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 9 of 26 · 502 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relieving Patch	LIDOCAINE	FlexiGo Inc.	4868af2a-c4be-9c68-e063-6394a90a565b	2026-01-15	Warnings	Name fallback generic name: LIDOCAINE
Careland Lidocaine 4 Pain Relieving Gel-Patches	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	a6ca8382-7ce5-4df9-912e-8a0ac0423116	2026-01-15	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	AvKARE	0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Aspercreme with Lidocaine Essential Oils Rosemary Mint	LIDOCAINE	Chattem, Inc.	9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab	2026-01-13	Warnings	Name fallback generic name: LIDOCAINE
THE SOLUTION 2.0	LIDOCAINE	SCALP TECH INC	0fa423b6-cc0f-b569-e063-6294a90a239e	2026-01-09	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Bellus Medical, LLC	60cb89f6-e326-0773-e053-2a91aa0a33dd	2026-01-09	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE PAIN RELIEVING Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	2159fb73-cf6c-184a-e063-6394a90a1d14	2026-01-08	Warnings	Name fallback generic name: LIDOCAINE
Relieve A Pain	LIDOCAINE	Relieve A Pain LLC	cafaa830-d894-4590-8928-d579cc791d79	2026-01-08	Warnings	Name fallback generic name: LIDOCAINE
Dr. Care Numbing Cream	LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	47c94198-7718-bbc2-e063-6294a90a48f1	2026-01-07	Warnings	Name fallback generic name: LIDOCAINE
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots	LIDOCAINE	CVS PHARMACY, INC	caef51a8-76e9-42b3-a160-c54f62b47de1	2026-01-05	Warnings	Name fallback generic name: LIDOCAINE
TheraCare Lidocaine Pain Relief	LIDOCAINE	Veridian Healthcare	ee8cd550-64ee-432e-98e5-b68083179a3c	2026-01-05	Warnings	Name fallback generic name: LIDOCAINE
Steady Freddy	LIDOCAINE	Medical Symbiosis Pty Ltd	caa9eae9-7028-5185-e053-2a95a90ac504	2025-12-31	Warnings	Name fallback generic name: LIDOCAINE
HemRid Anorectal Cream	LIDOCAINE	KKA & Associates LLC	dbeb4325-3e85-1147-e053-2995a90a2160	2025-12-31	Warnings	Name fallback generic name: LIDOCAINE
Kroger Pain Relief Lidocaine Patch	LIDOCAINE	Kroger Company	f6407554-c9a7-24e2-e053-2a95a90aae02	2025-12-30	Warnings	Name fallback generic name: LIDOCAINE
PAIN RELIEF PATCHES	LIDOCAINE	Liberty Procurement, In	2d381c48-402f-4e46-81b2-41a184139a61	2025-12-30	Warnings	Name fallback generic name: LIDOCAINE
PAIN RELIEF PATCHES	LIDOCAINE	Harris Teeter	5a0501e8-bc06-4e33-8db8-93b21a715141	2025-12-29	Warnings	Name fallback generic name: LIDOCAINE
Honest Med Lidocaine Pain Relief Patch	LIDOCAINE	Proper Buys LLC	13a5243f-7116-e4da-e063-6394a90aa543	2025-12-28	Warnings	Name fallback generic name: LIDOCAINE
DISCOUNT DRUG MART PAIN RELIEF PATCHES	LIDOCAINE	Discount Drug Mart, Inc	e36e7d0a-d554-4601-b535-b41ee84a6b24	2025-12-28	Warnings	Name fallback generic name: LIDOCAINE
PAIN RELIEF PATCHES	LIDOCAINE	Ahold U.S.A., Inc,	7e7a813e-424d-4a78-9c72-541c3c62606a	2025-12-28	Warnings	Name fallback generic name: LIDOCAINE
Amazon Basics Pain Relief Patch with 4% Lidocaine	LIDOCAINE	Amazon.com Services LLC	e3b4f9b1-ac6b-cb2a-e053-2a95a90a9e1e	2025-12-28	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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