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N008816-001	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982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N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`84e616aacf4f…`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N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`caaa826d4ba7…`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UTC	2026-02	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`011fe1cb6892…`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of this ZIP	2025-12	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`31067a03dcf5…`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UTC	2025-08	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`6a471c1ec25d…`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 14 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Uber Numb Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	UberScientific, LLC	4939a547-c94b-3350-e054-00144ff88e88	2023-11-10	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
DOCTORS TOUCH Erase The Pain Lidocaine	LIDOCAINE HYDROCHLORIDE	DOCTOR'S CHOICE MEDICAL, LLC	3dc9947b-8196-4a38-97b4-c2340ee77e0f	2023-11-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
RadiaGuard Advanced Radiation Relief	LIDOCAINE HYDROCHLORIDE	SMOOTH SIDE, INC	21205087-5a2e-41a5-be40-30cba2895408	2023-11-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
SKINS DELAY Climax Control Lidocaine	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	0db91010-12f7-4f20-b96c-432915720d5a	2023-11-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
POWERECT Lidocaine Male Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	42e0c40f-1efd-45ef-815d-53d193d720eb	2023-11-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
WAXUP Numbing	LIDOCAINE HYDROCHLORIDE	CONSTRUSOLUTION, LLC	4f1645ab-1b19-4d69-99c3-9ea275b01a87	2023-11-06	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
SCLERA CARE Topical Anesthetic Gel	LIDOCAINE HYDROCHLORIDE	ScleraCare, LLC	488ace02-fc0b-4d13-ab89-0e1640e915e5	2023-11-05	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Viscous	LIDOCAINE HYDROCHLORIDE	A-S Medication Solutions	75f2d450-aa2e-4a09-b4f7-4fcbcbf8b205	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Assured	LIDOCAINE HYDROCHLORIDE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	2023-10-25	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Theraworx Pain Relief Roll- On- Lidocaine	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	b4ce3876-f9e3-43ca-810b-75fbe6f887b6	2023-10-23	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
ADVANCED NUMB Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	Uber Scientific, LLC	859d1cad-badf-4c42-9b08-daacb3fae8b4	2023-10-13	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Bryant Ranch Prepack	ed43f2c3-606c-4998-8fca-ee9b13cd18db	2023-09-26	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Accucaine	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	584642a8-9bed-4d86-bfaf-99018c180e34	2023-08-09	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bcdbee5-014e-6b4c-e053-2a91aa0aecd2	2023-05-30	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	8968c61e-2686-0fe6-e053-2a95a90a15fa	2023-05-23	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	858f3faa-e56e-51f9-e053-2a91aa0aa721	2023-05-23	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6bdd64a8-b90e-57d4-e053-2a91aa0a3911	2023-05-22	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6947af02-f4e0-7f9c-e053-2a91aa0a45cd	2023-05-22	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86083fea-c064-4ef7-e053-2a91aa0ac17c	2023-05-16	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	86093c75-6dde-bb16-e053-2991aa0ab6ef	2023-05-16	Warnings, Adverse reactions	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