Lidocaine

Product NDC: 0362-0898
Requested package NDC: 0362-0898-05
11-digit product format: 003620898
Labeler code: 0362
Product ID: 0362-0898_addef151-af97-4dca-8652-e835e89a19a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride and Epinephrine
Dosage form: INJECTION, SOLUTION
Route: SUBMUCOSAL
Labeler: Septodont, Inc.
Application: ANDA088390
Marketing category: ANDA
Marketing start: 2018-07-18
Substance: EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
Active strength: .01; 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 1.

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
A088390-001	LIGNOSPAN STANDARD	EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE	EQ 0.01MG 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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RS	1985-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088390-001	LIGNOSPAN STANDARD	EQ 0.01MG BASE/ML;2%	INJECTABLE / INJECTION	RLD, RS	1985-01-22	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Benco Dental	c5cc87df-df3f-42b8-af84-5f2045d42084	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
LIDOCAINE	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Patterson Dental	6506755f-c9f7-4286-9ba7-ac5d5745f5e4	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Darby Dental Supply, LLC	e5ed4c2a-e320-48cf-a2fd-61d48481c624	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Henry Schein Inc.	f8d90500-f797-4238-8dd2-b59cbcd89d12	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Novocol Pharmaceutical of Canada, Inc.	2005680a-8a23-4403-a618-e4ee74fa1121	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lignospan Standard	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	f902d2b4-28fc-41b1-a9f7-0d1a63c598aa	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Safco Dental Supply Co	6721c3ab-c37f-4504-aebc-0103c56ed567	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
LIDOCAINE	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	NDC, Inc.	937e9341-e604-4ca7-98e1-fc7c659d82e9	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	The Atlanta Dental Supply Company DBA Advanced Dental Products	55030c51-250b-4fc2-ba3c-ac38dab7cc8e	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	864e511b-cc50-4ed9-b122-8e1a93457332	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390 ndc (package): 0362-0898-05 ndc (product): 0362-0898 ndc11 (package): 00362089805
Xylocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Dentsply Pharmaceutical	14b55cf9-f7cd-4bb4-a7c5-aba61abadef1	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088390 application number: ANDA088390

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	.01 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1293648	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
864e511b-cc50-4ed9-b122-8e1a93457332	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
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
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
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
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0362-0898-05	Lidocaine	50 in 1 CARTON	INJECTION, SOLUTION	50		4
0362-0898-05	Lidocaine	1.7 mL in 1 CARTRIDGE	INJECTION, SOLUTION	1.7		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0362-0898-05	ML - Milliliter	0362-0898	b03d0f2a-7501-46da-8f5c-13bdf5671553	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0362-0898	LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [SEPTODONT, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240209_864e511b-cc50-4ed9-b122-8e1a93457332.zip

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
1293648	lidocaine HCl 2 % / EPINEPHrine 1:100,000 in 1.7 mL Dental Cartridge	PSN	864e511b-cc50-4ed9-b122-8e1a93457332	4
1293648	1.7 ML epinephrine 0.01 MG/ML / lidocaine hydrochloride 20 MG/ML Cartridge	SCD	864e511b-cc50-4ed9-b122-8e1a93457332	4
1293648	lidocaine HCl 2 % / epinephrine 1:100,000 1.7 ML Dental Cartridge	SY	864e511b-cc50-4ed9-b122-8e1a93457332	4
1293648	lidocaine HCl 2 % with epinephrine 1:100,000 1.7 ML Dental Cartridge	SY	864e511b-cc50-4ed9-b122-8e1a93457332	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0362-0898-05	00362089805	50 CARTRIDGE in 1 CARTON (0362-0898-05) / 1.7 mL in 1 CARTRIDGE	50 cartridge	2018-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine	Septodont, Inc. \| Novocol Pharmaceutical of Canada, Inc.	2024-02-08	HUMAN PRESCRIPTION DRUG LABEL	4