LIDOTHOL

Product NDC: 68788-7405
Requested package NDC: 68788-7405-1
11-digit product format: 687887405
Labeler code: 68788
Product ID: 68788-7405_6f96bd2e-c0dd-4df1-b353-359d5288491e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE, MENTHOL
Dosage form: PATCH
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2018-06-11
Marketing end: 0000-00-00
Substance: LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength: 5 g/1; g/1
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	68788-7405	68788-7405-1	D	Discontinued by firm		2026-10-12

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-7405	68788-7405-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-7405	68788-7405-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7405-1	EA - Each	68788-7405	aefd5d53-865e-4e0f-8a5f-76293d0b83b0	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7405	LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS INC.]	7	Legacy NDC	20240621_be735f23-ef9d-45cf-8eb1-7a65a4cf09ae.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7405-1	68788740501	15 PATCH in 1 BOX (68788-7405-1) > 1 PATCH in 1 PATCH	15 patch	2018-06-11	0000-00-00	No	No	Current