FDA.reportPublic FDA data

NDC 67239-0209-01 - Articaine HCl 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
67239-0209
Requested NDC
67239-0209-01
Package NDCs from labels
67239-0209-1, 67239-0209-01
Manufacturer
Safco Dental Supply Co. | PIERREL SPA
Effective date
2023-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Articaine HCl and Epinephrine - Safco Dental Supply Co. | PIERREL SPASafco Dental Supply Co. | PIERREL SPA2023-01-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67239-0209-1Articaine HCl and Epinephrine50 in 1 CARTONINJECTION507
67239-0209-1Articaine HCl and Epinephrine1.8 mL in 1 CARTRIDGEINJECTION1.87

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67239-0209ARTICAINE HCL AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [SAFCO DENTAL SUPPLY CO.]7Current NDC, Legacy NDC, 2 package rows20230220_0536a4de-578d-497e-a01b-0b1887344cc8.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 4 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirst971439ed-4507-7a30-e053-2a95a90a1f1c2024-01-22Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINELIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst94e9f2db-af29-032e-e053-2995a90a7f7b2024-01-22Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEA-S Medication Solutions38610ee9-4e70-4a8a-a5c5-6c148cf145f02023-12-04Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
SENSORCAINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb2023-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
Articaine HCl and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESafco Dental Supply Co.0536a4de-578d-497e-a01b-0b1887344cc82023-01-14Warnings, Adverse reactionsExact identifier
application number: NDA022466
ndc (package): 67239-0209-1
ndc (package): 67239-0210-1
ndc (product): 67239-0210
ndc (product): 67239-0209
ndc11 (package): 67239020901
rxcui: 1661483
rxcui: 1658966
spl id: 253a3ea1-c583-49d4-9655-b33ffa1115b0
spl set id: 0536a4de-578d-497e-a01b-0b1887344cc8
unii: 30Q7KI53AK
unii: QS9014Q792
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCdcf3c0ad-9eb8-4ee7-96df-d0db7ff231752022-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCba082c2f-64f4-419d-9c88-74f203316e172021-08-25Warnings, Adverse reactionsExact identifier
unii: 30Q7KI53AK
OrablocARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPierrel S.p.A.d18424f0-a691-11dd-ad8b-0800200c9a662018-11-22Warnings, Adverse reactionsExact identifier
application number: NDA022466
rxcui: 1661483
rxcui: 1658966
unii: 30Q7KI53AK
unii: QS9014Q792

Reported adverse events (FAERS/openFDA)#

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