Lidocaine 5%

Product NDC: 80175-0118
11-digit product format: 801750118
Labeler code: 80175
Product ID: 80175-0118_be39192c-c4e4-ee5f-e053-2a95a90aacd7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: PATCH
Route: TOPICAL
Labeler: Central Packaging
Application: ANDA209190
Marketing category: ANDA
Marketing start: 2020-05-14
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	80175-0118		I	Inactivated by FDA		2026-08-03
excluded package	package	80175-0118	80175-0118-3	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

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

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	80175-0118		I	Inactivated by FDA		excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	80175-0118	80175-0118-3	I	Inactivated by FDA		excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80175-0118-3	Lidocaine 5%	1 in 1 PATCH	PATCH	1		1
80175-0118-3	Lidocaine 5%	30 in 1 PACKAGE	PATCH	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80175-0118	LIDOCAINE 5% (LIDOCAINE) PATCH [CENTRAL PACKAGING]	1	Legacy NDC, 2 package rows	20210213_bb173e93-6932-5996-e053-2a95a90a3225.zip

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	bb173e93-6932-5996-e053-2a95a90a3225	1
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	bb173e93-6932-5996-e053-2a95a90a3225	1
1745091	lidocaine 5 % Medicated Patch	SY	bb173e93-6932-5996-e053-2a95a90a3225	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80175-0118-3	80175011803	30 PATCH in 1 PACKAGE (80175-0118-3) > 1 POUCH in 1 PATCH > 1 PATCH in 1 POUCH	30 patch	2020-05-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine 5% - Central Packaging \| Central Packaging, LLC	Central Packaging \| Central Packaging, LLC	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	1