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 4 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
application number: M018
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
application number: M018
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
application number: M018
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
application number: M018
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
application number: M018
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
application number: M018
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
application number: M018
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsExact identifier
application number: M018
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
application number: M018
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
application number: M018
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsExact identifier
application number: M018
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
application number: M018
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
application number: M018
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
application number: M018
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
application number: M018
NOVEHA NIGHTTIMEWHITE PETROLATUMBullet Point LLC4da24578-e98b-8ce1-e063-6294a90a8bf62026-03-24WarningsExact identifier
application number: M018
BLINK TRIPLE CAREPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporateda2b34eb0-001b-4f42-a8cc-c2a0150fafcc2026-03-20WarningsExact identifier
application number: M018
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
application number: M018
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
application number: M018
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4d1d9b3a-ac5f-db27-e063-6294a90afc3f2026-03-16WarningsExact 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