Orabloc
- Product NDC
- 87566-110
- 11-digit product format
- 875660110
- Labeler code
- 87566
- Product ID
- 87566-110_5c156e98-2b12-2d9a-e063-6394a90a98b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- articaine hydrochloride and epinephrine bitartrate
- Dosage form
- INJECTION
- Route
- SUBMUCOSAL
- Labeler
- Aira LLC
- Application
- NDA022466
- Marketing category
- NDA
- Marketing start
- 2026-09-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022466-001 | ORABLOC | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2010-02-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022466-002 | ORABLOC | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2010-02-26 | caaa826d4ba7… | |
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Orabloc
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ARTICAINE HYDROCHLORIDE | 40 mg/mL |
| EPINEPHRINE BITARTRATE | 10 ug/mL |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Articaine Hydrochloride and Epinephrine | ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE | Burkhart Dental Supply Co., Inc | 4f11bb06-c71b-4d96-9baa-2a17ad473a05 | 2024-11-18 | Warnings, Adverse reactions | 022466 NDA022466 |
| Articaine HCl and Epinephrine | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Safco Dental Supply Co. | 0536a4de-578d-497e-a01b-0b1887344cc8 | 2023-01-14 | Warnings, Adverse reactions | 022466 NDA022466 |
| Orabloc | ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Pierrel S.p.A. | d18424f0-a691-11dd-ad8b-0800200c9a66 | 2018-11-22 | Warnings, Adverse reactions | 022466 NDA022466 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87566-110-01 | 87566011001 | 100 CARTRIDGE in 1 BOX (87566-110-01) / 1.8 mL in 1 CARTRIDGE | 100 cartridge | 2026-09-15 | No | No | Current |
| 87566-110-02 | 87566011002 | 50 CARTRIDGE in 1 BOX (87566-110-02) / 1.8 mL in 1 CARTRIDGE | 50 cartridge | 2026-09-15 | No | No | Current |