Application 014127

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XYLOCAINE	LIDOCAINE	SOLUTION;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
N014127-001	XYLOCAINE	LIDOCAINE	5%	SOLUTION / 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	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N014127-001	XYLOCAINE	5%	SOLUTION / TOPICAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N014127-001	XYLOCAINE	5%	SOLUTION / 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 7 of 26 · 502 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Sportpharm LLC	74bad838-2800-4d36-a3ee-cc1d739d24c2	2026-03-21	Warnings, Adverse reactions	Name fallback brand name: Xylocaine
LIDOCAINE	LIDOCAINE	DIRECT RX	a575bcb8-478f-1f7e-e053-2995a90a4b12	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Direct_Rx	00725e5b-694c-b9e1-e063-6294a90a4182	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Direct_rx	29f211ff-dcba-afb0-e063-6294a90afb9b	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Crane Safety Burn	LIDOCAINE	Crane Safety LLC	96d81566-6321-731e-e053-2995a90ad07d	2026-03-16	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	DIRECT RX	b8663046-67a4-4858-e053-2a95a90a8aed	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	e0bfe16f-7a3f-48e0-a2e6-2ec68159a888	2026-03-14	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
lidocaine	LIDOCAINE	A-S Medication Solutions	967b0c5d-679d-4b69-9d6a-bc322baf6e04	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine Cream, 4%	LIDOCAINE	IPG PHARMACEUTICALS, INC.	7775bfdd-7eac-4f09-b83f-fc4a16a24558	2026-03-10	Warnings	Name fallback generic name: LIDOCAINE
Careland Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	7de99b81-b3b3-49f1-8aa7-2ff42e1b46a4	2026-03-09	Warnings	Name fallback generic name: LIDOCAINE
Welmate Lidocaine Pain Relieving Patch	LIDOCAINE	YYBA Corp	cff71b75-fc4e-29ac-e053-2995a90abd50	2026-03-06	Warnings	Name fallback generic name: LIDOCAINE
Careland Pain Relief Patch Plus	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e3	2026-03-04	Warnings	Name fallback generic name: LIDOCAINE
Numb Fast Hemorrhoidal	LIDOCAINE	Oasis Plus LLC	a00ffed7-8034-4cc0-87c4-3c793c1bcd6e	2026-03-03	Warnings	Name fallback generic name: LIDOCAINE
Equate Hemorrhoid Relief	LIDOCAINE	Walmart Inc.	48646860-ed5d-62a0-e063-6394a90abb23	2026-03-01	Warnings	Name fallback generic name: LIDOCAINE
NUMBING CREAMS	LIDOCAINE	Yongchun Lihui Trading Co., Ltd.	3b5e1a74-5946-4f1f-e063-6394a90a404b	2026-02-27	Warnings	Name fallback generic name: LIDOCAINE
Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy	LIDOCAINE	InterMed Laboratories Private Limited	4bade8a9-43bd-b649-e063-6294a90a81da	2026-02-25	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Sportpharm LLC	1112681c-8de7-472b-8db4-2702054b835b	2026-02-23	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Sportpharm LLC	4611f0da-a41d-4861-9dd6-f16f1b007d33	2026-02-23	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Veiurkiu External Analgesic Cream	LIDOCAINE	BLOOMWELL GARDENS LLC	40ec5e6f-13dc-de04-e063-6294a90af5d5	2026-02-18	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	A-S Medication Solutions	82bb7767-5407-4593-b6d4-90859890e376	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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