Lidocaine

Product NDC: 72189-601
11-digit product format: 721890601
Labeler code: 72189
Product ID: 72189-601_4d3aaeaa-fcfc-e423-e063-6394a90a9528
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Direct_rx
Application: ANDA212695
Marketing category: ANDA
Marketing start: 2024-12-23
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212695-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2021-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212695-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212695-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2021-04-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212695-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212695-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212695-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212695-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212695-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212695-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212695-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212695-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212695-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212695-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212695-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212695-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212695-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212695-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212695-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212695-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212695-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212695-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212695-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212695-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212695-001	AT	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212695-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212695-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212695-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212695-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212695-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212695-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212695-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212695-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212695-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212695-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212695-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212695-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212695-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212695-001	AT	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Lidocaine
Listing expiration: 2027-12-31

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
29f211ff-dcba-afb0-e063-6294a90afb9b	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	Strength	SPL version
72189-601-35	Lidocaine	35 g in 1 CARTON	OINTMENT	35		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-601-35	GM - Gram	72189-601	26d440f4-1931-4a89-9b13-9ddca10b0af8	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-601	LIDOCAINE OINTMENT [DIRECT_RX]	1	Current NDC, 1 package rows	20241225_29f211ff-dcba-afb0-e063-6294a90afb9b.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	A-S Medication Solutions	3fbe48b5-128a-471c-8ecb-45e903b56740	2026-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695
Lidocaine	LIDOCAINE	Direct_rx	29f211ff-dcba-afb0-e063-6294a90afb9b	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695 ndc (product): 72189-601
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	4e679a0d-df82-435f-ad46-c871f3c76dfb	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	015cea25-d323-43dd-a92f-593a8e4a2921	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695
Lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	325ddb61-84f5-075c-e063-6294a90ad5e9	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695
Lidocaine	LIDOCAINE	QUAGEN PHARMACEUTICALS LLC	f8789807-cc0c-485c-aa98-1bdc39337deb	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212695 application number: ANDA212695

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	29f211ff-dcba-afb0-e063-6294a90afb9b	2
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	29f211ff-dcba-afb0-e063-6294a90afb9b	2
1543069	lidocaine 5 % Topical Ointment	SY	29f211ff-dcba-afb0-e063-6294a90afb9b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-601-35	72189060135	35 g in 1 CARTON (72189-601-35)	35 g	2024-12-23	No	No	Current