ARTICAINE

Product NDC
66975-418
11-digit product format
669750418
Labeler code
66975
Product ID
66975-418_fb0a499d-51ad-4dc6-ae5a-6818450cc952
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Articaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
SUBMUCOSAL
Labeler
Benco Dental
Application
NDA020971
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-04-04
Substance
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength
40; .005 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020971-001SEPTOCAINEARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03
N020971-002SEPTOCAINEARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONAPRLD, RS2000-04-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-03782e0a99824c…
2021-12-28 21:50 UTC2021-12N020971-002SEPTOCAINE4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2006-03-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020971-001SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)INJECTABLE / INJECTIONRLD, RS2000-04-0387673890dc5c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020971-001AP174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020971-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N020971-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020971-001AP1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
ARTICAINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTICAINE HYDROCHLORIDE40 mg/mL
EPINEPHRINE BITARTRATE.005 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QS9014Q792Internal UNII lookup
30Q7KI53AKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1595029Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4524cb96-40f7-471f-bfc6-1dcab47628ecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-418-51ARTICAINE50 in 1 CARTONINJECTION, SOLUTION507
66975-418-51ARTICAINE1.7 mL in 1 CARTRIDGEINJECTION, SOLUTION1.77

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66975-418ARTICAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [BENCO DENTAL]7Current NDC, Legacy NDC, 2 package rows20240302_4524cb96-40f7-471f-bfc6-1dcab47628ec.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 1 of 1 · 16 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
application applno (NDA): 020971
application number: NDA020971
Septocaine and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESeptodont Inc.0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce032024-10-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.fc908011-5e5e-459a-a666-d414265047032024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ZorcaineARTICAINE HYDROCHLORIDE AND EPINEPHRINESeptodont, Inc.1767d606-69b8-419e-840f-36550ed91b8f2024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEPatterson Dental2b5a7ee3-71ee-4c41-ad9f-852f170470b32024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENDC, Inc.0b0cbbec-8216-434f-892e-226c89d7239c2024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.cc7ff594-2204-44b2-8f81-bcb9c7e9360b2024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.f26a084b-ab25-4ca2-8f58-705a4219bf322024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEPatterson Dental406de6e6-40f5-44c5-a109-3be0b9d48e582024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENDC, Inc.60d11ba2-e9e0-4f0a-bdfc-3bc49006c2df2024-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEBenco Dentald47d7842-930e-41db-9631-d1aba0f05ae02024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
Articaine Hydrochloride and EpinephrineARTICAINE HYDROCHLORIDE AND EPINEPHRINEHenry Scheind9402ac2-fedd-4fb0-90a3-2c466a7865262024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ArticadentARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDentsply Pharmaceutical9ca8fb43-4f34-47c0-8b79-3b5bd1eaee002024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.c4bba4ab-2b20-43e6-92ea-9ec6f1fce7542024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINENovocol Pharmaceutical of Canada, Inc.854399ec-f7d6-4eab-87bb-94c2b442ec3e2024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ARTICAINEARTICAINE HYDROCHLORIDE AND EPINEPHRINEBenco Dental4524cb96-40f7-471f-bfc6-1dcab47628ec2024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020971
application number: NDA020971
ndc (product): 66975-418

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595029articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.7 mL Dental CartridgePSN4524cb96-40f7-471f-bfc6-1dcab47628ec7
15950291.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML CartridgeSCD4524cb96-40f7-471f-bfc6-1dcab47628ec7
1595029articaine HCl 4 % / epinephrine 1:200,000 1.7 ML CartridgeSY4524cb96-40f7-471f-bfc6-1dcab47628ec7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66975-418-516697504185150 CARTRIDGE in 1 CARTON (66975-418-51) / 1.7 mL in 1 CARTRIDGE50 cartridge2016-04-040000-00-00NoNoCurrent