Application 020575

Type: NDA
Sponsor: NOVEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DENTIPATCH	LIDOCAINE	FILM, EXTENDED RELEASE;BUCCAL	23MG/PATCH	No	No
002	DENTIPATCH	LIDOCAINE	PATCH;TOPICAL	46.1MG/PATCH	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020575-001	DENTIPATCH	LIDOCAINE	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL			1996-05-21
N020575-002	DENTIPATCH	LIDOCAINE	46.1MG/PATCH	PATCH / TOPICAL			1996-05-21

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020575-001	DENTIPATCH	23MG/PATCH	FILM, EXTENDED RELEASE / BUCCAL	1996-05-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020575-002	DENTIPATCH	46.1MG/PATCH	PATCH / TOPICAL	1996-05-21	`74a2ff9319b5…`

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 17 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5% Signature Numb cream	LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	2f043d3c-d8db-414e-e063-6394a90a13de	2025-02-25	Warnings	Name fallback generic name: LIDOCAINE
Arthcal 4% Lidocaine Gel Patches	LIDOCAINE	Beijing JUNGE Technology Co., Ltd.	2e6278bb-ca55-70ff-e063-6294a90a6a58	2025-02-17	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	REMEDYREPACK INC.	94ab1b99-e203-4a14-b852-42d3b37999c3	2025-02-14	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	NuCare Pharmaceuticals, Inc.	2e0f4ca3-874a-f0d0-e063-6294a90a0b65	2025-02-13	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Signature Care Medicated Pain Relief Patch	LIDOCAINE	Safeway, Inc.	2165a342-5f8b-78e0-e063-6394a90a06c4	2025-02-12	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	Alembic Pharmaceuticals Limited	071b2cfd-07ad-46a3-8808-87080d545fd3	2025-02-11	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
AsperFlex	LIDOCAINE	Akron Pharma Inc.	ab50525e-b534-452b-8c25-2992c0cbf862	2025-02-10	Warnings	Name fallback generic name: LIDOCAINE
Lidocore	LIDOCAINE	iON Pharma, LLC	204c3e50-1ac8-f442-e063-6294a90ae7b5	2025-02-05	Warnings	Name fallback generic name: LIDOCAINE
lidocaine	LIDOCAINE	Nivagen Pharmaceuticals, Inc.	32964ec3-1880-477b-9f71-2222c39106aa	2025-01-23	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Direct_Rx	fd8a640a-b5ca-f0a7-e053-6394a90ad603	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Direct_Rx	feb8692a-9c08-0d5c-e053-6394a90a904b	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	PHARMACURE LLC	53384c51-6da1-4fa4-8782-2606ca3d1c6f	2025-01-22	Warnings	Name fallback generic name: LIDOCAINE
Care Science	LIDOCAINE	ASO LLC	2c399fec-bce7-2a41-e063-6294a90a0e73	2025-01-21	Warnings	Name fallback generic name: LIDOCAINE
RETALIEF LIDOCAINE 5	LIDOCAINE	Reliable 1 Laboratories LLC	2c262f3c-8cb2-4384-e063-6294a90a436d	2025-01-20	Warnings	Name fallback generic name: LIDOCAINE
Curist Lidocaine Patch Maximum Strength	LIDOCAINE	Little Pharma, Inc.	e574c188-cc65-287d-e053-2995a90a5972	2025-01-16	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	296fcc36-563f-19ca-e063-6394a90ab3ae	2025-01-15	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief Patch 4% Lidocaine	LIDOCAINE	Reliable 1 Laboratories LLC	2b624763-c310-63d9-e063-6394a90a1928	2025-01-15	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief 4% Lidocaine	LIDOCAINE	Unexo Life Sciences Private Limited	bfee9be1-b265-44bd-8e82-2ec27132f82b	2025-01-13	Warnings	Name fallback generic name: LIDOCAINE
Bactine Max	LIDOCAINE	WellSpring Pharmaceutical Corporation	acd7ae37-7c42-4ec7-a2ef-42e7f628388d	2025-01-08	Warnings	Name fallback generic name: LIDOCAINE
Salonpas LIDOCAINE Pain Relieving	LIDOCAINE	Hisamitsu Pharmaceutical Co., Inc.	4f3a438c-f378-4d2a-a95c-58e56cf1e797	2025-01-06	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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