LIDODERM

Product NDC: 61959-001
11-digit product format: 619590001
Labeler code: 61959
Product ID: 61959-001_eedfe43b-1019-19a0-e053-2995a90a7696
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Patch 5%
Dosage form: PATCH
Route: TOPICAL
Labeler: TPU Pharma, Inc.
Application: NDA020612
Marketing category: NDA
Marketing start: 2023-03-01
Substance: LIDOCAINE
Active strength: 700 mg/1
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020612-001	LIDODERM	LIDOCAINE	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020612-001	AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020612-001	LIDODERM	5%	PATCH / TOPICAL	AB	RLD, RS	1999-03-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020612-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020612-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020612-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020612-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020612-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020612-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020612-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020612-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020612-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020612-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020612-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020612-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020612-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020612-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020612-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020612-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020612-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020612-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020612-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020612-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020612-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020612-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020612-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020612-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020612-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020612-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020612-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020612-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020612-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020612-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020612-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020612-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020612-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020612-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020612-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020612-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020612-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020612-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020612-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020612-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: LIDODERM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	700 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98PI200987	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1011705	Internal RxNorm lookup
1745091	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
db0092f5-02a0-4076-ac32-969f075a6ab1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61959-001-01	LIDODERM	1 in 1 POUCH	PATCH	1		3
61959-001-30	LIDODERM	30 in 1 CARTON	PATCH	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61959-001-01	EA - Each	61959-001	b40ddb1f-54e4-4fa4-b80b-23fc29c20ef6	1	2023-05-05
61959-001-30	EA - Each	61959-001	39d1b6c9-556a-42ba-9de1-94c22e711e5c	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61959-001	LIDODERM (LIDOCAINE PATCH 5%) PATCH [TPU PHARMA, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20230301_db0092f5-02a0-4076-ac32-969f075a6ab1.zip

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 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	St. Mary's Medical Park Pharmacy	9dc3059c-3a3d-5810-e053-2a95a90ab0ba	2026-06-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Golden State Medical Supply, Inc.	0bef12dd-6cea-d12b-e063-6394a90a002e	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Par Health USA, LLC	2ce8a4fe-8aa6-4dc5-ad0f-3984ae68c4bc	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	323e0ec2-c2e5-47d1-a39f-69ff5c99e324	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
LIDOCAINE	LIDOCAINE	DIRECT RX	a575bcb8-478f-1f7e-e053-2995a90a4b12	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Sportpharm LLC	4611f0da-a41d-4861-9dd6-f16f1b007d33	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	PHOENIX RX LLC	3c69e03c-e176-2c23-e063-6394a90aa41f	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	REMEDYREPACK INC.	0748b9e3-1247-4eeb-8158-3d641b2ad85d	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	A-S Medication Solutions	e23a92e6-3445-4ba7-9ad2-86a3eec1717e	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Cardinal Health 107, LLC	fa69dfdf-ab73-48a9-944d-25e88d7766df	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	REMEDYREPACK INC.	94ab1b99-e203-4a14-b852-42d3b37999c3	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	f7ada189-7463-4bc7-83e7-f140558ecacf	2024-12-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Quality Care Products LLC	f20ab860-e49a-4f3f-868e-6a60780af5a7	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	1b561cc6-1d36-e259-e063-6294a90aacbd	2024-06-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	65cf652c-87f2-43c6-a6f8-e4a83b42ce78	2024-01-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612
LIDODERM	LIDOCAINE PATCH 5%	TPU Pharma, Inc.	db0092f5-02a0-4076-ac32-969f075a6ab1	2022-12-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020612 application number: NDA020612 ndc (product): 61959-001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1745091	lidocaine 5 % Medicated Patch	PSN	db0092f5-02a0-4076-ac32-969f075a6ab1	3
1011705	Lidoderm 5 % Medicated Patch	PSN	db0092f5-02a0-4076-ac32-969f075a6ab1	3
1011705	lidocaine 0.05 MG/MG Medicated Patch [Lidoderm]	SBD	db0092f5-02a0-4076-ac32-969f075a6ab1	3
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	db0092f5-02a0-4076-ac32-969f075a6ab1	3
1745091	lidocaine 5 % Medicated Patch	SY	db0092f5-02a0-4076-ac32-969f075a6ab1	3
1011705	Lidoderm 0.05 MG/MG Medicated Patch	SY	db0092f5-02a0-4076-ac32-969f075a6ab1	3
1011705	Lidoderm 5 % Medicated Patch	SY	db0092f5-02a0-4076-ac32-969f075a6ab1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61959-001-01	61959000101	1 in 1 POUCH						Historical
61959-001-30	61959000130	30 POUCH in 1 CARTON (61959-001-30) / 1 PATCH in 1 POUCH (61959-001-01)	30 pouch	2023-03-01	0000-00-00	No	No	Current