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 2 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE HYDROCHLORIDE	Sentiss Pharmaceuticals LLC	9b2d4f69-0c84-4956-b5c0-b4410acf62e0	2026-08-12	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	864e511b-cc50-4ed9-b122-8e1a93457332	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	The Atlanta Dental Supply Company DBA Advanced Dental Products	55030c51-250b-4fc2-ba3c-ac38dab7cc8e	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	df130310-41db-45df-a214-9da01cf0bf41	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing	LIDOCAINE	Putian Licheng District Zhijiancheng Trading Co., Ltd.	4a7be9eb-5e57-90e8-e063-6394a90aad9e	2026-08-08	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	NDC, Inc.	937e9341-e604-4ca7-98e1-fc7c659d82e9	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE
Dealmed Burn	LIDOCAINE	Dealmed Medical Supplies, LLC.	3b5f7ded-c275-4d7f-9fd4-539797d5507e	2026-08-05	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Plantar Relief Roll-On	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	585ccb4b-3bff-39b9-e063-6294a90a0e18	2026-08-05	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Numbing Cream	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	5457b3d7-e6b6-34a7-e063-6394a90aa240	2026-08-03	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	PHOENIX RX LLC	57edfcb8-272c-8af4-e063-6294a90ae2e5	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Benco Dental	c5cc87df-df3f-42b8-af84-5f2045d42084	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Benco Dental	9419ac39-9b26-4cca-a2d6-167205fede24	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
LIDOCAINE	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Patterson Dental	6506755f-c9f7-4286-9ba7-ac5d5745f5e4	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: LIDOCAINE
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Darby Dental Supply, LLC	27e8fdfb-e923-4f99-aff7-8b9e50228151	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Darby Dental Supply, LLC	e5ed4c2a-e320-48cf-a2fd-61d48481c624	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Patterson Dental	f074c0dc-7c3f-46fd-a480-b8337a19fe5c	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Lidocaine 4% Patch	LIDOCAINE	Aldermed Inc.	57994923-20fc-9d9d-e063-6394a90a22c9	2026-07-27	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine 4% Patch	LIDOCAINE	Aldermed Inc.	579a5012-837a-828b-e063-6294a90a4fb2	2026-07-27	Warnings	Name fallback generic name: LIDOCAINE
Lidfix Pain Relief Patch Lidocaine	LIDOCAINE	HETERO HEALTHCARE LIMITED	2149f0e3-1983-4f02-929e-ecd20357f4bb	2026-07-27	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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