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 14 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	015cea25-d323-43dd-a92f-593a8e4a2921	2025-08-07	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
lidocaine pain relief patches	LIDOCAINE	Changsha Maocheng Trading Co., Ltd	3afeead3-4f5c-4711-e063-6294a90aacca	2025-07-28	Warnings	Name fallback generic name: LIDOCAINE
AIPATCH NUMBING PAIN RELIEF	LIDOCAINE	Active Intelligence, LLC	56f27540-9b2a-4266-9e15-a5b2d738c7a1	2025-07-25	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	3a9a6630-e470-b794-e063-6394a90aaab5	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Arthcal 4% Lidocaine Patches	LIDOCAINE	Beijing JUNGE Technology Co., Ltd.	2e531194-67ad-c645-e063-6394a90a916c	2025-07-22	Warnings	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	PHOENIX RX LLC	3a63652c-92a1-612b-e063-6294a90a034a	2025-07-21	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
OTC Rescue Lidocaine Pain Relief Patch	LIDOCAINE	Veridian Healthcare	0e742fc6-5f76-d202-e063-6394a90acf31	2025-07-16	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Golden State Medical Supply, Inc.	b948d6fe-3893-39a1-e053-2995a90ae64c	2025-07-11	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
INVIGOR OH	LIDOCAINE	Natureplex LLC	7c7b536d-e41a-4017-9df9-982e2e9cfe4e	2025-07-10	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Sun Pharmaceutical Industries, Inc.	ae758020-a508-4a2e-8164-e6c324e826a3	2025-07-02	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Syntherma Plus	LIDOCAINE	V2 Pharma, LLC	1a312322-9c4a-4f14-be7f-05ccad1601bf	2025-07-01	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
4 Lidocaine Topical Anesthetic	LIDOCAINE	RUGBY LABORATORIES	63327e57-f4c8-4ae6-9d28-cef8697bbdcc	2025-06-27	Warnings	Name fallback generic name: LIDOCAINE
Orythia Pain Relieving Lidocaine	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	d658d495-dd2c-40b7-9446-6f10040ed55e	2025-06-27	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Patch	LIDOCAINE	Shenzhen Finona Information Technology Co., Ltd	3875bde5-2e1a-5fdf-e063-6294a90a3c0d	2025-06-26	Warnings	Name fallback generic name: LIDOCAINE
Medline	LIDOCAINE	Medline Industries, LP	0d6d0d4e-60d5-74b2-e063-6294a90a2da6	2025-06-26	Warnings	Name fallback generic name: LIDOCAINE
Hilook Blue Gel Anesthetic	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	1b9db681-a297-5aa9-e063-6394a90a80ea	2025-06-25	Warnings	Name fallback generic name: LIDOCAINE
Hilook Numbing Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	1b9f1a4c-ca0b-d820-e063-6394a90a3239	2025-06-25	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Knee Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	384c1ff8-80bd-86cb-e063-6394a90a2d65	2025-06-24	Warnings	Name fallback generic name: LIDOCAINE
Elemar Patch	LIDOCAINE	V2 Pharma, LLC	3de6bb95-3673-45c4-bf11-90ec858c37d9	2025-06-20	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
MyDerm	LIDOCAINE	Inspec Solutions LLC.	82d075d1-c92e-2097-e053-2991aa0ab131	2025-06-18	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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