FDA.reportPublic FDA data

NDC 70518-4161-01 - 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
70518-4161
Requested NDC
70518-4161-01
Package NDCs from labels
70518-4161-0, 70518-4161-1, 70518-4161-2, 70518-4161-3, 70518-4161-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketorolac Tromethamine Tablets, USP Rx onlyREMEDYREPACK INC.2026-08-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4161-0Ketorolac Tromethamine1 in 1 BOTTLE, PLASTICTABLET, FILM COATED15
70518-4161-1Ketorolac Tromethamine20 in 1 BOTTLE, PLASTICTABLET, FILM COATED205
70518-4161-2Ketorolac Tromethamine10 in 1 BOTTLE, PLASTICTABLET, FILM COATED105
70518-4161-3Ketorolac Tromethamine12 in 1 BOTTLE, PLASTICTABLET, FILM COATED125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4161KETOROLAC TROMETHAMINE TABLET, FILM COATED [REMEDYREPACK INC.]3Current NDC, 4 package rows20240927_04d5114e-332b-4ed0-85df-b276c1dc296c.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 80 of 137 · 2,736 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
unii: 15FIX9V2JP
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
City Skin Age Defense Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMurad, LLCf8c572a2-b4bc-49e9-95df-359f05bd69b72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM238SANTONINE, CINA, SILICEA, INDIGO, AMBROSIA, CUCCURBITA CIT, CUCCURBITA PEPBestmade Natural Products298fb9e2-3f98-01e6-e063-6294a90a7aaf2025-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM60CIMICIFUGAD6, DROSERAD6, FORMICA RUFAD6, FULIGOD6, INULA HELD6, KALI MURD6, LAPIS ALBUSD6, SILICEAD6Bestmade Natural Products29912fb7-8712-18d9-e063-6394a90a82f72025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb7d184fb-4a9a-4720-9b00-bf0caa257a8c2025-03-25WarningsExact identifier
unii: 15FIX9V2JP
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0ce809a1-45fb-9d4d-e063-6294a90a26a22025-03-23WarningsExact identifier
unii: 15FIX9V2JP
Natural Eyes Stye Relief Fast Dissolving TablesAPIS MELLIFICA, CARBONEUM SULPHURATUM, PULSATILLA, SEPIA, SILICEATRP Company30a5435b-32b0-807d-e063-6294a90a84da2025-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
EMF Protect and BalanceALFALFA, CADMIUM SULPHURATUM, CALCAREA CARBONICA, CUPRUM METALLICUM, FERRUM METALLICUM, FUCUS VESICULOSUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, SILICEA, SYMPHYTUM OFFICINALE, TARENTULA HISPANA, X-RAY, YTTERBIUM OXIDEDeseret Biologicals, Inc.00a2c1c7-2c04-4c71-9276-24ba87288d612025-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
unii: 15FIX9V2JP
Ketorolac TromethamineKETOROLAC TROMETHAMINEPD-Rx Pharmaceuticals, Inc.add10ccd-c205-4512-9619-253290fa11522025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 15FIX9V2JP
Ketorolac TromethamineKETOROLAC TROMETHAMINEBionpharma Inc.eda4b884-527c-42d3-971b-4d1678e5adbf2025-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA216759
ndc (product): 69452-275
rxcui: 834022
spl id: 2f9eead4-1b34-d484-e063-6294a90afd42
spl set id: eda4b884-527c-42d3-971b-4d1678e5adbf
unii: 4EVE5946BQ
Bestmade Natural Products BM231ABROTANUM, ANTI IOD, ARSENIC IOD, BARYTA CARB, CALC PHOS, FERR MET, KALI IOD, SILICEABestmade Natural Products2f81507c-b5b0-a976-e063-6394a90a869e2025-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM237BELLADONA, BARYTA CARB, HEPAR SULPH, KALI BICH, MERC IOD FLAV, MERC IOD RUB, SILICEABestmade Natural Products2f82f2c4-a549-9e17-e063-6394a90aea812025-03-04WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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