Application 008816

Type: NDA
Sponsor: OAK PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	JELLY;TOPICAL	2%	Yes	Yes

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
N008816-001	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982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	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL		RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL		RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL		RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008816-001	XYLOCAINE	2%	JELLY / TOPICAL	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N008816-001	AT	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N008816-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008816-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008816-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008816-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008816-001	AT	1	`ea99ee380514…`

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 16 · 315 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XYLOCAINE	XYLOCAINE	HF Acquisition Co LLC, DBA HealthFirst	0c6c5678-e987-b822-e063-6394a90ac88b	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: XYLOCAINE
Burn	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	eca272cb-ac8f-982b-e053-2995a90aa8b2	2024-01-15	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Caring mill Lidocaine Aloe Gel Burn and Pain Relief	LIDOCAINE HYDROCHLORIDE	FSA Store Inc.	0ec20c87-1681-dd23-e063-6394a90a291c	2024-01-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	09c10cd0-b634-ab9d-e063-6294a90aa544	2024-01-09	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Theraworx Pain Relief Roll-On with Lidocaine for Diabetics	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29	2024-01-08	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic	LIDOCAINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	bf954949-a7b7-44ba-8565-f1d5c0a6c0d1	2023-12-21	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c5d27da0-e495-4bb6-a7e1-8eaa6595eb71	2023-12-14	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	A-S Medication Solutions	38610ee9-4e70-4a8a-a5c5-6c148cf145f0	2023-12-04	Warnings, Adverse reactions	Name fallback brand name: Xylocaine
Thera Plus Max Strength Lidocaine Pain Relief Liquid	LIDOCAINE HYDROCHLORIDE	Fourstar Group USA, Inc.	0a228b06-0e1c-6c75-e063-6294a90a9a0e	2023-11-30	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	Southern Sales & Service, Inc.	9089cb78-e9f8-4437-a767-df809a114c4b	2023-11-29	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	0a353fe1-b779-3d1f-e063-6294a90ab21b	2023-11-15	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
MAXOCAINE Lidocaine Hemp Oil Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Prime Commerce, LLC	28ed2149-38d2-4062-8442-990a98a69cfc	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
SUGAR BRANDS Rescue Pain Relief and Recovery	LIDOCAINE HYDROCHLORIDE	Sugar Brands, LLC	74013709-d1d5-4425-825d-eee726718c61	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
NATURES CRAFT LIDOCAINE Male Genital Desensitizer	LIDOCAINE HYDROCHLORIDE	Natures Design Products LLC	61bf1776-5c6c-4307-8348-41fa60164017	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
KARMA RUB Elemental Pain Relief	LIDOCAINE HYDROCHLORIDE	Elemental Bliss LLC	c224fb1b-827f-461e-a58f-4020700c3e0d	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
INTIMALE Maximum Strength Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	25b9ade3-72b0-4b86-8c48-90310a26806f	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
POWERECT Max Power Male Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	25a1c926-9543-44a7-865e-a4b6e1a40cbe	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
SKINS DELAY Maximum Strength Lidocaine	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	172efe5d-28b8-443c-b3f9-429669189081	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
LIDOSOLVE PAIN RELIEF	LIDOCAINE HYDROCHLORIDE	HENNIKA HEALTH, LLC	3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2	2023-11-11	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	65a319a6-89d2-44c9-81d5-30327f9948cb	2023-11-10	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76478-479	Xylocaine	Lidocaine Hydrochloride	Oak Pharmaceuticals, Inc.	NDA	Current
76478-479	Xylocaine	Lidocaine Hydrochloride	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current
76478-479	Xylocaine	Lidocaine Hydrochloride	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81867	SUPPL	2025-04-08
81813	SUPPL	2025-04-02
56310	SUPPL	2018-11-06
56256	SUPPL	2018-11-02
10713	SUPPL	2004-07-28
116	SUPPL	2004-07-28