Application 080210

Type: ANDA
Sponsor: BELMORA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE	LIDOCAINE	OINTMENT;TOPICAL	5%	No	No

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

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
A080210-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL		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 2 · 43 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	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080210-001	LIDOCAINE	5%	OINTMENT / TOPICAL	Approved before 1982	`f41ea6bd6efb…`

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 23 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Care Science	LIDOCAINE	ASO LLC	22cbb664-b659-3beb-e063-6394a90a9dab	2024-09-23	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Stratus Pharmaceuticals Inc	e1a8d4a7-01f7-4bab-8d09-875c461b3b61	2024-09-19	Warnings	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Aurobindo Pharma Limited	29199070-6dcb-4086-9a68-49e819965dbd	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Careland Max Strength Lidocaine 4 Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	265b8dd7-64a4-4bc2-a91c-26c761c2090b	2024-08-21	Warnings	Name fallback generic name: LIDOCAINE
Theracare Lidocaine Pain relief	LIDOCAINE	Veridian Healthcare	1d8a3679-637d-94c0-e063-6294a90a9ecf	2024-08-19	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	4e856dd5-f2fa-4acb-a205-f87baf26b8cc	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Bunnies Bum Hemorrhoidal Numbing	LIDOCAINE	FloCal Distributors LLC	1c809643-0cbe-568f-e063-6394a90a3210	2024-07-05	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	1b561cc6-1d36-e259-e063-6294a90aacbd	2024-06-27	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
PUREGEN LABS Pain Relief 4 Lidocaine	LIDOCAINE	Advanced Rx LLC	9dff40d8-8d7e-4629-bea5-987f5e68477d	2024-06-11	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	FORREAL PHARMACEUTICALS LLC	14edf7dc-c5dc-4b74-b583-0f87529f4536	2024-06-06	Warnings	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	1d28d687-695e-4cd9-97e2-7d4fdab9772a	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
PUREGEN LABS Maximum Strength Lidocaine	LIDOCAINE	Advanced Rx LLC	f4f89582-49e6-424a-bea7-0694484a7c99	2024-04-11	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	b4db5684-988f-44c4-a81e-5c04b8b0f6e7	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	19c585f3-e635-44d4-8eb0-14529eb34dca	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Meijer Pain Relief Cream	LIDOCAINE	Meijer Distribution	07ecee44-387a-cdce-e063-6294a90ab9c9	2024-03-27	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Safco Dental Supply Co	6721c3ab-c37f-4504-aebc-0103c56ed567	2024-02-08	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Leader Burn Relief	LIDOCAINE	Cardinal Health	f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2	2024-02-06	Warnings	Name fallback generic name: LIDOCAINE
Aspercreme	LIDOCAINE	Lead Chemical Co. Ltd.	275e1343-deef-424a-a883-5e780083af91	2024-01-25	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	65cf652c-87f2-43c6-a6f8-e4a83b42ce78	2024-01-24	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Burn	LIDOCAINE	HART Health	e95ebdac-9789-41c2-97da-2307e4538794	2024-01-18	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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