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 8 of 73 · 1,444 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISTIFY SEA SALT CARAMEL HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fce390-6b53-f9f7-e063-6294a90aa44f2026-06-24WarningsExact identifier
unii: F5UM2KM3W7
MISTIFY CHERRY CRUSH HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fd0c49-bf20-c2e3-e063-6294a90a56402026-06-24WarningsExact identifier
unii: F5UM2KM3W7
MISTIFY VANILLA CUPCAKE HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54fd0885-0d8c-614d-e063-6394a90acef92026-06-24WarningsExact identifier
unii: F5UM2KM3W7
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MISTIFY SWEET STRAWBERRY HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd55042fdb-ce19-2396-e063-6394a90a99862026-06-24WarningsExact identifier
unii: F5UM2KM3W7
VANILL HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd54e9d23b-45e5-5e53-e063-6394a90a60662026-06-23WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.3ca0168d-8945-907a-e063-6294a90a9deb2026-06-23WarningsExact identifier
unii: F5UM2KM3W7
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.54def395-2f22-20a4-e063-6294a90a61962026-06-22WarningsExact identifier
unii: F5UM2KM3W7
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
unii: F5UM2KM3W7
DoveANTIBACTERIAL CARE BEAUTY BARConopco d/b/a Unilever547472cf-4902-584e-e063-6294a90a28ac2026-06-17WarningsExact identifier
unii: F5UM2KM3W7
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Brimonidine Tartrate and Timolol maleate Ophthalmic SolutionBRIMONIDINE TARTRATE AND TIMOLOL MALEATEGland Pharma Limited038cf2ba-ad08-4981-a3cc-bff0e4ba5dfb2026-06-16Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEWildman Business Group1fd15b91-6b81-d0bd-e063-6294a90a4d272026-06-15WarningsExact identifier
unii: F5UM2KM3W7
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
GLOBAL CARE GOLD ANTIBACTERIAL HANDBENZALKONIUM CHLORIDENINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.540bde3c-5af2-456a-e063-6294a90aa7742026-06-12WarningsExact identifier
unii: F5UM2KM3W7
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepack09dbed18-9076-4891-93a7-d14bb22179262026-06-12Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEFlorida Pharmaceutical Products, LLC02d89d37-cbca-4e06-83ef-2a10f988f1ea2026-06-12Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R

Reported adverse events (FAERS/openFDA)#

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