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 5 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Pain Relief Gel -Patch	LIDOCAINE	Guangzhou Sumi Technology Innovation Co., Ltd	514900f1-7fcb-636a-e063-6394a90a4ba2	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief Gel-Roll On	LIDOCAINE	Trifecta Pharmaceuticals USA	51cb6797-55ec-7a7a-e063-6294a90a90ee	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	412fd7c8-1e05-1779-e063-6294a90a3de4	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	433ac435-279e-574b-e063-6294a90a1d6d	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relief	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	3ef5bfac-0c05-b703-e063-6394a90a2276	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	3737cd00-0582-94e6-e063-6394a90a6280	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f1045448-ae78-eba6-e053-2a95a90a6793	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	fd0d4646-4b5e-3fe8-e053-6394a90ad6c4	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	0897cc86-c775-8821-e063-6394a90a6fcf	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel -Patch	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	4bdec2ee-37ee-86ea-e063-6294a90a49fd	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	2d76dd9a-6291-ae75-e063-6394a90a30e6	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	31a099c4-91d8-352a-e063-6394a90a035f	2026-05-14	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Patch	LIDOCAINE	GERI-CARE PHARMACEUTICAL CORP	51b7753b-8619-6ea9-e063-6294a90a4ea4	2026-05-13	Warnings	Name fallback generic name: LIDOCAINE
Stud 100 Male Genital Desensitizer	LIDOCAINE	Pound International Corp	d075656e-b13f-4a1d-bbb6-501e642698d5	2026-05-12	Warnings	Name fallback generic name: LIDOCAINE
BonicaEaseX Pain Relieving Lidocaine	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	7486fe89-a377-4a37-997d-e3bd16b891a7	2026-05-11	Warnings	Name fallback generic name: LIDOCAINE
Walmart Equate Aloe Sunburn Relief Cooling	LIDOCAINE	WAL-MART STORES INC.	51540f6b-596f-bc47-e063-6294a90a46ae	2026-05-08	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine 4% Cream	LIDOCAINE	Medcore LLC	111cb421-ba3b-4772-ab60-d31eb4183168	2026-05-07	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine 5% Cream	LIDOCAINE	Medcore LLC	15d02b42-bf8b-486a-a081-f6d17cc11ec7	2026-05-07	Warnings	Name fallback generic name: LIDOCAINE
Lidoxi	LIDOCAINE	T&T Pharma Holdings LLC	513c517e-c098-02aa-e063-6294a90ac8a4	2026-05-07	Warnings	Name fallback generic name: LIDOCAINE
TheraCare Flexible Pain Relieving	LIDOCAINE	Veridian Healthcare	4f108002-2cae-0671-e063-6294a90ab6cf	2026-04-30	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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