Lidocaine Hydrochloride

Product NDC: 55154-3953
11-digit product format: 551543953
Labeler code: 55154
Product ID: 55154-3953_c84d6e4b-bc77-4abc-b002-4fe0c077ec0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: JELLY
Route: TOPICAL
Labeler: Cardinal Health
Application: ANDA086283
Marketing category: ANDA
Marketing start: 1979-08-07
Marketing end: 2019-11-30
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	55154-3953		D	Discontinued by firm		2026-08-03
excluded package	package	55154-3953	55154-3953-8	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 · 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	55154-3953-8	`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	55154-3953-8	`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	55154-3953-8	`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	55154-3953-8	`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	55154-3953-8	`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	55154-3953-8	`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	55154-3953-8	`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	55154-3953-8	`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	55154-3953-8	`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	55154-3953-8	`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	55154-3953-8	`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	55154-3953-8	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A086283-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086283-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086283-001	LIDOCAINE HYDROCHLORIDE	2%	JELLY / TOPICAL	AT	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086283-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086283-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086283-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086283-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086283-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086283-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086283-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086283-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086283-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086283-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086283-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086283-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086283-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086283-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086283-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086283-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086283-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086283-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086283-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086283-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086283-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086283-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086283-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086283-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086283-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086283-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086283-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086283-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086283-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086283-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086283-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086283-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086283-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086283-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086283-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086283-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086283-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086283-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086283-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086283-001	AT	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	LIDOCAINE HYDROCHLORIDE JELLY [CARDINAL HEALTH]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE HYDROCHLORIDE JELLY [CARDINAL HEALTH]	1

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 Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	f73d4546-c9ac-4155-8492-552d6ce70c84	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	f0617ab8-555f-4cbe-9795-c922f5ef176e	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Henry Schein, Inc.	ddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	International Medication Systems, Limited	0cbc37d3-c2d6-4747-9834-7c23b38fcc20	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c4bf5905-add7-1cb0-e053-2995a90a7334	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c4c0df51-cc37-323d-e053-2995a90a154a	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283
LIDOCAINE HCI	LIDOCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	95351883-ec37-f94a-e053-2995a90aa36a	2024-01-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086283 application number: ANDA086283