FDA.reportPublic FDA data

NDC 60758-802-15 - TIMOLOL MALEATE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
60758-802
Requested NDC
60758-802-15
Package NDCs from labels
60758-802-05, 60758-802-10, 60758-802-15
Manufacturer
Pacific Pharma, Inc.
Effective date
2024-03-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TIMOLOL MALEATE ophthalmic solution , USP 0.25% and 0.5% sterilePacific Pharma, Inc.2024-03-14HUMAN PRESCRIPTION DRUG LABEL
TIMOLOL MALEATE ophthalmic solution, USP 0.25% and 0.5% sterileREMEDYREPACK INC.2021-01-21HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60758-802-05TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS116
60758-802-05TIMOLOL MALEATE5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS516
60758-802-10TIMOLOL MALEATE10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1016
60758-802-10TIMOLOL MALEATE1 in 1 CARTONSOLUTION/ DROPS116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60758-802TIMOLOL MALEATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]15Current NDC, Legacy NDC, 4 package rows20240404_e16c33fd-aa86-49ad-a767-c79ade4a62c7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60758-802-05ML - Milliliter60758-802110df675-4374-458d-9c60-07abed44726812012-07-24
60758-802-10ML - Milliliter60758-802551ca5cf-d93e-467a-a0f3-e70acb42bd6512012-07-24
60758-802-15ML - Milliliter60758-8022e20d110-9f47-49f3-8d2d-ab7c6ae568a012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
timolol maleateACTIVE INGREDIENTP8Y54F701RTIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC. ]8
timolol anhydrousACTIVE MOIETY5JKY92S7BRTIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC. ]8
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC. ]8
hydrochloric acidINACTIVE INGREDIENTQTT17582CBTIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC. ]8
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC. ]8
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC. ]8
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWTIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC. ]8
waterINACTIVE INGREDIENT059QF0KO0RTIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC. ]8

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 73 · 1,453 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zoono Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEZoono Holdings USA LLCb4dcfd0f-e3b6-a7e9-e053-2a95a90a56c82026-07-31WarningsExact identifier
unii: F5UM2KM3W7
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BIOPURE50CT ANTI BACTERIAL HAND WIPESBIOPURE50CT ANTI BACTERIAL HAND WIPESZhejiang Furuisen Spunlaced Nonwovens Co., Ltd57d3e290-1343-4075-e063-6394a90a41a62026-07-30WarningsExact identifier
unii: F5UM2KM3W7
Jelly SmackBENZALKONIUM CHLORIDEVULCAN MICROBIAL CORPORATIONeb79e11a-6c29-556b-e053-2a95a90a728a2026-07-29WarningsExact identifier
unii: F5UM2KM3W7
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsExact identifier
unii: F5UM2KM3W7
AEROAIDBENZALKONIUM CHLORIDEAero Healthcare US LLCc9d55d86-0a4e-4c44-96e8-8d13fd16c54d2026-07-24WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, FreshBENZALKONIUM CHLORIDEQuest USA Corp5719809b-1c74-4bf3-e063-6294a90ab0082026-07-23WarningsExact identifier
unii: F5UM2KM3W7
KeepGoing Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJ&A Digital Inc.1a6303ce-8df7-4e8b-93f2-e162fdd2540c2026-07-22WarningsExact identifier
unii: F5UM2KM3W7
Germfree24 Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incfb43545b-6ddc-49fb-86dd-17cd1a925a782026-07-22WarningsExact identifier
unii: F5UM2KM3W7
Pharma-Care Skin Preparation ClothsBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc324ec648-59f9-46c2-ab7a-7ec6ba42dd422026-07-22WarningsExact identifier
unii: F5UM2KM3W7
My-Shield Hand SanitizerBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc0c73f042-47e5-4eba-ba59-52aabf8f45312026-07-22WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
unii: F5UM2KM3W7
MY-SHIELD SANITIZINGBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc91655320-7d8e-4024-b8f3-511d33d059f92026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Germ-Free 24 SanitizingBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc1ef9c150-f885-4b0e-8b69-82c4832fab912026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd503a2db-e326-4a31-bc6a-5034ad74bf0b2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
MY-SHIELD TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incc2c1f5d9-cd6e-4314-9dfc-961ed877c2932026-07-21WarningsExact identifier
unii: F5UM2KM3W7
DOCTOR INKS HAND SANITIZERBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Ince174f231-73df-464b-bd92-23222659df242026-07-21WarningsExact identifier
unii: F5UM2KM3W7
My-Shield Sanitizing Hand WipesBENZALKONIUM CHLORIDEENVIRO SPECIALTY CHEMICALS INCea99c72e-1881-498a-a653-29bac1dab97b2026-07-21WarningsExact identifier
unii: F5UM2KM3W7
Softsoap Antibacterial with Moisturizers Crisp Clean LHSBENZALKONIUM CHLORIDEColgate-Palmolive Company7e978e04-9b1a-44ef-b082-429a6a7520282026-07-21WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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