Application 018967

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	200MG/100ML	No	No
002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	400MG/100ML	No	No
003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	800MG/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	200MG/100ML	INJECTABLE / INJECTION	1984-03-30
N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	400MG/100ML	INJECTABLE / INJECTION	1984-03-30
N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	800MG/100ML	INJECTABLE / INJECTION	1984-03-30

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018967-002	LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1984-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018967-003	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1984-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018967-001	LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1984-03-30	`79d66fd596c7…`

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 15 · 299 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Lifestar Pharma LLC	9cb98fb0-5204-4973-8be7-f44ddbfde2ab	2024-09-03	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Wildman Business Group	1fd1a4b3-b6fd-0d4c-e063-6394a90a3680	2024-09-01	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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