Application 021380

Type: NDA
Sponsor: DENTSPLY PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XYLOCAINE DENTAL	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	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
N021380-001	XYLOCAINE DENTAL	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		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	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021380-001	XYLOCAINE DENTAL	2%	INJECTABLE / INJECTION	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 3 of 16 · 302 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EVERLIT CARE PRODUCTS BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	5371dae4-ea63-46cc-ac26-5418f359c63e	2026-05-04	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
FIRSTAR BURN	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	186343c5-2e71-49c4-8d64-5fb3131239fa	2026-05-04	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	cffda6fc-7e85-4c48-9623-2551d3552d7d	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	7f202319-effa-4dd8-b871-e720b75f4a83	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Bryant Ranch Prepack	850bdb6a-85d9-441d-8666-7a61311386b6	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Sportpharm LLC	7adb9ab0-ef91-4c51-baa3-a0b7e12df077	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Bryant Ranch Prepack	8f79b023-9bd1-4bd6-8fd0-f9efe88abec0	2026-04-20	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	9a1418e2-b208-4e5c-b5f8-21b3a691a578	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
TATTOO NUMBX NUMBING PAIN RELIEVING	LIDOCAINE HYDROCHLORIDE	Scyberco Ltd	ac8eac04-ed5b-4c8e-9f9b-54d160b74606	2026-04-02	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochloride	LIDOCAINE HYDROCHLORIDE	REMEDYREPACK INC.	adc4dd69-45f3-48fe-bf85-f014b384c38e	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1	2026-04-01	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Burn Mist	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	c53ab9dd-351a-400b-b873-4f396e0af54d	2026-03-31	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving	LIDOCAINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	f7faddb2-5153-4fdd-a5ef-778182cef460	2026-03-31	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Keeps Climax Delay	LIDOCAINE HYDROCHLORIDE	Cosco International, Inc.	3bfd3173-2dac-40a9-aec3-982b1d47d8fa	2026-03-12	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
CVS Foot Pain	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4c3350c3-2e3e-093c-e063-6394a90a3475	2026-03-04	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Icy Hot Lidocaine No-Mess	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	347f9a18-8ab6-47d3-9610-5b4e9ca5d53a	2026-03-02	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Gold Bond Maximum Strength Foot Pain Relief	LIDOCAINE HYDROCHLORIDE	Gold Bond Co LLC	8e469076-2f5a-4de8-8d13-a38c072b9af8	2026-03-01	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
HealthWise Pain Relief Lidocaine	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	48ecbab9-13e0-d0fa-e063-6294a90a6ff2	2026-02-28	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
Pain Relieving Gel	LIDOCAINE HYDROCHLORIDE	Chain Drug Marketing Association	b55b7253-2fd2-45cc-b94c-e92395ab0d2b	2026-02-27	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE HYDROCHLORIDE
0.5% LIDOCAINE BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	cf723c7b-495d-4bae-942c-561cf28af2d3	2026-02-21	Warnings	Name fallback generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56332	SUPPL	2018-11-07
56267	SUPPL	2018-11-05