Lidocaine

Product NDC: 72189-488
Requested package NDC: 72189-488-50
11-digit product format: 721890488
Labeler code: 72189
Product ID: 72189-488_2c4e3760-8444-4adb-e063-6394a90a5ffc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Direct_Rx
Application: ANDA211697
Marketing category: ANDA
Marketing start: 2023-06-07
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-488	72189-488-50	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-488	72189-488-50	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A211697-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2020-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211697-001	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	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211697-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2020-03-16	`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	A211697-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211697-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211697-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211697-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211697-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211697-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211697-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211697-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211697-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211697-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211697-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211697-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211697-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211697-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211697-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211697-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211697-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211697-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211697-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211697-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211697-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211697-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211697-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211697-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211697-001	AT	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211697-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211697-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211697-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211697-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211697-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211697-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211697-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211697-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211697-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211697-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211697-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211697-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211697-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211697-001	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: 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
fd8a640a-b5ca-f0a7-e053-6394a90ad603	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-488-50	Lidocaine	50 g in 1 CARTON	OINTMENT	50		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-488-50	GM - Gram	72189-488	5a5a6830-9613-492e-8a21-eb984f38077b	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-488	LIDOCAINE OINTMENT [DIRECT_RX]	2	Current NDC, 1 package rows	20250123_fd8a640a-b5ca-f0a7-e053-6394a90ad603.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	REMEDYREPACK INC.	9bf01533-ed83-4440-bdc4-4b45729bfc31	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211697 application number: ANDA211697
Lidocaine	LIDOCAINE	Macleods Pharmaceuticals Limited	c788afd3-4554-40c4-8f26-2c31ab9b9b98	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211697 application number: ANDA211697
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	e0bfe16f-7a3f-48e0-a2e6-2ec68159a888	2026-03-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211697 application number: ANDA211697
Lidocaine	LIDOCAINE	Direct_Rx	fd8a640a-b5ca-f0a7-e053-6394a90ad603	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211697 application number: ANDA211697 ndc (package): 72189-488-50 ndc (product): 72189-488 ndc11 (package): 72189048850

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	fd8a640a-b5ca-f0a7-e053-6394a90ad603	2
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	fd8a640a-b5ca-f0a7-e053-6394a90ad603	2
1543069	lidocaine 5 % Topical Ointment	SY	fd8a640a-b5ca-f0a7-e053-6394a90ad603	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-488-50	72189048850	50 g in 1 CARTON (72189-488-50)	50 g	2023-06-07	No	No	Current