LidoPro

Product NDC
76420-038
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76420-038DDiscontinued by firm2026-10-05
excluded productproduct76420-038DDiscontinued by firm2026-10-05
excluded packagepackage76420-03876420-038-12DDiscontinued by firm2026-10-05
excluded packagepackage76420-03876420-038-92DDiscontinued by firm2026-10-05

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76420-038-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76420-038-92d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76420-038-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76420-038-92f5e01cc5f278…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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-038-12GM - Gram76420-038032f6299-ed95-422e-8ccb-14115f71296b12022-10-06
76420-038-92GM - Gram76420-0386b730a32-df13-46f8-94ae-34f4e09bc9f012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-038LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [ASCLEMED USA, INC.]3Legacy NDC20231016_e48aa0ab-6aed-4dae-8e1c-dfae2e70f303.zip
76420-038LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [ASCLEMED USA, INC.]2Legacy NDC20231016_e8ee1f03-f369-416b-a366-c1879a6c0a7b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-038-1276420003812121 g in 1 BOTTLE (76420-038-12) 121 g2020-02-050000-00-00NoNoCurrent
76420-038-927642000389292 g in 1 BOTTLE (76420-038-92) 92 g2023-01-070000-00-00NoNoCurrent