Application 018543

Type: NDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1GM/VIAL	No	No
002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2GM/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N018543-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982
N018543-002	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION		Approved before 1982

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018543-001	LIDOCAINE HYDROCHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018543-002	LIDOCAINE HYDROCHLORIDE	2GM/VIAL	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`

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 8 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MediFirst Burn	LIDOCAINE HYDROCHLORIDE	Unifirst First Aid Corporation	9fa5b348-29c2-4cd0-a945-0486bd27f5e0	2025-09-08	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Unifirst First Aid Corporation	4c2e2b91-d2f6-4e41-9a4c-ecabca9830e8	2025-09-08	Warnings	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
HealthWise 4% Lidocaine Cream 2.7 oz	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	f39eb3d0-e153-4f50-85b1-ad5c677d176c	2025-08-28	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Cintas First Aid & Safety	96f17095-31f3-4b8a-ab22-0caaefaa7476	2025-08-15	Warnings	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Aruba Aloe Alcoholada	LIDOCAINE HYDROCHLORIDE	Aruba Aloe Balm NV	f56c62b0-75db-4499-858e-54e10b0e140a	2025-08-07	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Lannett Company, Inc.	c3353e08-2a8c-4ace-ba89-114f7131b8de	2025-08-07	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Aurobindo Pharma Limited	ab461805-413a-4fb3-88a1-224e1c423084	2025-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On	LIDOCAINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4	2025-07-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	845b96c1-36a3-431f-8316-112ae881d934	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	767374af-89d1-4c19-bd8e-480699b45cf7	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE
Burn	LIDOCAINE HYDROCHLORIDE	J&A Digital Inc.	d4b09055-b93e-466f-9e24-cae098af6e24	2025-06-02	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	25370b0f-0ac6-4a03-abe6-d73d65192180	2025-05-31	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	75d17334-6876-42d0-8a02-82669d139e4f	2025-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Huons Co., Ltd.	8ec2d256-fc4f-44f6-bee2-eef2bf3bf580	2025-05-09	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	5523fdfe-69fd-49a5-b51f-73e2223d49a9	2025-05-01	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	4dd52202-8eef-4136-92dd-ada573b7cf74	2025-04-22	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Xttrium Laboratories, Inc.	31a5a48e-27d7-90f3-e063-6294a90a2d9e	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	cddb2b22-fce3-8967-6e54-dca3df5ac4b3	2025-03-26	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	abf60c5c-66df-4894-aa8f-bf770a6e9d00	2025-03-24	Warnings, Adverse reactions	Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	037764d3-da0e-5ebb-e063-6294a90ab6e0	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.