Lidocaine

Product NDC: 57539-0221
11-digit product format: 575390221
Labeler code: 57539
Product ID: 57539-0221_460ea4ed-64ab-4fe2-aac2-6dca496a204d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Novocol Inc.
Application: ANDA040911
Marketing category: ANDA
Marketing start: 2011-10-01
Marketing end: 0000-00-00
Substance: LIDOCAINE
Active strength: 5 g/100g
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57539-0221		I	Inactivated by FDA	2026-10-16
excluded package	package	57539-0221	57539-0221-1	I	Inactivated by FDA	2026-10-16
excluded package	package	57539-0221	57539-0221-5	I	Inactivated by FDA	2026-10-16

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57539-0221-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57539-0221-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57539-0221-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57539-0221-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57539-0221-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57539-0221-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57539-0221-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57539-0221-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57539-0221-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57539-0221-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57539-0221-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57539-0221-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57539-0221-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57539-0221-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57539-0221-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57539-0221-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57539-0221-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57539-0221-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57539-0221-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57539-0221-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57539-0221-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57539-0221-5	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57539-0221-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57539-0221-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57539-0221-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57539-0221-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57539-0221-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57539-0221-5	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57539-0221-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57539-0221-5	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57539-0221-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57539-0221-5	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57539-0221-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57539-0221-5	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57539-0221-1	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57539-0221-5	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57539-0221-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57539-0221-5	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57539-0221-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57539-0221-5	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A040911-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2011-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040911-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040911-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2011-05-23	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A040911-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040911-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040911-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040911-001	AT	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57539-0221-1	2019-11-13	C162847	48780-1	97449f38-c122-f6ea-e053-dbdaa90aa703	LIDOCAINE OINTMENT USP, 5%
57539-0221-5	2019-11-13	C162847	48780-1	97449f38-c122-f6ea-e053-dbdaa90aa703	LIDOCAINE OINTMENT USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57539-0221-1	Lidocaine	50 g in 1 JAR	OINTMENT	50	1
57539-0221-5	Lidocaine	35.44 g in 1 TUBE	OINTMENT	35.44	1
57539-0221-5	Lidocaine	1 in 1 CARTON	OINTMENT	1	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Lidocaine	ACTIVE INGREDIENT	98PI200987	LIDOCAINE OINTMENT [NOVOCOL INC.]	1
Lidocaine	ACTIVE MOIETY	98PI200987	LIDOCAINE OINTMENT [NOVOCOL INC.]	1
Polyethylene Glycol 1450	INACTIVE INGREDIENT	OJ4Z5Z32L4	LIDOCAINE OINTMENT [NOVOCOL INC.]	1
Polyethylene Glycol 300	INACTIVE INGREDIENT	5655G9Y8AQ	LIDOCAINE OINTMENT [NOVOCOL INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57539-0221	LIDOCAINE OINTMENT [NOVOCOL INC.]	1	Legacy NDC, 3 package rows	20120328_c66b3509-c670-4124-86ac-da313958aabd.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Septodont, Inc.	82a4c16f-d47e-479f-8f85-7d1be6fc2318	2023-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040911 application number: ANDA040911

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	c66b3509-c670-4124-86ac-da313958aabd	1
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	c66b3509-c670-4124-86ac-da313958aabd	1
1543069	lidocaine 5 % Topical Ointment	SY	c66b3509-c670-4124-86ac-da313958aabd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57539-0221-1	57539022101	50 g in 1 JAR	50 g	Historical
57539-0221-5	57539022105	35.44 g in 1 TUBE	35.44 g	Historical