Lignospan Forte

Product NDC: 0362-1096
Requested package NDC: 0362-1096-70
11-digit product format: 003621096
Labeler code: 0362
Product ID: 0362-1096_cb2397ba-49a9-4c95-bbde-17d1260607ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride and Epinephrine
Dosage form: INJECTION, SOLUTION
Route: SUBMUCOSAL
Labeler: Septodont, Inc.
Application: ANDA088389
Marketing category: ANDA
Marketing start: 2017-12-01
Substance: EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
Active strength: .02; 20 mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088389-001	LIGNOSPAN FORTE	EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION		RLD, RS	1985-01-22

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088389-001	LIGNOSPAN FORTE	EQ 0.02MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lignospan Forte
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	.02 mg/mL
EPINEPHRINE BITARTRATE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	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
1011814	Internal RxNorm lookup
1657026	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
f8ca7d03-01c8-450f-9279-59789c3497ea	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
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
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
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0362-1096-70	Lignospan Forte	10 in 1 BLISTER PACK	INJECTION, SOLUTION	10		7
0362-1096-70	Lignospan Forte	5 in 1 CARTON	INJECTION, SOLUTION	5		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0362-1096	LIGNOSPAN FORTE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [SEPTODONT, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20240206_f8ca7d03-01c8-450f-9279-59789c3497ea.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Dentsply Pharmaceutical	14b55cf9-f7cd-4bb4-a7c5-aba61abadef1	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	df130310-41db-45df-a214-9da01cf0bf41	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Benco Dental	9419ac39-9b26-4cca-a2d6-167205fede24	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Darby Dental Supply, LLC	27e8fdfb-e923-4f99-aff7-8b9e50228151	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Patterson Dental	f074c0dc-7c3f-46fd-a480-b8337a19fe5c	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389
LIDOCAINE	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Henry Schein Inc.	1ca96c77-d983-496b-84a6-54709e80f532	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389
Lignospan Forte	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	f8ca7d03-01c8-450f-9279-59789c3497ea	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088389 application number: ANDA088389 ndc (package): 0362-1096-70 ndc (product): 0362-1096 ndc11 (package): 00362109670

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
30Q7KI53AK	EPINEPHRINE BITARTRATE	51-42-3	EPINEPHRINE BITARTRATE
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1657026	lidocaine HCl 2 % with EPINEPHrine 1:50,000 in 1.7 ML Dental Cartridge	PSN	f8ca7d03-01c8-450f-9279-59789c3497ea	7
1011814	Lignospan forte 2 % / 1:50,000 in 1.7 mL Dental Cartridge	PSN	f8ca7d03-01c8-450f-9279-59789c3497ea	7
1011814	1.7 ML epinephrine 0.02 MG/ML / lidocaine hydrochloride 20 MG/ML Cartridge [Lignospan]	SBD	f8ca7d03-01c8-450f-9279-59789c3497ea	7
1657026	1.7 ML epinephrine 0.02 MG/ML / lidocaine hydrochloride 20 MG/ML Cartridge	SCD	f8ca7d03-01c8-450f-9279-59789c3497ea	7
1657026	epinephrine 1:50,000 / lidocaine HCl 2 % 1.7 ML Cartridge	SY	f8ca7d03-01c8-450f-9279-59789c3497ea	7
1657026	lidocaine HCl 2 % with epinephrine 1:50,000 1.7 ML Dental Cartridge	SY	f8ca7d03-01c8-450f-9279-59789c3497ea	7
1011814	Lignospan forte 2 % / 1:50,000 1.7 ML Dental Cartridge	SY	f8ca7d03-01c8-450f-9279-59789c3497ea	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0362-1096-70	00362109670	5 BLISTER PACK in 1 CARTON (0362-1096-70) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE	5 blister pack	2017-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lignospan Forte	Septodont, Inc. \| Novocol Pharmaceutical of Canada, Inc.	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	7