Lidocaine

Product NDC: 0591-2679
11-digit product format: 005912679
Labeler code: 0591
Product ID: 0591-2679_e0683309-89ba-4804-887f-12fcaf59a2ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: PATCH
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: ANDA200675
Marketing category: ANDA
Marketing start: 2014-07-01
Marketing end: 2026-12-31
Substance: LIDOCAINE
Active strength: 50 mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
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
A200675-001	LIDOCAINE	LIDOCAINE	5%	PATCH / TOPICAL	AB		2012-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200675-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200675-001	LIDOCAINE	5%	PATCH / TOPICAL	AB	2012-08-23	`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	A200675-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200675-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200675-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200675-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200675-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200675-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200675-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200675-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200675-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200675-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200675-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200675-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200675-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200675-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200675-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200675-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200675-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200675-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200675-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200675-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200675-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200675-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200675-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200675-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200675-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200675-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200675-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200675-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200675-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200675-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200675-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200675-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200675-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200675-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200675-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200675-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200675-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200675-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200675-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200675-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lidocaine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	50 mg/g

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
c18799cd-9e11-4196-9ab1-0a2a84585e56	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-2679-11	Lidocaine	1 g in 1 POUCH	PATCH	1		10
0591-2679-30	Lidocaine	30 in 1 CARTON	PATCH	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2679-11	EA - Each	0591-2679	509cbb77-0311-4b48-a15a-94dd59b6ca39	1	2019-02-13
0591-2679-30	EA - Each	0591-2679	f50d77eb-e656-4ef2-82d1-17de342dacca	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
DIHYDROXYALUMINUM AMINOACETATE	INACTIVE INGREDIENT	DO250MG0W6	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2679	LIDOCAINE PATCH [ACTAVIS PHARMA, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20250212_c18799cd-9e11-4196-9ab1-0a2a84585e56.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tridacaine II	LIDOCAINE	Trifluent Pharma LLC	1e940ba6-3916-4fc4-8886-481fc9685fc1	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	PureTek Corporation	85e72943-6989-42f4-b519-a3ebbf4bc777	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Cardinal Health 107, LLC	eb808fdf-0420-45e9-ad17-8380d49d5c21	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Actavis Pharma, Inc.	c18799cd-9e11-4196-9ab1-0a2a84585e56	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675 ndc (product): 0591-2679
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	4e856dd5-f2fa-4acb-a205-f87baf26b8cc	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	1d28d687-695e-4cd9-97e2-7d4fdab9772a	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	6d7fdc43-e493-449e-9af6-825e584b547a	2023-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	80dadfb5-cbe6-475f-9980-a1b255982753	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	Actavis Pharma, Inc.	4d04052c-3e0a-469a-9265-99604f13e507	2022-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675
Lidocaine	LIDOCAINE	AVKARE	ec6a4720-9821-c0fc-e053-2995a90a05df	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200675 application number: ANDA200675

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	c18799cd-9e11-4196-9ab1-0a2a84585e56	10
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	c18799cd-9e11-4196-9ab1-0a2a84585e56	10
1745091	lidocaine 5 % Medicated Patch	SY	c18799cd-9e11-4196-9ab1-0a2a84585e56	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2679-11	00591267911	1 g in 1 POUCH	1 g					Historical
0591-2679-30	00591267930	30 POUCH in 1 CARTON (0591-2679-30) / 1 g in 1 POUCH (0591-2679-11)	30 pouch	2014-07-01	2026-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Patch NovaPlus A200675	Actavis Pharma, Inc.	2025-08-26	HUMAN PRESCRIPTION DRUG LABEL	10