Zorcaine

Product NDC: 31382-830
11-digit product format: 313820830
Labeler code: 31382
Product ID: 31382-830_92cc5ca7-1aaf-4912-802c-80837ddd6e3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Articaine hydrochloride and Epinephrine Bitartrate
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Carestream Health, Inc.
Application: NDA020971
Marketing category: NDA
Marketing start: 2011-09-01
Marketing end: 0000-00-00
Substance: ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength: 40 mg/mL; mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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	31382-830		D	Discontinued by firm		2026-08-03
excluded package	package	31382-830	31382-830-50	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 · 38 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	31382-830-50	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	31382-830-50	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	31382-830-50	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	31382-830-50	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	31382-830-50	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	31382-830-50	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	31382-830-50	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	31382-830-50	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	31382-830-50	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	31382-830-50	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	31382-830-50	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	31382-830-50	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	31382-830-50	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	31382-830-50	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	31382-830-50	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	31382-830-50	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
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	31382-830-50	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	31382-830-50	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	31382-830-50	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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
31382-830-50	2023-02-07	C162847	48780-1	9d75b9d0-9bf5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Zorcaine ™ safely and effectively. See full prescribing information for Zorcaine™. Initial U.S. Approval: 2000 Zorcaine™ (articaine HCl and epinephrine) Injection; Intraoral Submucosal Injection Articaine hydrochloride 4% and epinephrine 1:100,000 Articaine hydrochloride 4% and epinephrine 1:200,000
31382-830-50	2020-01-31	C162847	48780-1	9d75b9d0-9bf5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Zorcaine ™ safely and effectively. See full prescribing information for Zorcaine™. Initial U.S. Approval: 2000 Zorcaine™ (articaine HCl and epinephrine) Injection; Intraoral Submucosal Injection Articaine hydrochloride 4% and epinephrine 1:100,000 Articaine hydrochloride 4% and epinephrine 1:200,000

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Articaine hydrochloride	ACTIVE INGREDIENT	QS9014Q792	ZORCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH, INC.]	1
Epinephrine Bitartrate	ACTIVE INGREDIENT	30Q7KI53AK	ZORCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH, INC.]	1
Articaine	ACTIVE MOIETY	D3SQ406G9X	ZORCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH, INC.]	1
Epinephrine	ACTIVE MOIETY	YKH834O4BH	ZORCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH, INC.]	1
Sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ZORCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH, INC.]	1
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ZORCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH, INC.]	1
Sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	ZORCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	ZORCAINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [CARESTREAM HEALTH, 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 · 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
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zorcaine	Carestream Health, Inc. \| Novocol Pharmaceutical of Canada, Inc.	2017-12-27	HUMAN PRESCRIPTION DRUG LABEL	2