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 20 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TheraCare Pain Relief Lidocaine	LIDOCAINE	Veridian Healthcare	cea6cdab-28a5-5bd0-e053-2a95a90a1295	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
Rite Aid Lidocaine Patch XLarge	LIDOCAINE	Rite Aid Corporation	efa531c2-4956-e93a-e053-2995a90ae0ea	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
Maximum Strength Pain Relief Lidocaine Patch	LIDOCAINE	Rite Aid Corporation	bd31105a-f73f-2f57-e053-2995a90a59c0	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
Meijer Lidocaine Pain Relief Patch Assortment Medium	LIDOCAINE	Meijer Distribution Inc	ab83b445-0e11-b985-e053-2995a90a0278	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
Meijer Lidocaine Pain Relief Patch Assortment Large	LIDOCAINE	Meijer Distribution Inc	aa7f9bc8-0d56-5dde-e053-2a95a90af0e7	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
Meijer Lidocaine Pain Relief Patch Assortment Small	LIDOCAINE	Meijer Distribution Inc	ab85ce5a-8787-4317-e053-2a95a90a62bc	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
MEIJER LIDOCAINE PAIN RELIEF BACK AND LARGE AREAS	LIDOCAINE	Meijer Distribution Inc	b9e512e3-8337-1f44-e053-2a95a90a7fcb	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
HealthWise Lidocaine Pain relief	LIDOCAINE	Veridian Healthcare	ce28a1d0-49f1-ed6f-e053-2a95a90a50db	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
MEIJER PAIN RELIEF PATCHES	LIDOCAINE	Meijer Distribution Inc	f591588e-467b-4c37-b0e1-c0be84422041	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
TheraCare Pain Relieving Patch with Lidocaine	LIDOCAINE	Veridian Healthcare	f93b00e1-06d6-9066-e053-6294a90ae89a	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
MEIJER PAIN RELIEF PATCHES	LIDOCAINE	Meijer Distribution Inc	aa5da66d-3ba9-4120-be35-44bec475761a	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
THERA CARE PAIN THERAPY	LIDOCAINE	Veridian Healthcare	e023bb5a-a4bc-4681-a1f4-48ca0d2cb102	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
Hunter Beach 4%	LIDOCAINE	HUNTERS BEACH LIFE	f2ef9c12-6e42-486b-b6f2-0ad534e94294	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
Hunter Beach 4%	LIDOCAINE	HUNTERS BEACH LIFE	05a9605b-0d01-4333-8e54-7202e7c31c49	2024-12-18	Warnings	Name fallback generic name: LIDOCAINE
RECTICARE	LIDOCAINE	Ferndale Laboratories, Inc.	49cb48cf-7a26-4d7a-887f-2e98261d269d	2024-12-17	Warnings	Name fallback generic name: LIDOCAINE
Albertsons Pain Relief Patch	LIDOCAINE	Safeway	dc2823bb-8586-daca-e053-2995a90a2af0	2024-12-17	Warnings	Name fallback generic name: LIDOCAINE
PAIN RELIEF PATCHES	LIDOCAINE	Walgreen Company	204b96bc-af4e-4842-8b57-7b416feb4dd9	2024-12-17	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Quality Care Products LLC	f20ab860-e49a-4f3f-868e-6a60780af5a7	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Lidocaine Dry	LIDOCAINE	CVS	bb7955fe-5113-1662-e053-2a95a90a85a1	2024-12-16	Warnings	Name fallback generic name: LIDOCAINE
Natural Seal Itch Relief for Kids	LIDOCAINE	Kericure Inc.	31cc0c95-5864-4737-b085-8f58e00f4f05	2024-12-12	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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