Home NDC 67239-0209 Articaine HCl and Epinephrine
Product NDC 67239-0209
11-digit product format 672390209
Labeler code 67239
Product ID 67239-0209_253a3ea1-c583-49d4-9655-b33ffa1115b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name articaine hydrochloride and epinephrine bitartrate
Dosage form INJECTION
Route SUBMUCOSAL
Labeler Safco Dental Supply Co.
Application NDA022466
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-06-01
Substance ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength 40; 10 mg/mL; ug/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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022466-001 ORABLOC ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 N022466-002 ORABLOC ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022466-001 ORABLOC 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) INJECTABLE / INJECTION RLD 2010-02-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022466-002 ORABLOC 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2010-02-26 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Articaine HCl and Epinephrine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARTICAINE HYDROCHLORIDE 40 mg/mL EPINEPHRINE BITARTRATE 10 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 30Q7KI53AK Internal UNII lookup QS9014Q792 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1658966 Internal RxNorm lookup 1661483 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67239-0209-1 Articaine HCl and Epinephrine 50 in 1 CARTON INJECTION 50 7 67239-0209-1 Articaine HCl and Epinephrine 1.8 mL in 1 CARTRIDGE INJECTION 1.8 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67239-0209 ARTICAINE HCL AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION [SAFCO DENTAL SUPPLY CO.] 7 Current NDC, Legacy NDC, 2 package rows 20230220_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 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67239-0209-1 67239020901 50 CARTRIDGE in 1 CARTON (67239-0209-1) / 1.8 mL in 1 CARTRIDGE 50 cartridge 2016-06-01 0000-00-00 No No Current