FDA.reportPublic FDA data

NDC 60505-1003-01 - Ketorolac Tromethamine

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
60505-1003
Requested NDC
60505-1003-01
Package NDCs from labels
60505-1003-1, 60505-1003-2, 60505-1003-01
Manufacturer
Apotex Corp.
Effective date
2026-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketorolac Tromethamine - Apotex Corp.Apotex Corp.2026-07-16HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2025-07-31HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - Redpharm DrugRedpharm Drug2024-07-03HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2024-05-30HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - Proficient Rx LPProficient Rx LP2022-11-01HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - A-S Medication SolutionsA-S Medication Solutions2021-04-15HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2020-06-19HUMAN PRESCRIPTION DRUG LABEL
KETOROLAC TROMETHAMINE - DIRECT RXDIRECT RX2019-10-30HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - Medsource PharmaceuticalsMedsource Pharmaceuticals2018-12-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-1003-1Ketorolac Tromethamine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS513
60505-1003-1Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS113
60505-1003-2Ketorolac Tromethamine1 in 1 CARTONSOLUTION/ DROPS113
60505-1003-2Ketorolac Tromethamine10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-1003KETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]11Current NDC, Legacy NDC, 4 package rows20240927_d9a186ba-74a9-b6d4-1109-1e045ba1763e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-1003-1ML - Milliliter60505-10039242ed86-ca0a-4b36-8ca2-eba63b8be90312012-07-24
60505-1003-2ML - Milliliter60505-1003b5119ae4-e5cf-48d3-8cc5-8eeb4fe10e6712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
KetorolacACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7KETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
OCTOXYNOL-40INACTIVE INGREDIENT9T1C662FKSKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6
WATERINACTIVE INGREDIENT059QF0KO0RKETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]6

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 2 of 118 · 2,345 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Swisher Advanced Antibacterial Foam HandsoapBENZALKONIUM CHLORIDEEcolab Inc.38bd6680-db95-424c-8e84-2e12c2388a732026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a28101f-ea8e-6071-e063-6294a90aad912026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a3e62ce-52dc-121b-e063-6294a90a898f2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a49db18-c270-6f46-e063-6294a90afb5d2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a4ac18e-8ba5-bef6-e063-6394a90a88112026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a4d11fa-3f65-b41f-e063-6394a90a30ae2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsExact identifier
unii: 451W47IQ8X
BMNP Nat MurNATRUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a57ccfd-ab6f-cb2c-e063-6394a90ae9e62026-08-31WarningsExact identifier
unii: 451W47IQ8X
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.04d5114e-332b-4ed0-85df-b276c1dc296c2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
unii: F5UM2KM3W7
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLC6758cb38-dec8-468f-94e2-613772e39b9a2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59ed87d5-dab1-abab-e063-6394a90a024d2026-08-26WarningsExact identifier
unii: F5UM2KM3W7
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fa27b4-dfd4-720b-e063-6394a90af6592026-08-26WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fb22d6-f6a4-42cd-e063-6394a90a859a2026-08-26WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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