FDA.reportPublic FDA data

1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Orabloc]

RxCUI
1091068
RxNorm name
1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Orabloc]
Display name
ORABLOC (Injectable)
Full name
1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Orabloc]
Term type
SBD
Status
Active
Strength
40-0.01 mg/ml
Dose form
Cartridge 1.8 ml
Route
Injectable
Updated
2026-11-08 10:01:51

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032011
Active start
032011
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
epinephrine0.01 MG / 1 MLepinephrineepinephrine
articaine hydrochloride40 MG / 1 MLarticainearticaine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Cartridge1649572

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
epinephrine3992
articaine592464

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STROrabloc 4 % / 1:100,000 in 1.8 mL Dental Cartridge1NAMES
RxNorm Name1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Orabloc]1NAMES
RxNorm SynonymOrabloc 4 % / 1:100,000 in 1.8 mL Dental Cartridge1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDd18424f0-a691-11dd-ad8b-0800200c9a661CODES
RxCUI10910681CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
45146-110-0145146-110Orabloc articaine hydrochloride and epinephrine bitartratePierrel S.p.A.NDA022466
45146-110-0245146-110Orabloc articaine hydrochloride and epinephrine bitartratePierrel S.p.A.NDA022466

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02246645146-110Orabloc articaine hydrochloride and epinephrine bitartrateNDAPierrel S.p.A.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
45146011001rxnav_ndcsyes
45146011002rxnav_ndcsyes
87566011001rxnav_historical
87566011002rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrablocARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPierrel S.p.A.d18424f0-a691-11dd-ad8b-0800200c9a662018-11-22Warnings, Adverse reactionsExact identifier
ndc (package): 45146-110-01
ndc (package): 45146-110-02
ndc (product): 45146-110
ndc11 (package): 45146011002
ndc11 (package): 45146011001
rxcui: 1091068

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d18424f0-a691-11dd-ad8b-0800200c9a66Orabloc 4 % / 1:100,000 in 1.8 mL Dental Cartridge [PSN] · 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [Orabloc] [SBD] · Orabloc 4 % / 1:100,000 in 1.8 mL Dental Cartridge [SY]320These highlights do not include all the information needed to use ORABLOC® safely and effectively. See full prescribing information for ORABLOC®. ORABLOC® (articaine HCl and epinephrine) injection, for intraoral submucosal infiltration use Initial U.S. Approval: 200020181122

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
905cade1-9b37-486a-ac12-21f3262ab4e2These highlights do not include all the information needed to use Articaine HCL and Epinephrine safely and effectively. See full prescribing information for Articaine HCL and Epinephrine. Articaine HCL and Epinephrine Injection, for intraoral submucosal infiltration use Initial U.S. Approval: 2000Aira LLC | Pierrel SPA20261027
905cade1-9b37-486a-ac12-21f3262ab4e2These highlights do not include all the information needed to use Articaine HCL and Epinephrine safely and effectively. See full prescribing information for Articaine HCL and Epinephrine. Articaine HCL and Epinephrine Injection, for intraoral submucosal infiltration use Initial U.S. Approval: 2000Aira LLC | Pierrel SPA20261015
905cade1-9b37-486a-ac12-21f3262ab4e2These highlights do not include all the information needed to use ORABLOC® safely and effectively. See full prescribing information for ORABLOC®. ORABLOC® (articaine HCl and epinephrine) injection, for intraoral submucosal infiltration use Initial U.S. Approval: 2000Aira LLC | Pierrel SPA20260922
905cade1-9b37-486a-ac12-21f3262ab4e2These highlights do not include all the information needed to use ORABLOC® safely and effectively. See full prescribing information for ORABLOC®. ORABLOC® (articaine HCl and epinephrine) injection, for intraoral submucosal infiltration use Initial U.S. Approval: 2000Aira LLC | Pierrel SPA20250701
d18424f0-a691-11dd-ad8b-0800200c9a66These highlights do not include all the information needed to use ORABLOC® safely and effectively. See full prescribing information for ORABLOC®. ORABLOC® (articaine HCl and epinephrine) injection, for intraoral submucosal infiltration use Initial U.S. Approval: 2000Pierrel S.p.A.20181122

