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 20 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hempvana Ultra Strength Pain Relief - Overnight	LIDOCAINE	Telebrands Corp	1030d478-6805-6579-e063-6294a90a0c76	2024-12-02	Warnings	Name fallback generic name: LIDOCAINE
Zensa	LIDOCAINE	Alera Skin Care Products Inc.	f56146b6-3c11-4608-a6ab-6142f27e9ac3	2024-11-24	Warnings	Name fallback generic name: LIDOCAINE
Signature Care Lidocaine Cream	LIDOCAINE	Better Living Brands LLC	5483729e-ef1a-47a2-b7cf-c19744f52073	2024-11-21	Warnings	Name fallback generic name: LIDOCAINE
Hemorrhoid Pain Relief	LIDOCAINE	Telebrands Corp	04164425-ca3b-ef24-e063-6294a90a59d8	2024-11-20	Warnings	Name fallback generic name: LIDOCAINE
Hempvana Maximum Strength Pain Relief Topical Anesthetic	LIDOCAINE	Telebrands Corp	f525075a-d7ee-dad0-e053-2a95a90a6f3f	2024-11-20	Warnings	Name fallback generic name: LIDOCAINE
Hempvana Ultra Strength Pain Relief	LIDOCAINE	TELEBRANDS CORP	d91ba9b1-083f-32e9-e053-2a95a90a9bd1	2024-11-20	Warnings	Name fallback generic name: LIDOCAINE
Curist Lidocaine Numbing Relief	LIDOCAINE	Little Pharma, Inc.	bff3c422-a0df-6196-e053-2a95a90af033	2024-11-20	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Patrin Pharma Inc.	91eedf9d-53b8-49d5-af59-25019606a0b2	2024-11-15	Warnings	Name fallback generic name: LIDOCAINE
Tylenol Precise Warming Pain Relieving	LIDOCAINE	Kenvue Brands LLC	0c60b607-ade9-68f2-e063-6394a90a4025	2024-11-13	Warnings	Name fallback generic name: LIDOCAINE
Tylenol Precise Pain Relieving	LIDOCAINE	Kenvue Brands LLC	fc1e0451-8c84-729e-e053-6394a90aaba0	2024-11-13	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Anorectal	LIDOCAINE	Patrin Pharma, Inc	456d41fe-8449-4980-9291-d7a3b65a900d	2024-11-13	Warnings	Name fallback generic name: LIDOCAINE
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	26c7116f-c86d-8752-e063-6294a90ab73f	2024-11-12	Warnings	Name fallback generic name: LIDOCAINE
CVS Health Lidocaine Cream	LIDOCAINE	CVS Health	ad950680-c03c-4fa5-aa7f-239a889cd097	2024-11-12	Warnings	Name fallback generic name: LIDOCAINE
BENGAY Tropical Jasmine	LIDOCAINE	Kenvue Brands LLC	c416320a-c0d7-401e-b0fa-44114d76a557	2024-11-06	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Numbing Cream	LIDOCAINE	Yyba Corp	fe986c22-a30c-4d60-90d0-5d41e0b91958	2024-11-06	Warnings	Name fallback generic name: LIDOCAINE
Ztlido	LIDOCAINE	Scilex Pharmaceuticals Inc.	a1b17507-4560-490d-a388-74e7fd7eaa5e	2024-11-01	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	STRATUS PHARMACEUTICALS INC	87a4f559-a4f6-4b9f-98de-b55b073a11c6	2024-11-01	Warnings	Name fallback generic name: LIDOCAINE
lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	259f7b21-98c7-3b41-e063-6294a90a34fa	2024-10-29	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
LIDOCAINE	LIDOCAINE	Advanced Rx of Tennessee, LLC	259f3f4b-50d0-066c-e063-6394a90a2a1e	2024-10-29	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	1f46bdfd-3a38-49a3-a505-0192790486d0	2024-10-28	Warnings, Adverse reactions	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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