LIDOTHOL

Product NDC: 76420-149
11-digit product format: 764200149
Labeler code: 76420
Product ID: 76420-149_e425b6aa-1427-785f-e053-2a95a90a4350
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE, MENTHOL
Dosage form: PATCH
Route: TOPICAL
Labeler: Asclemed USA, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2015-06-16
Marketing end: 0000-00-00
Substance: LIDOCAINE; MENTHOL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76420-149		D	Discontinued by firm		2026-10-12
excluded package	package	76420-149	76420-149-15	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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76420-149-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76420-149-15	`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
76420-149-15	EA - Each	76420-149	8f50b8b5-7726-4bab-ac96-71f30c808bfc	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-149	LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [ASCLEMED USA, INC.]	1	Legacy NDC	20220722_658c4ba1-5f71-48d2-9acb-becad5fa9b3e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-149-15	76420014915	15 PATCH in 1 BOX (76420-149-15) > 1 PATCH in 1 PATCH	15 patch	2022-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lidothol Patch	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-07-19	HUMAN PRESCRIPTION DRUG LABEL	1