Articaine Hydrochloride and Epinephrine

Product NDC: 0404-6620
11-digit product format: 004046620
Labeler code: 0404
Product ID: 0404-6620_67eba8ba-c8c4-43f5-a482-88e4c0c355a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Articaine Hydrochloride and Epinephrine
Dosage form: INJECTION, SOLUTION
Route: SUBMUCOSAL
Labeler: Henry Schein
Application: NDA020971
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-01-28
Substance: ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength: 40; .01 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0404-6620		D	Discontinued by firm		2026-08-03
excluded package	package	0404-6620	0404-6620-30	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0404-6620-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0404-6620-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0404-6620-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0404-6620-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0404-6620-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0404-6620-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0404-6620-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0404-6620-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0404-6620-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0404-6620-30	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0404-6620-30	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0404-6620-30	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0404-6620-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0404-6620-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0404-6620-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
N020971-001	SEPTOCAINE	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03
N020971-002	SEPTOCAINE	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30

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
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	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020971-002	SEPTOCAINE	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2006-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020971-001	SEPTOCAINE	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)	INJECTABLE / INJECTION		RLD, RS	2000-04-03	`87673890dc5c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020971-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020971-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020971-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020971-001	AP	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Articaine Hydrochloride and Epinephrine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARTICAINE HYDROCHLORIDE	40 mg/mL
EPINEPHRINE BITARTRATE	.01 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QS9014Q792	Internal UNII lookup
30Q7KI53AK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1595029	Internal RxNorm lookup
1595035	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d9402ac2-fedd-4fb0-90a3-2c466a786526	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0404-6620-30	2021-11-02	C162847	48780-1	9d75b9cf-ecc0-f424-e053-dadaa90a57ce	These 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 1:200,000 Articaine hydrochloride 4% and epinephrine 1:100,000 (articaine HCl and epinephrine) Injection; Intraoral Submucosal Injection Initial U.S. Approval: 2000
0404-6620-30	2020-01-31	C162847	48780-1	9d75b9cf-ecc0-f424-e053-dadaa90a57ce	These 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 1:200,000 Articaine hydrochloride 4% and epinephrine 1:100,000 (articaine HCl and epinephrine) Injection; Intraoral Submucosal Injection Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-6620-05	Articaine Hydrochloride and Epinephrine	50 in 1 CARTON	INJECTION, SOLUTION	50		11
0404-6620-05	Articaine Hydrochloride and Epinephrine	1.7 mL in 1 CARTRIDGE	INJECTION, SOLUTION	1.7		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Articaine Hydrochloride	ACTIVE INGREDIENT	QS9014Q792	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]	3
Epinephrine Bitartrate	ACTIVE INGREDIENT	30Q7KI53AK	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]	3
Articaine	ACTIVE MOIETY	D3SQ406G9X	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]	3
Epinephrine	ACTIVE MOIETY	YKH834O4BH	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]	3
Sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]	3
Sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-6620	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN]	11	Current NDC, Legacy NDC, 2 package rows	20240302_d9402ac2-fedd-4fb0-90a3-2c466a786526.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Articaine Hydrochloride and Epinephrine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	636cbf11-819c-48f8-915d-ac5fb38bd352	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
Septocaine and Epinephrine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Septodont Inc.	0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce03	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	fc908011-5e5e-459a-a666-d41426504703	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
Zorcaine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	1767d606-69b8-419e-840f-36550ed91b8f	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Patterson Dental	2b5a7ee3-71ee-4c41-ad9f-852f170470b3	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	NDC, Inc.	0b0cbbec-8216-434f-892e-226c89d7239c	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	cc7ff594-2204-44b2-8f81-bcb9c7e9360b	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	f26a084b-ab25-4ca2-8f58-705a4219bf32	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Patterson Dental	406de6e6-40f5-44c5-a109-3be0b9d48e58	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	NDC, Inc.	60d11ba2-e9e0-4f0a-bdfc-3bc49006c2df	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Benco Dental	d47d7842-930e-41db-9631-d1aba0f05ae0	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
Articaine Hydrochloride and Epinephrine	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Henry Schein	d9402ac2-fedd-4fb0-90a3-2c466a786526	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971 ndc (product): 0404-6620
Articadent	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Dentsply Pharmaceutical	9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	c4bba4ab-2b20-43e6-92ea-9ec6f1fce754	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Novocol Pharmaceutical of Canada, Inc.	854399ec-f7d6-4eab-87bb-94c2b442ec3e	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971
ARTICAINE	ARTICAINE HYDROCHLORIDE AND EPINEPHRINE	Benco Dental	4524cb96-40f7-471f-bfc6-1dcab47628ec	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020971 application number: NDA020971

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QS9014Q792	ARTICAINE HYDROCHLORIDE	23964-57-0	ARTICAINE HYDROCHLORIDE
30Q7KI53AK	EPINEPHRINE BITARTRATE	51-42-3	EPINEPHRINE BITARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1595035	articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.7 mL Dental Cartridge	PSN	d9402ac2-fedd-4fb0-90a3-2c466a786526	11
1595029	articaine HCl 4 % / EPINEPHrine 1:200,000 in 1.7 mL Dental Cartridge	PSN	d9402ac2-fedd-4fb0-90a3-2c466a786526	11
1595029	1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.005 MG/ML Cartridge	SCD	d9402ac2-fedd-4fb0-90a3-2c466a786526	11
1595035	1.7 ML articaine hydrochloride 40 MG/ML / epinephrine 0.01 MG/ML Cartridge	SCD	d9402ac2-fedd-4fb0-90a3-2c466a786526	11
1595035	articaine HCl 4 % / epinephrine 1:100,000 (as epinephrine bitartrate 0.018 MG/ML) 1.7ML Dental Cartridge	SY	d9402ac2-fedd-4fb0-90a3-2c466a786526	11
1595035	articaine HCl 4 % / epinephrine 1:100,000 1.7 ML Dental Cartridge	SY	d9402ac2-fedd-4fb0-90a3-2c466a786526	11
1595029	articaine HCl 4 % / epinephrine 1:200,000 1.7 ML Cartridge	SY	d9402ac2-fedd-4fb0-90a3-2c466a786526	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-6620-05	00404662005	50 CARTRIDGE in 1 CARTON (0404-6620-05) / 1.7 mL in 1 CARTRIDGE	50 cartridge	2015-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Articaine Hydrochloride and Epinephrine	Henry Schein \| Novocol Pharmaceutical of Canada, Inc.	2024-03-01	HUMAN PRESCRIPTION DRUG LABEL	11
Articaine Hydrochloride and Epinephrine	Henry Schein \| Novocol Pharmaceutical of Canada, Inc.	2016-12-08	HUMAN PRESCRIPTION DRUG LABEL	1