Application 013077

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XYLOCAINE	LIDOCAINE	SUPPOSITORY;RECTAL	100MG	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
N013077-001	XYLOCAINE	LIDOCAINE	100MG	SUPPOSITORY / RECTAL		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	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N013077-001	XYLOCAINE	100MG	SUPPOSITORY / RECTAL	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 13 of 26 · 502 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BONDLIDO	LIDOCAINE	MEDRx USA, Inc.	17e69028-d2c2-4080-8090-cb0cab570196	2025-10-06	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
DYNAMO DELAY	LIDOCAINE	Momentum Management LLC	2ad63160-4f6f-4970-80b6-f6d19c5660a5	2025-10-03	Warnings	Name fallback generic name: LIDOCAINE
PROSTAT FIRST AID Burn Ease, 0.9g	LIDOCAINE	ProStat First Aid LLC	dc704403-e2aa-47f7-a7f4-f6afe1547ca8	2025-10-01	Warnings	Name fallback generic name: LIDOCAINE
PROSTAT FIRST AID Burn Ease, 0.9g	LIDOCAINE	ProStat First Aid LLC	e02558a9-fe2b-4f28-9fd3-7308f859d759	2025-10-01	Warnings	Name fallback generic name: LIDOCAINE
FL Burn Ease, 0.9g	LIDOCAINE	ProStat First Aid LLC	4dc0d579-ab42-4ea5-9788-5e54d7d318a3	2025-10-01	Warnings	Name fallback generic name: LIDOCAINE
Tylenol Precise Pain Relieving Lidocaine 4%	LIDOCAINE	Kenvue Brands LLC	36a95afd-97e5-2271-e063-6394a90aea18	2025-09-30	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	PHOENIX RX LLC	3ff29d56-8f20-6376-e063-6294a90a667b	2025-09-29	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	3ffc57c7-5bf4-cba8-e063-6394a90a322f	2025-09-29	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Hydrochloride	LIDOCAINE	Henry Schein, Inc.	0c0790ec-effd-4d8a-9874-8ca0b31e54d0	2025-09-29	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	2310b6ae-cacf-4b29-9b03-7f42849dfc18	2025-09-22	Warnings	Name fallback generic name: LIDOCAINE
Asper Flex	LIDOCAINE	Akron Pharma Inc.	06ddae64-cda7-4eb9-872f-5182c83cb00c	2025-09-19	Warnings	Name fallback generic name: LIDOCAINE
Good Neighbor Pain Relief Patch With Lidocaine 4%	LIDOCAINE	Amerisource Bergen	5f5cc887-d479-4c9a-affc-49d0c331f742	2025-09-18	Warnings	Name fallback generic name: LIDOCAINE
Burn Ease Cooling	LIDOCAINE	ProStat First Aid LLC	ec201ca1-efa0-4797-aec3-115647c29abd	2025-09-17	Warnings	Name fallback generic name: LIDOCAINE
JO for Him Prolonger with Lidocaine	LIDOCAINE	CC Wellness LLC	b12dc6a3-142d-3219-e053-2995a90aead0	2025-09-12	Warnings	Name fallback generic name: LIDOCAINE
PAIN RELIEF PATCHES	LIDOCAINE	Amerisource Bergen	614f1e56-891f-4620-be10-0c075a1dbc3f	2025-09-11	Warnings	Name fallback generic name: LIDOCAINE
Bikini Zone Medicated Creme	LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	300ac57e-844a-4840-b285-41ff5518e6b6	2025-08-29	Warnings	Name fallback generic name: LIDOCAINE
Bikini Zone Medicated Gel	LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	30b85890-e72d-4af7-bda9-e7744abc92af	2025-08-29	Warnings	Name fallback generic name: LIDOCAINE
Sumifun Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3d7dc8cc-0680-d94d-e063-6394a90ac8e8	2025-08-29	Warnings	Name fallback generic name: LIDOCAINE
else.	LIDOCAINE	Else Co.	3d6c7b10-ed03-bbde-e063-6294a90ae92f	2025-08-28	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Actavis Pharma, Inc.	c18799cd-9e11-4196-9ab1-0a2a84585e56	2025-08-26	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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