Lidocaine 5%

Product NDC: 70518-3522
11-digit product format: 705183522
Labeler code: 70518
Product ID: 70518-3522_f111ff5f-fadd-f0bd-e053-2995a90a1639
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine 5%
Dosage form: PATCH
Route: TOPICAL
Labeler: REMEDYREPACK INC.
Application: ANDA209190
Marketing category: ANDA
Marketing start: 2022-09-14
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-3522		D	Discontinued by firm		2026-08-03
excluded package	package	70518-3522	70518-3522-0	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3522-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3522-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-3522-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-3522-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-3522-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-3522-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-3522-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-3522-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-3522-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-3522-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-3522-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-3522-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A209190-001	LIDOCAINE	LIDOCAINE	5%	PATCH / TOPICAL	AB		2020-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209190-001	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
2026-02-19 14:30 UTC	2026-02	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209190-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2020-04-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209190-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209190-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209190-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209190-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209190-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209190-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209190-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209190-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209190-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209190-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209190-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209190-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209190-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209190-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209190-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209190-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209190-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209190-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209190-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209190-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209190-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209190-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209190-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209190-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209190-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209190-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209190-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209190-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209190-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209190-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209190-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209190-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209190-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209190-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209190-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209190-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209190-001	AB	1	`a50c72e98297…`

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 5%	LIDOCAINE 5%	St. Mary's Medical Park Pharmacy	052fa8a3-0e3c-d9c2-e063-6394a90aadd7	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidox 5 Patch	LIDOCAINE 5% PATCH	Injecta Medcial LLC	526b8681-098f-3410-e063-6294a90a79fb	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocaine 5%	LIDOCAINE 5%	YARAL Pharma Inc.	fc495fc8-15d6-27c7-e053-6394a90ab30d	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocan	LIDOCAINE 5%	PURETEK CORPORATION	fd8e4856-3785-4850-e053-6294a90a95b6	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocaine 5%	LIDOCAINE 5%	A-S Medication Solutions	fec1e759-60e4-47d4-bd54-947f18b103dd	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocaine 5% Patch	LIDOCAINE 5%	Medcore LLC	1afe428f-e223-4ef8-a6ba-968f4cfbf476	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Tridacaine III	LIDOCAINE	Trifluent Pharma LLC	9b47102e-3b35-4aa7-a380-cd02ba9eac65	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Tridacaine XL	LIDOCAINE	Trifluent Pharma LLC	032b37a7-8a47-4809-a330-c76314225cbd	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocaine 5%	LIDOCAINE 5%	REMEDYREPACK INC.	50152ae0-aebd-4a08-a5c7-c8858e025997	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocaine 5%	LIDOCAINE 5%	Asclemed USA, Inc.	1dca5b81-72a9-4969-8552-d43091f72aab	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocan VI	LIDOCAINE 5%	PURETEK CORPORATION	1b6dc518-a15b-1cf9-e063-6294a90a6357	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocan VII	LIDOCAINE 5%	PURETEK CORPORATION	1f33d51c-168c-55f2-e063-6394a90a8905	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocan IV	LIDOCAINE 5%	PURETEK CORPORATION	137f9cc1-68c0-edcc-e063-6394a90abf6a	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocan V	LIDOCAINE 5%	PURETEK CORPORATION	141fe2bd-b25a-eff8-e063-6294a90a2ae8	2024-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocan III	LIDOCAINE 5%	PURETEK CORPORATION	07a258e4-4858-43b3-e063-6394a90a5084	2024-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190
Lidocaine 5%	LIDOCAINE 5%	NuCare Pharmaceuticals,Inc.	1ac8a196-010f-a986-e063-6294a90a948f	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209190 application number: ANDA209190

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3522-0	70518352200	30 POUCH in 1 PACKAGE (70518-3522-0) > 1 PATCH in 1 POUCH	30 pouch	2022-09-14	0000-00-00	No	No	Current