LidoPro

Product NDC
53225-1022
11-digit product format
532251022
Labeler code
53225
Product ID
53225-1022_dae4366f-57fa-003e-e053-2a95a90a1ffa
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin, Lidocaine, Menthol, and Methyl Salicylate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Terrain Pharmaceuticals
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-01-01
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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53225-1022DDiscontinued by firm2026-10-05
excluded packagepackage53225-102253225-1022-1DDiscontinued by firm2026-10-05
excluded packagepackage53225-102253225-1022-3DDiscontinued 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 · 34 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 packagepackage53225-1022-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53225-1022-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53225-1022-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53225-1022-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53225-1022-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53225-1022-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53225-1022-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53225-1022-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53225-1022-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53225-1022-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53225-1022-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53225-1022-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53225-1022-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53225-1022-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53225-1022-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53225-1022-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53225-1022-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53225-1022-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53225-1022-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53225-1022-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53225-1022-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53225-1022-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53225-1022-3557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53225-1022-1GM - Gram53225-1022664bc9f1-64a7-464d-8bda-61847ab1119612015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
MENTHOLACTIVE INGREDIENTL7T10EIP3ALIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
CAPSAICINACTIVE MOIETYS07O44R1ZMLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
LIDOCAINEACTIVE MOIETY98PI200987LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
MENTHOLACTIVE MOIETYL7T10EIP3ALIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
ALLANTOININACTIVE INGREDIENT344S277G0ZLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZGLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
WATERINACTIVE INGREDIENT059QF0KO0RLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [TERRAIN PHARMACEUTICALS]4
CAPSAICINACTIVE INGREDIENTS07O44R1ZMLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ALIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
CAPSAICINACTIVE MOIETYS07O44R1ZMLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ALIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0ZLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZGLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentPSN7f672876-477c-4333-a7de-53f3121906611
1601097LidoPro 0.0325 % / 4 % / 10 % / 27.5 % Topical OintmentPSN7f672876-477c-4333-a7de-53f3121906611
1601097capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical Ointment [LidoPro]SBD7f672876-477c-4333-a7de-53f3121906611
1601095capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical OintmentSCD7f672876-477c-4333-a7de-53f3121906611
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentSY7f672876-477c-4333-a7de-53f3121906611
1601097LidoPro (capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % ) Topical OintmentSY7f672876-477c-4333-a7de-53f3121906611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53225-1022-153225102201121 g in 1 BOTTLE (53225-1022-1) 121 g2014-01-010000-00-00NoNoCurrent
53225-1022-353225102203300 PACKET in 1 CARTON (53225-1022-3) > 2.5 g in 1 PACKET (53225-1022-2) 300 packet2014-01-010000-00-00NoNoCurrent
53225-1022-45322510220426 g in 1 TUBE (53225-1022-4) 26 g2014-01-010000-00-00NoNoCurrent