FDA.reportPublic FDA data

NDC 70518-4237-01 - 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
70518-4237
Requested NDC
70518-4237-01
Package NDCs from labels
70518-4237-1, 70518-4237-0, 70518-4237-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketorolac Tromethamine - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4237-0Ketorolac Tromethamine25 in 1 CARTONINJECTION, SOLUTION251
70518-4237-1Ketorolac Tromethamine1 mL in 1 VIALINJECTION, SOLUTION11

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 188 of 196 · 3,910 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multiple Electrolytes pH 5.5SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEFresenius Kabi USA, LLCcf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c2022-11-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SpectricETHYLICUM, KALI BROMATUM, ASPARTIC ACID, L-DOPA, SEROTONIN (HYDROCHLORIDE), CEREBRUM SUIS, PLACENTA TOTALIS SUIS, AGARICUS MUSCARIUS, BUFO RANA, HELLEBORUS NIGER, HYOSCYAMUS NIGER, OLIBANUM (BOSWELLIA SERRATA), STRAMONIUM, THUJA OCCIDENTALIS, HELIUM, NEON, CARCINOSIN, HYDROGENDeseret Biologicals, Inc3e534017-4a9f-42a2-bdfd-1e8c73c0515a2022-11-08WarningsExact identifier
unii: 3K9958V90M
Natrum MuriaticumNATRUM MURIATICUMHahnemann Laboratories, INC.ecf06f13-012c-212d-e053-2995a90a71982022-11-08Exact identifier
unii: 451W47IQ8X
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEATNAHS PHARMA US LIMITED57ea681c-392e-4f41-a374-91ed204731612022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEProficient Rx LP2f27e304-7a96-47b6-8ef1-8a649c25abcf2022-11-01Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC51da05ce-e3c4-4ef5-a845-dc869152e17f2022-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ketorolac TromethamineKETOROLAC TROMETHAMINECamber Pharmaceuticals, Inc.e1fb8753-4695-4cb2-83d7-15d79fbaeeb22022-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Ketorolac TromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.004588ba-e109-4a53-9c9d-a42dea9bb8482022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
unii: 4EVE5946BQ
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ketorolac TromethamineKETOROLAC TROMETHAMINEFresenius Kabi USA, LLCccf905ca-e164-4779-9485-2d139c821bad2022-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1665459
rxcui: 860092
rxcui: 1665461
unii: 4EVE5946BQ
Dr Talbots Infant Daily Allergy ReliefALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bdcc8a-c947-ff5d-e053-2a95a90a3b922022-09-12WarningsExact identifier
unii: 451W47IQ8X
Ketorolac tromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.ee44c322-4b4b-4397-a1a5-e5b3c3c5a0532022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204216
rxcui: 1665459
unii: 4EVE5946BQ
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLC6a1322c7-7767-4569-aa22-9d2e363312832022-08-30WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Nighttime Grape FlavorONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e676dbb7-212f-47e3-e053-2995a90af4e12022-08-17WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Daytime Grape FlavorONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFURHyland's Consumer Health Inc.e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d2022-08-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist PediaMedsSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5b580-1d9f-3081-e053-2995a90a80312022-08-08WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse BreatheSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5c313-046f-b0a7-e053-2a95a90a2a072022-08-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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