Lidocaine

Product NDC: 80425-0325
11-digit product format: 804250325
Labeler code: 80425
Product ID: 80425-0325_2a9bfe6a-6d70-b262-e063-6294a90a1cf3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: PATCH
Route: TOPICAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA206463
Marketing category: ANDA
Marketing start: 2023-04-14
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 43.

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
A206463-001	LIDOCAINE	LIDOCAINE	5%	PATCH / TOPICAL	AB		2020-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206463-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206463-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-08-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206463-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206463-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206463-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206463-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206463-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206463-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206463-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206463-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206463-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206463-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206463-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206463-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206463-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206463-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206463-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206463-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206463-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206463-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206463-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206463-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206463-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206463-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206463-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206463-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206463-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206463-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206463-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206463-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206463-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206463-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206463-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206463-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206463-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206463-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206463-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206463-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206463-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206463-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206463-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Lidocaine
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
f94d388c-8471-885b-e053-6294a90ab67a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0325-1	Lidocaine	1 in 1 POUCH	PATCH	1		2
80425-0325-1	Lidocaine	30 in 1 CARTON	PATCH	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0325-1	EA - Each	80425-0325	d4b8b38d-209e-4d6d-a233-98876f073f06	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0325	LIDOCAINE PATCH [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 2 package rows	20250102_f94d388c-8471-885b-e053-6294a90ab67a.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	PHOENIX RX LLC	57edfcb8-272c-8af4-e063-6294a90ae2e5	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	ASCLEMED USA INC.	56a54ef4-7aa0-e181-e063-6394a90a3e0e	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	ebc05cf9-e82b-4f7d-b5e7-3e62025ce68c	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine Patch	LIDOCAINE PATCH	Direct_Rx	eb503f1f-cd3a-ab76-e053-2995a90ab1c8	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Sportpharm LLC	1112681c-8de7-472b-8db4-2702054b835b	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	A-S Medication Solutions	82bb7767-5407-4593-b6d4-90859890e376	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	AvKARE	0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f94d388c-8471-885b-e053-6294a90ab67a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463 ndc (product): 80425-0325
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	1f46bdfd-3a38-49a3-a505-0192790486d0	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	b4db5684-988f-44c4-a81e-5c04b8b0f6e7	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	19c585f3-e635-44d4-8eb0-14529eb34dca	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206463 application number: ANDA206463

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	f94d388c-8471-885b-e053-6294a90ab67a	2
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	f94d388c-8471-885b-e053-6294a90ab67a	2
1745091	lidocaine 5 % Medicated Patch	SY	f94d388c-8471-885b-e053-6294a90ab67a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0325-1	80425032501	30 POUCH in 1 CARTON (80425-0325-1) / 1 PATCH in 1 POUCH	30 pouch	2023-04-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Patch	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2