Application 086389

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	SOLUTION;ORAL	2%	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
A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1982-02-02

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086389-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	1982-02-02	`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 10 of 16 · 302 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XYLOCAINE MPF	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	199ac3eb-1fa5-9cf5-e063-6394a90a7228	2024-11-15	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Meijer Pain Relieving Max Strength with Lavender Essential Oil Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	e688967e-799a-4fc8-a19a-f0012b90e76b	2024-11-15	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Acme United Corporation	f1f051ad-7e82-9d1a-e053-2a95a90ac7d3	2024-11-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
STING MASTER	LIDOCAINE HYDROCHLORIDE	Les Technologies Ptero, Inc	94c6fd1f-9e74-420b-9d25-61b37953b838	2024-11-05	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Alocane Emergency Burn	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	2024-11-05	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Alocane Botanicals	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	02a8e5c7-56f4-eb0d-e063-6294a90a80cd	2024-11-05	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Alocane Emergency Burn Pads	LIDOCAINE HYDROCHLORIDE	Quest Products, Inc.	fe58bb89-7216-4121-afd3-d1438bdfbfa2	2024-11-05	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
TopCare Pain Relieving Analgesic	LIDOCAINE HYDROCHLORIDE	Topco Associates LLC	6b4783e0-1987-4838-9e8c-b95426d62b28	2024-11-05	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Walgreens Pain Relieving with Lavender Analgesic	LIDOCAINE HYDROCHLORIDE	Walgreen Company	6c7b39c8-5b65-430a-a529-5b6b14adce18	2024-10-31	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Walgreens Pain Relieving with Turmeric Analgesic	LIDOCAINE HYDROCHLORIDE	Walgreen Company	317ec4fb-cff0-461d-9ca0-299527a3686d	2024-10-30	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Fruit of the Earth Cool Blue Aloe Mist Continuous	LIDOCAINE HYDROCHLORIDE	Fruit Of The Earth, Inc.	d4caae4c-efba-2453-e053-2995a90a5e5f	2024-10-18	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesic	LIDOCAINE HYDROCHLORIDE	WEGMANS FOOD MARKETS INC	f70bc438-7ed8-f74d-e053-6394a90a2b3f	2024-10-16	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
TopCare Everyday After Sun Cooling	LIDOCAINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	baff7293-e1a3-d1f2-e053-2995a90a93ca	2024-10-15	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Walgreens Cooling	LIDOCAINE HYDROCHLORIDE	WALGREEN COMPANY	baffb272-436c-4ad8-e053-2a95a90a56fb	2024-10-14	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Walgreens Sunburn Relief	LIDOCAINE HYDROCHLORIDE	WALGREEN COMPANY	d4c9913d-fcac-4785-e053-2995a90a7917	2024-10-14	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
SYREN Intimate Relief	LIDOCAINE HYDROCHLORIDE	Icon Health Science	57d5a080-3583-4510-e053-2a91aa0ad589	2024-09-25	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Theraworx PM Nighttime Maximum Strength Pain Relief	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	bc8cb476-9a47-47b3-ad78-a6ecec9ee66f	2024-09-19	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Eugia US LLC	ef782e5e-e2d7-465a-99c6-b12611f3158c	2024-09-12	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Meijer Analgesic Lidocaine Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa	2024-09-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Accucaine	LIDOCAINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	01679d29-a592-8cbb-e063-6394a90ad82a	2024-09-11	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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