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 3 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
application number: M018
Nano Eye Drop SerumWATER. SORBITOL.1.2-HEXANEDIOL GLYCERIN HYALURONATESODIUM.Shenzhen Yiyang Zhiting Technology Co., Ltd539567d6-488a-9b01-e063-6394a90abece2026-06-06WarningsExact identifier
application number: M018
REFRESH CELLUVISCCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.b32ed9e8-d091-4f16-b416-5a62cdfee49a2026-06-05WarningsExact identifier
application number: M018
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
application number: M018
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
application number: M018
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
application number: M018
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
application number: M018
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
application number: M018
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
application number: M018
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
application number: M018
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporatedf1d07347-086f-43b2-aa5f-910764fc666e2026-05-13WarningsExact identifier
application number: M018
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
application number: M018
Sodium Hyaluronate Eye DropsSODIUM HYALURONATEGuangzhou Hechuang Commercial Service Co.,Ltd.5187d136-15c6-517b-e063-6294a90a811d2026-05-11WarningsExact identifier
application number: M018
Splash TearsHYPROMELLOSELABORATORIOS SOPHIA, S.A. DE C.V.a58a8478-9cc5-aa39-e053-2995a90a347d2026-05-08WarningsExact identifier
application number: M018
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
application number: M018
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
application number: M018
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact 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