Lidocaine

Product NDC: 71205-137
11-digit product format: 712050137
Labeler code: 71205
Product ID: 71205-137_d8a112aa-934b-45b2-a18c-6cbb5ffb162c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Proficient Rx LP
Application: ANDA206297
Marketing category: ANDA
Marketing start: 2016-08-15
Marketing end: 0000-00-00
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: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71205-137		D	Discontinued by firm		2026-08-17
excluded package	package	71205-137	71205-137-52	D	Discontinued by firm		2026-08-17

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 · 4 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	71205-137-52	`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	71205-137-52	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A206297-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2015-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206297-001	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	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206297-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2015-08-07	`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	A206297-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206297-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206297-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206297-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206297-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206297-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206297-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206297-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206297-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206297-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206297-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206297-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206297-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206297-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206297-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206297-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206297-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206297-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206297-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206297-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206297-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206297-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206297-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206297-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206297-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206297-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206297-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206297-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206297-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206297-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206297-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206297-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206297-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206297-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206297-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206297-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206297-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206297-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206297-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206297-001	AT	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-137-52	GM - Gram	71205-137	01969712-d4ac-4a9c-b468-79a89b4069b4	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-137	LIDOCAINE OINTMENT [PROFICIENT RX LP]	3	Legacy NDC	20191022_5c32a824-8239-4776-99da-fe386017c174.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	960f6d0a-82af-45e9-89d5-cea808004ebb	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Preferred Pharmaceuticals Inc.	4806f94d-cbac-4107-b93b-8f715868ffb3	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	PHOENIX RX LLC	40949067-a5a8-db8c-e063-6294a90af0fb	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f18b8413-8f52-a927-e053-2a95a90a402a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f93cbde5-329a-f880-e053-6294a90a1af2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	6fe7721d-42b3-4284-936b-a448ca530c45	2023-09-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297
Lidocaine	LIDOCAINE	Amneal Pharmaceuticals LLC	d1509740-f9f1-44e3-8fde-51d8683fcd87	2018-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206297 application number: ANDA206297

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-137-52	71205013752	1 TUBE in 1 CARTON (71205-137-52) > 283.52 g in 1 TUBE	1 tube	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Ointment USP, 5% FOR TOPICAL USEDO NOT USE IN THE EYES Rx Only	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	3