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 15 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Extra Small Lidocaine	LIDOCAINE	Walgreen Co.	dc838e47-d234-4ba5-9449-f645e99be923	2025-06-18	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Stratus Pharmaceuticals Inc	5eb6574c-2066-4390-befc-8e5d2dd6ede2	2025-06-12	Warnings	Name fallback generic name: LIDOCAINE
Bunnies Bum Anorectal Numbing	LIDOCAINE	FloCal Distributors LLC	3712e151-d171-1c5d-e063-6294a90a36c0	2025-06-08	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Cardinal Health 107, LLC	fa69dfdf-ab73-48a9-944d-25e88d7766df	2025-06-05	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	36c9988b-9e61-ebbf-e063-6394a90a4114	2025-06-04	Warnings	Name fallback generic name: LIDOCAINE
Quick Numb	LIDOCAINE	Clinical Resolution Laboratory, Inc.	351b95a6-e038-d9aa-e063-6294a90a4172	2025-05-29	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	ATLANTIC BIOLOGICALS CORP.	1e8239f6-8d53-4b04-8bf8-c2cefe3ab5c3	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
MAXOCAINE Topical Anesthetic Anorectal	LIDOCAINE	PRIME COMMERCE, LLC	26e8c867-8cb8-4a25-91b1-da45a1edd09a	2025-05-27	Warnings	Name fallback generic name: LIDOCAINE
Numb25	LIDOCAINE	Ebanel Laboratories, Inc.	35107403-55ae-c627-e063-6394a90a0b5c	2025-05-27	Warnings	Name fallback generic name: LIDOCAINE
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	350e4d5e-dac7-ae4e-e063-6394a90a76b4	2025-05-27	Warnings	Name fallback generic name: LIDOCAINE
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	35095bed-0e91-c44a-e063-6294a90add6e	2025-05-27	Warnings	Name fallback generic name: LIDOCAINE
AUVON Pain Relief Cream	LIDOCAINE	SHENZHEN YUWEN E-COMMERCE CO., LTD.	358c2632-3b90-1c54-e063-6294a90ad461	2025-05-22	Warnings	Name fallback generic name: LIDOCAINE
Numbing Cream	LIDOCAINE	100 KARMA INC	359884d6-188a-e503-e063-6294a90acab4	2025-05-20	Warnings	Name fallback generic name: LIDOCAINE
Numbing Cream	LIDOCAINE	100 KARMA INC	35884644-d017-eda3-e063-6394a90a1f6c	2025-05-19	Warnings	Name fallback generic name: LIDOCAINE
VBBV Tattoo Numbing	LIDOCAINE	Jiashen International Trade Limited	3557859e-f8b3-1049-e063-6394a90ad737	2025-05-17	Warnings	Name fallback generic name: LIDOCAINE
Numb520	LIDOCAINE	Clinical Resolution Laboratory, Inc.	a0411950-c6ee-4427-acb6-3cef58b0e93e	2025-05-15	Warnings	Name fallback generic name: LIDOCAINE
Numb25	LIDOCAINE	Clinical Resolution Laboratory, Inc.	cfcb839d-47b4-4925-bb30-97b64d20d2b3	2025-05-15	Warnings	Name fallback generic name: LIDOCAINE
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	Solis Pharmaceuticals Inc.	3061d301-2104-b1b2-e063-6394a90a9b6e	2025-04-29	Warnings	Name fallback generic name: LIDOCAINE
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	InterMed Laboratories Private Limited	33ed754e-8852-d5b2-e063-6394a90a7cf2	2025-04-29	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	32b96689-8e9b-4c2e-e063-6294a90a7d1c	2025-04-29	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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