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N008816-001	XYLOCAINE	LIDOCAINE HYDROCHLORIDE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982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N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`84e616aacf4f…`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N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`caaa826d4ba7…`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UTC	2026-02	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`011fe1cb6892…`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of this ZIP	2025-12	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`31067a03dcf5…`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UTC	2025-08	N008816-001	XYLOCAINE	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	JELLY / TOPICAL		RLD, Approved before 1982	`6a471c1ec25d…`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 15 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	79798b21-026d-1b4c-e053-2a91aa0a0129	2023-05-16	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	89691444-7bfb-3314-e053-2a95a90a268e	2023-05-15	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9c9655fd-89a9-77c8-e053-2a95a90a0c99	2023-05-15	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e412b4c-e24f-69ea-e053-2995a90ac600	2023-05-10	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e049bbe-0f4d-988e-e053-2a95a90a3691	2023-05-10	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	b63614eb-8776-4cd0-e053-2995a90a8f82	2023-05-04	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	c8e7f9ef-1982-b8ce-e053-2a95a90ac4ee	2023-04-27	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	c8e8b217-a183-0d91-e053-2a95a90a4a44	2023-04-25	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
PharmapureRx Lidocaine HCl 4.12%	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	b7a77ad1-821b-4388-a97c-aadb1340c536	2023-01-11	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	International Medication Systems, Limited	5d3e9984-cef9-46f2-a6c9-3be8b26f45b3	2022-12-29	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Bactine Max Dry	LIDOCAINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	466404cd-c46a-4944-b1ac-3b3b17f436a1	2022-12-27	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	B. Braun Medical Inc.	e0e479e6-4c94-44d0-8074-d0ee7b2bde22	2022-10-13	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	fecd1797-7757-4da8-b3a1-24b258634243	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	8ae0656c-36fb-48fb-886b-1031d11da552	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Asclemed USA, Inc.	deec52c7-ebcf-422e-beab-bc1df2fe30cb	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidotran	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	cf715e54-c413-1e8f-e053-2995a90a076d	2022-09-19	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Novitium Pharma LLC	ffb2d794-2c88-48a2-beff-d01b6fcea51f	2022-03-25	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lydexa 4.12%	LIDOCAINE HYDROCHLORIDE	PureTek Corporation	aa1c9d39-1283-8c6b-e053-2a95a90af5b5	2022-03-02	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	International Medication Systems, Limited	2c48cfac-81eb-4a81-8590-bc94574dd4c3	2021-12-14	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine	LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	ba082c2f-64f4-419d-9c88-74f203316e17	2021-08-25	Warnings, Adverse reactions	Name fallback brand name: Xylocaine 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