LidoPro

Product NDC: 76420-038
Requested package NDC: 76420-038-12
11-digit product format: 764200038
Labeler code: 76420
Product ID: 76420-038_f1a57b27-6d50-70b5-e053-2a95a90a5470
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin, Lidocaine, Menthol, and Methyl Salicylate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Asclemed USA, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2022-07-08
Marketing end: 0000-00-00
Substance: CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE
Active strength: 0 g/g; g/g; g/g; g/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2024-12-31
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	76420-038	76420-038-12	D	Discontinued by firm		2026-10-05

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	76420-038	76420-038-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76420-038	76420-038-12	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
76420-038-12	GM - Gram	76420-038	032f6299-ed95-422e-8ccb-14115f71296b	1	2022-10-06
76420-038-92	GM - Gram	76420-038	6b730a32-df13-46f8-94ae-34f4e09bc9f0	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-038	LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [ASCLEMED USA, INC.]	3	Legacy NDC	20231016_e48aa0ab-6aed-4dae-8e1c-dfae2e70f303.zip
76420-038	LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [ASCLEMED USA, INC.]	2	Legacy NDC	20231016_e8ee1f03-f369-416b-a366-c1879a6c0a7b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-038-12	76420003812	121 g in 1 BOTTLE (76420-038-12)	121 g	2020-02-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LidoPro 4%	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-10-16	HUMAN OTC DRUG LABEL	3
LidoPro 4% Ointment	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-10-16	HUMAN OTC DRUG LABEL	2