FDA.reportPublic FDA data

NDC 63323-487-01 - XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)

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
63323-487
Requested NDC
63323-487-01
Package NDCs from labels
63323-487-01, 63323-487-17, 63323-487-07, 63323-487-37, 63323-487-03, 63323-487-31
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2024-01-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LIDOCAINE HYDROCHLORIDE ANHYDROUS - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-22HUMAN PRESCRIPTION DRUG LABEL
Xylocaine MPF - Fresenius Kabi USA, LLC | Fresenius Kabi AustriaFresenius Kabi USA, LLC | Fresenius Kabi Austria2021-08-25HUMAN PRESCRIPTION DRUG LABEL
D-Care 100XRX PHARMA-PACK, INC.2020-01-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-487-01XylocaineMPF10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1013
63323-487-03XylocaineMPF30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3013
63323-487-07XylocaineMPF30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3013
63323-487-17XylocaineMPF25 in 1 TRAYINJECTION, SOLUTION2513
63323-487-31XylocaineMPF5 in 1 CARTONINJECTION, SOLUTION513
63323-487-37XylocaineMPF25 in 1 TRAYINJECTION, SOLUTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-487XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]13Current NDC, Legacy NDC, 6 package rows20210831_ba082c2f-64f4-419d-9c88-74f203316e17.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-487-01ML - Milliliter63323-487abacec98-8d14-4aa0-aa91-b6665598d9d412020-04-20
63323-487-03ML - Milliliter63323-48731057550-cb80-49a9-8868-2ad97e93ffd412021-08-05
63323-487-07ML - Milliliter63323-48768a4710a-174b-475a-b197-3f4825c0e10712019-12-10
63323-487-17ML - Milliliter63323-487c42ff282-3515-499f-92e8-5ecfb162219f12012-07-24
63323-487-31ML - Milliliter63323-487cad5209d-3130-4dc4-be24-70f0e8b8a58612012-07-24
63323-487-37ML - Milliliter63323-4878363510f-c58b-4562-9d74-c40d7177fc6b12012-07-24
63323-487-92ML - Milliliter63323-487d35b690d-19f4-45c3-aaca-382312b925bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
EPINEPHRINEACTIVE MOIETYYKH834O4BHXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
LIDOCAINEACTIVE MOIETY98PI200987XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CXYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION XYLOCAINE MPF (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]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 25 of 196 · 3,917 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedThermal ALCOHOL PREP PADISOPROPYL ALCOHOLCarelife (USA) Inc.fc9d6344-be68-484f-984b-8c7f39b6034d2026-06-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
GeriGentle Alcohol PadsISOPROPYL ALCOHOLGeri-Gentle Corporation05cda9fa-e503-6e37-e063-6394a90a27112026-06-05WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Povidone-IodinePOVIDONE-IODINEH E B4a7a627c-505d-992b-e063-6394a90a54ca2026-06-04Warnings, Adverse reactionsExact identifier
application number: M003
unii: 85H0HZU99M
GNP Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLAmerisource Bergen03247512-7a31-4fb4-b7e0-efc337cab6932026-06-04WarningsExact identifier
application number: M003
unii: ND2M416302
Povidone IodinePOVIDONE-IODINEAmerisource Bergenf69a5cec-04f2-4028-94c6-1f129d2de5a92026-06-04WarningsExact identifier
application number: M003
unii: 85H0HZU99M
GNP Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLAmerisource Bergen0ffd9643-3bc2-4b04-92c5-80fe5e429a252026-06-04WarningsExact identifier
application number: M003
unii: ND2M416302
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356d350-1325-7299-e063-6294a90a96a02026-06-03WarningsExact identifier
unii: 451W47IQ8X
OP First Aid Series Insect Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.b43af183-834a-0f64-e053-2995a90a32182026-06-03WarningsExact identifier
unii: ND2M416302
Maokang Povidone-Iodine Paint Solution AntisepticPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd48f81109-3791-46ef-8992-d53b677a51b62026-06-02WarningsExact identifier
unii: 85H0HZU99M
OptiSource Sterile Alcohol Prep PadsISOPROPYL ALCOHOL7051395 Canada Ince49c9ddf-7743-443e-ba85-ee90785f0c722026-06-02WarningsExact identifier
rxcui: 797544
unii: ND2M416302
PESI VANILLA HYDRATIING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53325d04-26db-fc62-e063-6394a90a322a2026-06-01WarningsExact identifier
application number: M003
KOOL AID PPINK LEMONADE HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53342b67-8742-1387-e063-6394a90acc742026-06-01WarningsExact identifier
application number: M003
ICEE CHERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53352f95-6477-25e3-e063-6394a90a9e022026-06-01WarningsExact identifier
application number: M003
JOLLY RANCHER BLUE RASPBERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53357f28-a843-ec12-e063-6294a90a16fc2026-06-01WarningsExact identifier
application number: M003
SOURPATCHKIDS STRAWBERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53358c4e-3021-1e85-e063-6294a90a07382026-06-01WarningsExact identifier
application number: M003
GUSHERS TROPICAL HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53359191-0451-a1a0-e063-6394a90a81a12026-06-01WarningsExact identifier
application number: M003
MOUNTAIN DEW HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53359746-6033-c3d2-e063-6394a90a677c2026-06-01WarningsExact identifier
application number: M003
FLUFFY STUFF COTTON CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5335d246-5c4c-6773-e063-6294a90a8ffa2026-06-01WarningsExact identifier
application number: M003
DUBBLE BUBBLE ORIGINAL FLAVOR BUBBLE GUM HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5335d97d-3d8e-fc86-e063-6394a90abaad2026-06-01WarningsExact identifier
application number: M003
MISTIFY PUMPKIN HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e262fe-9a91-59c2-e063-6394a90ac32a2026-06-01WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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