LIDOCAINE HYDROCHLORIDE

Product NDC: 60432-465
Requested package NDC: 60432-465-51
11-digit product format: 604320465
Labeler code: 60432
Product ID: 60432-465_c39cdf5f-718a-4427-8bec-52ba31002e5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lidocaine hydrochloride
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Morton Grove Pharmaceuticals, Inc.
Application: ANDA087881
Marketing category: ANDA
Marketing start: 1982-11-18
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 40 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	60432-465	60432-465-51	D	Discontinued by firm		2026-09-14

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 43.

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
A087881-001	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT		1982-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087881-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL		1982-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL		1982-11-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL		1982-11-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL		1982-11-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087881-001	LIDOCAINE HYDROCHLORIDE	4%	SOLUTION / TOPICAL	AT	1982-11-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A087881-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087881-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087881-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087881-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087881-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087881-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087881-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087881-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087881-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087881-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087881-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087881-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087881-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087881-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087881-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087881-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087881-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087881-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087881-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A087881-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087881-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087881-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087881-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087881-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087881-001	AT	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087881-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087881-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087881-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087881-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087881-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087881-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087881-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087881-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087881-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087881-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087881-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087881-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087881-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A087881-001	AT	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-12-10	LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%
2024-01-30	LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%
2023-11-03	LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%
2023-07-28	LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60432-465-50	ML - Milliliter	60432-465	23cc87b3-e479-48fe-86dd-a54a9f3066ac	1	2012-07-24
60432-465-51	ML - Milliliter	60432-465	b27f5470-4ce5-430c-9b2e-fccc598ec373	1	2022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Lidocaine Hydrochloride	ACTIVE INGREDIENT	V13007Z41A	LIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Lidocaine	ACTIVE MOIETY	98PI200987	LIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	LIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	LIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	LIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Water	INACTIVE INGREDIENT	059QF0KO0R	LIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60432-465	LIDOCAINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	11	Legacy NDC	20220311_521d6be9-72d9-4662-a62e-afc70197d620.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	Bryant Ranch Prepack	8f79b023-9bd1-4bd6-8fd0-f9efe88abec0	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087881 application number: ANDA087881
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	Xttrium Laboratories, Inc.	31a5a48e-27d7-90f3-e063-6294a90a2d9e	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087881 application number: ANDA087881

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
60432-465-51	60432046551	1 BOTTLE, GLASS in 1 CARTON (60432-465-51) > 50 mL in 1 BOTTLE, GLASS (60432-465-50)	1982-11-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION, USP 4%	Morton Grove Pharmaceuticals, Inc. \| Societa Italiana Medicinali Scandicci S.I.M.S. SrL - Italy	2022-03-10	HUMAN PRESCRIPTION DRUG LABEL	11