Lidocaine Hydrochloride

Product NDC: 52584-013
11-digit product format: 525840013
Labeler code: 52584
Product ID: 52584-013_690f91ba-c99a-4b1e-a1cd-334e36a9cbc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: JELLY
Route: TOPICAL
Labeler: General Injectables & Vaccines, Inc
Application: ANDA086283
Marketing category: ANDA
Marketing start: 2010-09-01
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52584-013		I	Inactivated by FDA		2026-08-03
excluded package	package	52584-013	52584-013-00	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 · 34 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-013-00	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52584-013-00	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52584-013-00	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52584-013-00	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52584-013-00	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52584-013-00	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52584-013-00	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52584-013-00	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52584-013-00	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52584-013-00	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52584-013-00	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52584-013-00	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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 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
52584-013-00	2020-01-31	C162847	48780-1	9d75b9d0-701e-f424-e053-dadaa90a57ce	Lidocaine HCL Jelly, USP, 2% 20 mg/mL 10 mL Sterile Pak Uro-Jet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52584-013-00	Lidocaine Hydrochloride	20 mL in 1 VIAL, SINGLE-USE	JELLY	20		4
52584-013-00	Lidocaine Hydrochloride	1 in 1 BAG	JELLY	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Lidocaine Hydrochloride	ACTIVE INGREDIENT	V13007Z41A	LIDOCAINE HYDROCHLORIDE JELLY [GENERAL INJECTABLES & VACCINES, INC]	3
Lidocaine	ACTIVE MOIETY	98PI200987	LIDOCAINE HYDROCHLORIDE JELLY [GENERAL INJECTABLES & VACCINES, INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52584-013	LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE) JELLY [GENERAL INJECTABLES & VACCINES, INC]	4	Legacy NDC, 2 package rows	20170112_fa8f924b-bc1d-4864-923b-b1d4234504cd.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 · 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1011852	lidocaine HCl 2 % Topical Gel	PSN	fa8f924b-bc1d-4864-923b-b1d4234504cd	4
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	fa8f924b-bc1d-4864-923b-b1d4234504cd	4
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	fa8f924b-bc1d-4864-923b-b1d4234504cd	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52584-013-00	52584001300	20 mL in 1 VIAL, SINGLE-USE	20 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidocaine HCL Jelly, USP, 2% 20 mg/mL 10 mL Sterile Pak Uro-Jet	General Injectables & Vaccines, Inc	2017-01-11	HUMAN PRESCRIPTION DRUG LABEL	4