FDA.reportPublic FDA data

NDC 12862-1050 - Septocaine

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
12862-1050
Package NDCs from labels
12862-1050-1, 12862-1050-2
Manufacturer
SEPTODONT, Inc.
Effective date
2006-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Septocaine - SEPTODONT, Inc.SEPTODONT, Inc.2006-12-26HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12862-1050-1Septocaine50 in 1 CANINJECTION, SOLUTION501
12862-1050-1Septocaine1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.71
12862-1050-2Septocaine50 in 1 BOXINJECTION, SOLUTION501
12862-1050-2Septocaine1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12862-1050SEPTOCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]14 package rows20070906_FBB95791-D582-4FB4-81DF-3084EB069B10.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12862-1050-2ML - Milliliter12862-10502ae38083-7140-4797-af4f-de18543a5b5d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Articaine HydrochlorideACTIVE INGREDIENTQS9014Q792SEPTOCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]1
Epinephrine bitartrateACTIVE INGREDIENT30Q7KI53AKSEPTOCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]1
articaineACTIVE MOIETYD3SQ406G9XSEPTOCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]1
epinephrineACTIVE MOIETYYKH834O4BHSEPTOCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XSEPTOCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]1
Sodium hydroxideINACTIVE INGREDIENT55X04QC32ISEPTOCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]1
Sodium metabisulfiteINACTIVE INGREDIENTSEPTOCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.]1

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 ยท 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.636cbf11-819c-48f8-915d-ac5fb38bd3522026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 1595035
Septocaine and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESeptodont Inc.0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce032024-10-23Warnings, Adverse reactionsExact identifier
rxcui: 861588
rxcui: 1595035
ZorcaineARTICAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.1767d606-69b8-419e-840f-36550ed91b8f2024-03-06Warnings, Adverse reactionsExact identifier
rxcui: 1595035
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENDC, Inc.0b0cbbec-8216-434f-892e-226c89d7239c2024-03-06Warnings, Adverse reactionsExact identifier
rxcui: 1595035
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.cc7ff594-2204-44b2-8f81-bcb9c7e9360b2024-03-06Warnings, Adverse reactionsExact identifier
rxcui: 1595035
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.f26a084b-ab25-4ca2-8f58-705a4219bf322024-03-06Warnings, Adverse reactionsExact identifier
rxcui: 1595035
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEPatterson Dental406de6e6-40f5-44c5-a109-3be0b9d48e582024-03-06Warnings, Adverse reactionsExact identifier
rxcui: 1595035
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEBenco Dentald47d7842-930e-41db-9631-d1aba0f05ae02024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 1595035
Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINEHenry Scheind9402ac2-fedd-4fb0-90a3-2c466a7865262024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 1595035
ArticadentARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDentsply Pharmaceutical9ca8fb43-4f34-47c0-8b79-3b5bd1eaee002024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 1595035
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.854399ec-f7d6-4eab-87bb-94c2b442ec3e2024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 1595035
82AA93B8-5FFD-C05B-50FB-62495993D605FBB95791-D582-4FB4-81DF-3084EB069B102006-12-26Warnings, Adverse reactionsExact identifier
spl id: 82AA93B8-5FFD-C05B-50FB-62495993D605
spl set id: FBB95791-D582-4FB4-81DF-3084EB069B10

Reported adverse events (FAERS/openFDA)#

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