LIDOCAINE

Product NDC: 61919-774
Requested package NDC: 61919-774-50
11-digit product format: 619190774
Labeler code: 61919
Product ID: 61919-774_e9ac0631-9341-ad58-e053-2a95a90a588f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: DIRECTRX
Application: ANDA205318
Marketing category: ANDA
Marketing start: 2019-04-01
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: 2023-12-31
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	61919-774	61919-774-50	I	Inactivated by FDA		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 · 9 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	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-774-35	2025-01-30	C162847	48780-1	2cef2736-99f0-d83d-e063-dadaa90ab31f	LIDOCAINE OINTMENT
61919-774-50	2025-01-30	C162847	48780-1	2cef2736-99f0-d83d-e063-dadaa90ab31f	LIDOCAINE OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-774-35	LIDOCAINE	35.44 g in 1 TUBE	OINTMENT	35.44		3
61919-774-50	LIDOCAINE	50 g in 1 CARTON	OINTMENT	50		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-774-35	GM - Gram	61919-774	462d1908-8e45-41ad-8822-369d91dd6122	1	2019-05-02
61919-774-50	GM - Gram	61919-774	087d1447-d650-4654-a0c9-38e7eb277722	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-774	LIDOCAINE OINTMENT [DIRECTRX]	3	Legacy NDC, 2 package rows	20230519_857bf526-ab2a-b173-e053-2991aa0a04cf.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1543069	lidocaine 5 % Topical Ointment	PSN	857bf526-ab2a-b173-e053-2991aa0a04cf	3
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	857bf526-ab2a-b173-e053-2991aa0a04cf	3
1543069	lidocaine 5 % Topical Ointment	SY	857bf526-ab2a-b173-e053-2991aa0a04cf	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-774-50	61919077450	50 g in 1 CARTON (61919-774-50)	50 g	2022-09-27	0000-00-00	No	No	Current