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 65 of 195 · 3,896 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
Melancholy Drops Extrovert 2015MELANCHOLY DROPS EXTROVERTProfessional Complementary Health Formulas2c9187ce-a52e-445e-a36e-fe374f5ad2e22026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops Introvert 2016MELANCHOLY DROPS INTROVERTProfessional Complementary Health Formulas60e305b4-bb1f-465e-963d-38e6b38df98d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Stim Liquescence 3028SPLEEN STIM LIQUESCENCEProfessional Complementary Health Formulas463b62a5-4d4f-445f-ba24-859195730cab2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops 2002MELANCHOLY DROPSProfessional Complementary Health Formulas96d7f202-c19b-4914-96bb-9906ad781ad02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Natrum Muriaticum 8009NATRUM MURIATICUMProfessional Complementary Health Formulasb4a48b58-28c0-4368-83e8-40ce52ae5f2b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Aletris Combination 9203ALETRIS COMBINATIONProfessional Complementary Health Formulas87ae7310-927b-48fe-b659-6f93dad623632026-01-08WarningsExact identifier
unii: 451W47IQ8X
Adalimumab-aacfADALIMUMABFresenius Kabi USA, LLC2488b0bc-7b8f-4cc8-91ea-48e7ea5e89152026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: 451W47IQ8X
EcoChoice Sterno Hand Sanitizer Lemon ZestALCOHOLSTERNO PRODUCTS, LLC576b7579-f44d-4315-a9c6-09d9a6d3f61d2026-01-07WarningsExact identifier
application number: M003
EcoChoice Sterno Hand Sanitizer Clean and FreshALCOHOLSTERNO PRODUCTS, LLC6647babe-1d1a-4a23-9042-66d950355c812026-01-07WarningsExact identifier
application number: M003
Biopure Anti-bacterial Hand Wipes Honey Wildflower ScentBENZALKONIUM CHLORIDEQuest USA Corp47d11556-764e-5429-e063-6294a90a3dca2026-01-07WarningsExact identifier
application number: M003
Biopure Antibacterial Hand Wipe Juicy WatermelonBENZALKONIUM CHLORIDEQuest USA Corp47d53645-4ba8-0cdc-e063-6294a90a38922026-01-07WarningsExact identifier
application number: M003
Biopure Antibacterial Hand Wipe Berry StrawberryBENZALKONIUM CHLORIDEQuest USA Corp47d6574c-0d4c-392e-e063-6394a90a590f2026-01-07WarningsExact identifier
application number: M003
Biopure Antibacterial Hand Wipe Vallina DreamBENZALKONIUM CHLORIDEQuest USA Corp47d7090d-036b-870b-e063-6394a90a80c32026-01-07WarningsExact identifier
application number: M003
BLT-25 KitBUPIVACAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDINE IODINEAsclemed USA, Inc.87307801-d970-41cf-ad1e-d89b0ff8549f2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1737566
Sodium chlorideSODIUM CHLORIDEBECTON DICKINSON AND COMPANYd39b7307-df67-4e68-acb0-2eda5dc612152026-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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