops Artificial TearsPOLYVINYL ALCOHOL, POVIDONEThe Kroger Companyf76f08c5-0111-8bc5-e053-6294a90a16ee2025-12-30WarningsExact identifier
application number: M018
Health Mart Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCc8be678f-2b4a-4d39-9cb4-910d36d721742025-12-30WarningsExact identifier
application number: M018
Winco Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWinCo Foods, LLCff3651d4-42ce-4db1-a318-15f7592baf862025-12-30WarningsExact 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