Lidocaine Hydrochloride

Product NDC: 55154-9626
Requested package NDC: 55154-9626-5
11-digit product format: 551549626
Labeler code: 55154
Product ID: 55154-9626_4e8b4b70-c716-427d-bf0a-b7988af06883
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: SOLUTION
Route: ORAL; TOPICAL
Labeler: Cardinal Health 107, LLC
Application: ANDA040014
Marketing category: ANDA
Marketing start: 1995-07-10
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE ANHYDROUS
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: 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	55154-9626	55154-9626-5	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A040014-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		1995-07-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL			1995-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040014-001	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT	RS	1995-07-10	`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	A040014-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040014-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040014-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040014-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040014-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040014-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040014-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040014-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040014-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040014-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040014-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040014-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040014-001	AT	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040014-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040014-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040014-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040014-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040014-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040014-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040014-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040014-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040014-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040014-001	AT	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	EC2CNF7XFP	LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]	2
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]	2
ORANGE	INACTIVE INGREDIENT	5EVU04N5QU	LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	LIDOCAINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]	2

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5a41d694-4628-4911-e053-2991aa0a91e5	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040014 application number: ANDA040014

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EC2CNF7XFP	LIDOCAINE HYDROCHLORIDE ANHYDROUS	73-78-9	LIDOCAINE HYDROCHLORIDE ANHYDROUS
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	Lidocaine Hydrochloride

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-9626-5	55154962605	5 CUP, UNIT-DOSE in 1 BAG (55154-9626-5) > 15 mL in 1 CUP, UNIT-DOSE	1995-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION, USP (VISCOUS) 2%	Cardinal Health 107, LLC	2023-03-14	HUMAN PRESCRIPTION DRUG LABEL	8