LIDOCAINE

Product NDC: 68788-7766
11-digit product format: 687887766
Labeler code: 68788
Product ID: 68788-7766_06ee40a9-f599-4e7f-9d16-697734d6df15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA211469
Marketing category: ANDA
Marketing start: 2020-08-03
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: 2027-12-31
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 · 24 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	68788-7766-5	`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	68788-7766-5	`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	68788-7766-5	`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	68788-7766-5	`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	68788-7766-5	`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	68788-7766-5	`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	68788-7766-5	`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	68788-7766-5	`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	68788-7766-5	`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	68788-7766-5	`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	68788-7766-5	`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	68788-7766-5	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A211469-001	LIDOCAINE	LIDOCAINE	5%	OINTMENT / TOPICAL	AT		2018-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211469-001	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	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	BX	2018-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	BX	2018-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	BX	2018-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211469-001	LIDOCAINE	5%	OINTMENT / TOPICAL	AT	2018-11-23	`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	A211469-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211469-001	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211469-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211469-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211469-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211469-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211469-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211469-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211469-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211469-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211469-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211469-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211469-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211469-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211469-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211469-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211469-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211469-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211469-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211469-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211469-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211469-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211469-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211469-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211469-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211469-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211469-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211469-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211469-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211469-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211469-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211469-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211469-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211469-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211469-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211469-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211469-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211469-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211469-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211469-001	AT	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: LIDOCAINE
Listing expiration: 2027-12-31

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
e7ed90d7-11c0-4781-a727-1fe3659a2948	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-7766-5	LIDOCAINE	50 g in 1 JAR	OINTMENT	50		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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOCAINE	LIDOCAINE	Preferred Pharmaceuticals, Inc.	e7ed90d7-11c0-4781-a727-1fe3659a2948	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211469 application number: ANDA211469 ndc (product): 68788-7766
LIDOCAINE	LIDOCAINE	REMEDYREPACK INC.	dfef4554-aeb4-4bdf-9557-648d3e84af3c	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211469 application number: ANDA211469
LIDOCAINE	LIDOCAINE	PHOENIX RX LLC	3a63652c-92a1-612b-e063-6294a90a034a	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211469 application number: ANDA211469
LIDOCAINE	LIDOCAINE	Alembic Pharmaceuticals Limited	071b2cfd-07ad-46a3-8808-87080d545fd3	2025-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211469 application number: ANDA211469
LIDOCAINE	LIDOCAINE	Quality Care Products, LLC	38f31902-99fd-4a63-853e-b5f93dfc5980	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211469 application number: ANDA211469
LIDOCAINE	LIDOCAINE	Advanced Rx of Tennessee, LLC	259f3f4b-50d0-066c-e063-6394a90a2a1e	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211469 application number: ANDA211469
LIDOCAINE	LIDOCAINE	Proficient Rx LP	c98eeb63-c896-4417-b0ad-66c4a87efeee	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211469 application number: ANDA211469
LIDOCAINE	LIDOCAINE	Alembic Pharmaceuticals Inc.	11a8b27a-1e25-46e5-bc23-ae5c894b4da4	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211469 application number: ANDA211469

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	e7ed90d7-11c0-4781-a727-1fe3659a2948	5
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	e7ed90d7-11c0-4781-a727-1fe3659a2948	5
1543069	lidocaine 5 % Topical Ointment	SY	e7ed90d7-11c0-4781-a727-1fe3659a2948	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7766-5	68788776605	50 g in 1 JAR (68788-7766-5)	50 g	2020-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine Ointment USP, 5% FOR TOPICAL USE ONLY. DO NOT USE IN THE EYES Rx Only	Preferred Pharmaceuticals, Inc.	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	5