FDA.reportPublic FDA data

1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge

RxCUI
1661483
RxNorm name
1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge
Display name
Articaine/EPINEPHrine (Injectable)
Full name
1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge
Term type
SCD
Status
Active
Strength
40-0.01 mg/ml
Dose form
Cartridge 1.8 ml
Route
Injectable
Updated
2026-11-08 10:03:12

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092015
Active start
092015
Multiple ingredient
YES
Branded
NO

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_STR1.8 ML articaine hydrochloride 40 MG/ML / EPINEPHrine 0.01 MG/ML Cartridge1NAMES
RxNorm Name1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge1NAMES
RxNorm Synonymarticaine HCl 4 % / epinephrine 1:100,000 in 1.8 mL Dental Cartridge1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI16614831CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
43498-816-0143498-816Articaine Hydrochloride and Epinephrine ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATEBurkhart Dental Supply Co., IncNDA022466
67239-0209-167239-0209Articaine HCl and Epinephrine articaine hydrochloride and epinephrine bitartrateSafco Dental Supply Co.NDA022466

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02246643498-816Articaine Hydrochloride and Epinephrine ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATENDA AUTHORIZED GENERICBurkhart Dental Supply Co., Inc

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
43498081601rxnav_ndcsyes
67239020901rxnav_ndcsyes
87566011002rxnav_ndcsyes
72304001500rxnav_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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATEBurkhart Dental Supply Co., Inc4f11bb06-c71b-4d96-9baa-2a17ad473a052024-11-18Warnings, Adverse reactionsExact identifier
ndc (package): 43498-816-01
ndc (product): 43498-816
ndc11 (package): 43498081601
rxcui: 1661483
Articaine HCl and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESafco Dental Supply Co.0536a4de-578d-497e-a01b-0b1887344cc82023-01-14Warnings, Adverse reactionsExact identifier
ndc (package): 67239-0209-1
ndc (product): 67239-0209
ndc11 (package): 67239020901
rxcui: 1661483
OrablocARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPierrel S.p.A.d18424f0-a691-11dd-ad8b-0800200c9a662018-11-22Warnings, Adverse reactionsExact identifier
rxcui: 1661483

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 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d18424f0-a691-11dd-ad8b-0800200c9a66articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge [PSN] · 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [SCD] · articaine HCl 4 % / epinephrine 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
0536a4de-578d-497e-a01b-0b1887344cc8articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge [PSN] · 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [SCD] · articaine HCl 4 % / epinephrine 1:100,000 in 1.8 mL Dental Cartridge [SY]37These 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: 200020230114
4f11bb06-c71b-4d96-9baa-2a17ad473a05articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge [PSN] · 1.8 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge [SCD] · articaine HCl 4 % / epinephrine 1:100,000 in 1.8 mL Dental Cartridge [SY]34These 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 Hydrochloride 4% and Epinephrine 1:100,000 Injection (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use Initial U.S. Approval: 200020241118

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
4f11bb06-c71b-4d96-9baa-2a17ad473a05These 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 Hydrochloride 4% and Epinephrine 1:100,000 Injection (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use Initial U.S. Approval: 2000Burkhart Dental Supply Co., Inc | Pierrel S.p.A.20241118
0536a4de-578d-497e-a01b-0b1887344cc8These 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: 2000Safco Dental Supply Co. | PIERREL SPA20230114
be742506-8c6e-6ff2-e053-2995a90a6b21These 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 Hydrochloride 4% and Epinephrine 1:100,000 Injection Articaine Hydrochloride 4% and Epinephrine 1:200,000 Injection (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use Initial U.S. Approval: 2000Midway Dental Supply, LLC20221212

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
NAMESPrescribable Synonymarticaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
NAMESTallman Synonym1.8 ML articaine hydrochloride 40 MG/ML / EPINEPHrine 0.01 MG/ML Cartridge
NAMESTallman Synonymarticaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
SOURCESSourceMetathesaurus FDA Structured Product Labels