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4epinephrine
ATCR03AAAlpha- and beta-adrenoreceptor agonistsATC1-4epinephrine
ATCN01BBAmidesATC1-4articaine
ATCB02BCLocal hemostaticsATC1-4epinephrine
ATCA01ADOther agents for local oral treatmentATC1-4epinephrine
ATCS01EASympathomimetics in glaucoma therapyATC1-4epinephrine
ATCR01AASympathomimetics, plainATC1-4epinephrine
FDASPLD000577AmidesCHEMhas_chemical_structurearticaine
FDASPLD002395CatecholaminesCHEMhas_chemical_structureepinephrine
FDASPLN0000175552alpha-Adrenergic AgonistEPChas_epcepinephrine
FDASPLN0000175682Amide Local AnestheticEPChas_epcarticaine
FDASPLN0000175555beta-Adrenergic AgonistEPChas_epcepinephrine
FDASPLN0000175570CatecholamineEPChas_epcepinephrine
FDASPLN0000000209Adrenergic alpha-AgonistsMOAhas_moaepinephrine
FDASPLN0000000245Adrenergic beta-AgonistsMOAhas_moaepinephrine
FDASPLN0000175976Local AnesthesiaPEhas_pearticaine
MEDRTD002355CarticaineCHEMhas_ingredientarticaine
MEDRTD004837EpinephrineCHEMhas_ingredientepinephrine
MEDRTD000402Airway ObstructionDISEASEmay_treatepinephrine
MEDRTD000707AnaphylaxisDISEASEmay_treatepinephrine
MEDRTD001145Arrhythmias, CardiacDISEASEci_withepinephrine
MEDRTD001919BradycardiaDISEASEmay_treatepinephrine
MEDRTD001986Bronchial SpasmDISEASEmay_treatepinephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withepinephrine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withepinephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatepinephrine
MEDRTD006323Heart ArrestDISEASEmay_treatepinephrine
MEDRTD006327Heart BlockDISEASEmay_treatepinephrine
MEDRTD006967HypersensitivityDISEASEci_witharticaine
MEDRTD006967HypersensitivityDISEASEci_witharticaine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatepinephrine
MEDRTD010146PainDISEASEmay_preventarticaine
MEDRTD010146PainDISEASEmay_treatarticaine
MEDRTD010146PainDISEASEmay_preventarticaine hydrochloride
MEDRTD010146PainDISEASEmay_treatarticaine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatepinephrine
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatepinephrine
MEDRTD014693Ventricular FibrillationDISEASEmay_treatepinephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaepinephrine
MEDRTN0000009921Adrenergic beta1-AgonistsMOAhas_moaepinephrine
MEDRTN0000009922Adrenergic beta2-AgonistsMOAhas_moaepinephrine
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moaarticaine
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moaarticaine hydrochloride
MEDRTN0000008298Arterial VasoconstrictionPEhas_peepinephrine
MEDRTN0000008322BronchodilationPEhas_peepinephrine
MEDRTN0000009944Decreased Intraocular Aqueous SecretionPEhas_peepinephrine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pearticaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pearticaine hydrochloride
MEDRTN0000009014Decreased Uterine Smooth Muscle Contraction or TonePEhas_peepinephrine
MEDRTN0000009070Hemostasis AlterationPEhas_peepinephrine
MEDRTN0000178478Increased Blood PressurePEhas_peepinephrine
MEDRTN0000009808Positive ChronotropyPEhas_peepinephrine
MEDRTN0000009809Positive InotropyPEhas_peepinephrine
MEDRTN0000009820Pupillary DilationPEhas_peepinephrine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH40 MG/ML / 0.01 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY1.8 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
CODESNDANDA022466
NAMESPrescribable SynonymOrabloc 4 % / 1:100,000 in 1.8 mL Dental Cartridge
NAMESTallman Synonym1.8 ML articaine hydrochloride 40 MG/ML / EPINEPHrine 0.01 MG/ML Cartridge [Orabloc]
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK