Lidocaine

Product NDC: 76420-037
Requested package NDC: 76420-037-30
11-digit product format: 764200037
Labeler code: 76420
Product ID: 76420-037_ead14e8e-059a-1ebb-e053-2995a90a78b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: PATCH
Route: TOPICAL
Labeler: Asclemed USA, Inc.
Application: ANDA200675
Marketing category: ANDA
Marketing start: 2013-09-15
Substance: LIDOCAINE
Active strength: 50 mg/g
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
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
Listing expiration: 2026-12-31

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
80dadfb5-cbe6-475f-9980-a1b255982753	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-037-30	Lidocaine	1 g in 1 POUCH	PATCH	1		2
76420-037-30	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
76420-037-30	EA - Each	76420-037	7509a627-d765-48c9-8567-4bc15178b4d3	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-037	LIDOCAINE PATCH [ASCLEMED USA, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20221013_80dadfb5-cbe6-475f-9980-a1b255982753.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
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 ndc (package): 76420-037-30 ndc (product): 76420-037 ndc11 (package): 76420003730
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	80dadfb5-cbe6-475f-9980-a1b255982753	2
1745091	lidocaine 0.05 MG/MG Medicated Patch	SCD	80dadfb5-cbe6-475f-9980-a1b255982753	2
1745091	lidocaine 5 % Medicated Patch	SY	80dadfb5-cbe6-475f-9980-a1b255982753	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-037-30	76420003730	30 POUCH in 1 CARTON (76420-037-30) / 1 g in 1 POUCH	30 pouch	2020-02-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Patch A200675	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-10-12	HUMAN PRESCRIPTION DRUG LABEL	2