Lidocaine

Product NDC: 64380-789
11-digit product format: 643800789
Labeler code: 64380
Product ID: 64380-789_e6c9429c-13b9-4932-abad-e605c4c7fb68
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Strides Pharma Science Limited
Application: ANDA210958
Marketing category: ANDA
Marketing start: 2019-01-01
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 42.

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
A210958-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2018-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210958-001	AT

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 · 42 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
2026-08-18 06:07:40	2026-07	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210958-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-12-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210958-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210958-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210958-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210958-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210958-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210958-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210958-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210958-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210958-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210958-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210958-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210958-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210958-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210958-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210958-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210958-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210958-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210958-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210958-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210958-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210958-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210958-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210958-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210958-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210958-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210958-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210958-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210958-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210958-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210958-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210958-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210958-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210958-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210958-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210958-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210958-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210958-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210958-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210958-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210958-001	AT	1	`e64feba35796…`

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
1543069	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
8b1efeaa-31b1-4f34-960f-7a920ac07355	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
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	SPL version
64380-789-23	Lidocaine	30 g in 1 TUBE	OINTMENT	30	4
64380-789-32	Lidocaine	35.44 g in 1 TUBE	OINTMENT	35.44	4
64380-789-33	Lidocaine	50 g in 1 JAR	OINTMENT	50	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-789-23	GM - Gram	64380-789	cabe49b8-d14a-419d-bc87-d7c785ddee0d	1	2019-08-06
64380-789-32	GM - Gram	64380-789	f842f254-c43e-4a45-9ba0-6c21fdc75a23	1	2019-08-06
64380-789-33	GM - Gram	64380-789	d00b6f01-38fe-4a38-b951-43513e782ba1	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-789	LIDOCAINE OINTMENT [STRIDES PHARMA SCIENCE LIMITED]	4	Current NDC, Legacy NDC, 3 package rows	20190101_8b1efeaa-31b1-4f34-960f-7a920ac07355.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Direct_Rx	feb8692a-9c08-0d5c-e053-6394a90a904b	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210958 application number: ANDA210958
Lidocaine	LIDOCAINE	Proficient Rx LP	2b9150ea-a876-4511-8d5b-aa72507ef863	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210958 application number: ANDA210958
Lidocaine	LIDOCAINE	Strides Pharma Science Limited	8b1efeaa-31b1-4f34-960f-7a920ac07355	2018-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210958 application number: ANDA210958 ndc (product): 64380-789

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
1543069	lidocaine 5 % Topical Ointment	PSN	8b1efeaa-31b1-4f34-960f-7a920ac07355	4
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	8b1efeaa-31b1-4f34-960f-7a920ac07355	4
1543069	lidocaine 5 % Topical Ointment	SY	8b1efeaa-31b1-4f34-960f-7a920ac07355	4
1543069	lidocaine 5 % Topical Ointment	PSN	feb8692a-9c08-0d5c-e053-6394a90a904b	2
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	feb8692a-9c08-0d5c-e053-6394a90a904b	2
1543069	lidocaine 5 % Topical Ointment	SY	feb8692a-9c08-0d5c-e053-6394a90a904b	2
1543069	lidocaine 5 % Topical Ointment	PSN	2718a56f-345f-4d88-82d2-364e0f155d97	1
1543069	lidocaine 5 % Topical Ointment	PSN	2b9150ea-a876-4511-8d5b-aa72507ef863	1
1543069	lidocaine 5 % Topical Ointment	PSN	5e05fbdf-3495-48e5-bdf4-188c069dd1f8	1
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	2718a56f-345f-4d88-82d2-364e0f155d97	1
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	2b9150ea-a876-4511-8d5b-aa72507ef863	1
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	5e05fbdf-3495-48e5-bdf4-188c069dd1f8	1
1543069	lidocaine 5 % Topical Ointment	SY	2718a56f-345f-4d88-82d2-364e0f155d97	1
1543069	lidocaine 5 % Topical Ointment	SY	2b9150ea-a876-4511-8d5b-aa72507ef863	1
1543069	lidocaine 5 % Topical Ointment	SY	5e05fbdf-3495-48e5-bdf4-188c069dd1f8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-789-23	64380078923	30 g in 1 TUBE (64380-789-23)	30 g	2019-01-01	0000-00-00	No	No	Current
64380-789-32	64380078932	35.44 g in 1 TUBE (64380-789-32)	35.44 g	2019-01-01	0000-00-00	No	No	Current
64380-789-33	64380078933	50 g in 1 JAR (64380-789-33)	50 g	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Lidocaine Ointment USP, 5%	Unit Dose Services	2023-07-13	HUMAN PRESCRIPTION DRUG LABEL	1
Lidocaine Ointment USP, 5%	UNIT DOSE SERVICES	2023-07-11	HUMAN PRESCRIPTION DRUG LABEL	1
Lidocaine Ointment USP, 5%	Proficient Rx LP	2023-06-01	HUMAN PRESCRIPTION DRUG LABEL	1
Lidocaine Ointment USP, 5%	Preferred Pharmaceuticals Inc.	2022-07-26	HUMAN PRESCRIPTION DRUG LABEL	2
Lidocaine Ointment USP, 5%	Strides Pharma Science Limited	2018-12-14	HUMAN PRESCRIPTION DRUG LABEL	4