Lidocaine

Product NDC: 68071-4628
Requested package NDC: 68071-4628-5
11-digit product format: 680714628
Labeler code: 68071
Product ID: 68071-4628_bbf25e24-4c09-d303-e053-2a95a90a634d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lidocaine
Dosage form: OINTMENT
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA205318
Marketing category: ANDA
Marketing start: 2017-02-27
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-4628	68071-4628-5	D	Discontinued by firm		2026-08-03

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A205318-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2016-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205318-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL		2016-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205318-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2016-02-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205318-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205318-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205318-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205318-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205318-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205318-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205318-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205318-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205318-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205318-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205318-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205318-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205318-001	AT	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A205318-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205318-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205318-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205318-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205318-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205318-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205318-001	AT	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-12	LIDOCAINE OINTMENT USP, 5%
2023-01-30	LIDOCAINE OINTMENT USP, 5%
2021-02-22	LIDOCAINE OINTMENT USP, 5%
2021-01-29	LIDOCAINE OINTMENT USP, 5%

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	LIDICAINE	Encube Ethicals, Inc.	e9f80c8a-05ba-47f8-aff1-e2583b2f8e57	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205318 application number: ANDA205318
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	c18f0c2b-cd05-4458-888f-47b4a1106937	2020-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205318 application number: ANDA205318
Lidocaine	LIDOCAINE	Proficient Rx LP	cbf01b82-c43f-4bed-a1df-7569f4816c76	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205318 application number: ANDA205318

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
68071-4628-5	68071462805	50 g in 1 BOX (68071-4628-5)	50 g	2018-11-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIDOCAINE OINTMENT USP, 5%	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	2