Lidocaine Hydrochloride

Product NDC: 50090-5599
Requested package NDC: 50090-5599-0
11-digit product format: 500905599
Labeler code: 50090
Product ID: 50090-5599_5e66584b-58f4-4434-8164-b867449aa274
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: SOLUTION
Route: OROPHARYNGEAL
Labeler: A-S Medication Solutions
Application: ANDA040708
Marketing category: ANDA
Marketing start: 2021-04-01
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: 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	50090-5599	50090-5599-0	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	LIDOCAINE HYDROCHLORIDE	2%	SOLUTION / ORAL	AT		2007-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040708-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	RS	2007-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL			2007-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL			2007-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	RS	2007-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	RS	2007-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT	RS	2007-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040708-001	LIDOCAINE HYDROCHLORIDE VISCOUS	2%	SOLUTION / ORAL	AT		2007-02-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040708-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040708-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040708-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040708-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040708-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040708-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040708-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040708-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040708-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040708-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040708-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040708-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040708-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040708-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040708-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040708-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040708-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040708-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040708-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040708-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040708-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040708-001	AT	1	`5aa47cf7b7d7…`
2019-12-14 00:12 UTC	2019-12	A040708-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040708-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040708-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040708-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040708-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040708-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040708-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040708-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040708-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040708-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040708-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040708-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040708-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040708-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040708-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040708-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040708-001	AT	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5599-0	2023-01-30	C162847	48780-1	f386c64a-3c57-0266-e053-dadaa90a7c1a	LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION USP, 2% (Viscous)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5599-0	Lidocaine Hydrochloride	100 mL in 1 BOTTLE	SOLUTION	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5599	LIDOCAINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 1 package rows	20210806_cbd6a12e-661f-4463-bfa9-18163ac0b159.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Chartwell RX, LLC	c05f49a2-7512-48e7-9730-f8ee05519b9d	2026-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040708 application number: ANDA040708
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	f79b8b30-67ed-4daa-8233-ee2319592ef0	2026-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040708 application number: ANDA040708

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010739	lidocaine HCl 2 % Mucous Membrane Topical Solution	PSN	cbd6a12e-661f-4463-bfa9-18163ac0b159	1
1010739	lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical Solution	SCD	cbd6a12e-661f-4463-bfa9-18163ac0b159	1
1010739	lidocaine HCl 2 % Oral Topical Solution	SY	cbd6a12e-661f-4463-bfa9-18163ac0b159	1
1010739	lidocaine HCl 2 % Oromucosal Solution	SY	cbd6a12e-661f-4463-bfa9-18163ac0b159	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5599-0	50090559900	100 mL in 1 BOTTLE (50090-5599-0)	100 ml	2021-07-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIDOCAINE HYDROCHLORIDE ORAL TOPICAL SOLUTION USP, 2% (Viscous)	A-S Medication Solutions	2021-08-05	HUMAN PRESCRIPTION DRUG LABEL	1