FDA.reportPublic FDA data

LidoPro Patch

Product NDC
80425-0374
11-digit product format
804250374
Labeler code
80425
Product ID
80425-0374_128d3176-c38f-bf72-e063-6394a90aeaf5
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol, and Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-29
Substance
LIDOCAINE; MENTHOL; METHYL SALICYLATE
Active strength
4; .5; .1 mg/100mg; mg/100mg; mg/100mg
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
LidoPro Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 mg/100mg
MENTHOL.5 mg/100mg
METHYL SALICYLATE.1 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2675022Internal RxNorm lookup
2675024Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
128d0ba9-bc9d-af16-e063-6394a90af5efAvailable on FDA.report

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
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0374-1LidoPro Patch15 in 1 BOXPATCH151
80425-0374-1LidoPro Patch2 in 1 POUCHPATCH21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0374-1EA - Each80425-0374d53c7621-bc05-4e10-807c-840937eb338b12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0374LIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 2 package rows20240302_128d0ba9-bc9d-af16-e063-6394a90af5ef.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 101 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cortizone 10 Soothing Aloe Itch ReliefHYDROCORTISONEChattem, Inc.1962abb3-6ca7-4934-9efe-20287b1c2a5b2025-02-01WarningsExact identifier
application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLCd4276749-eeff-28f7-e053-2a95a90a593d2025-01-31WarningsExact identifier
application number: M017
MyDerm Bite ReliefBENZOCAINEInspec Solutions LLC.88615668-16b5-7840-e053-2a95a90a92082025-01-31WarningsExact identifier
application number: M017
Maximum Strength Blue Emu Pain Relief Blu EmuTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC5e02b820-e53a-42cb-abdb-2925617c29ca2025-01-31WarningsExact identifier
application number: M017
Sunset Novelties HerquakeNUMBING LUBRICANTSUNSET INTIMATES GROUP INC2ceeca3e-9197-9166-e063-6394a90ae9082025-01-30WarningsExact identifier
application number: M017
Magsoothium CBD Cooling Roll on ReliefMENTHOLUbu/Elements, Inc.2cf05dcd-6a44-de08-e063-6394a90aaba02025-01-30WarningsExact identifier
application number: M017
Meijer Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMMeijer, Inc.dac73a07-7569-4788-977a-f10d098da75d2025-01-30WarningsExact identifier
application number: M017
ZCort UltraHYDROCORTISONE ACETATE 1%RxDino, LLCb68f8ada-58e8-e8e4-e053-2a95a90ab02d2025-01-29WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINE 4%Noble OTC LLC12a3ce63-6fce-0993-e063-6294a90a40d52025-01-28WarningsExact identifier
application number: M017
INTIMALE LIDOCAINE DELAYLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED5ddd7d56-bf51-462b-afcd-944861e497812025-01-28WarningsExact identifier
application number: M017
CBD Clinic Relax MassageCAMPHORABACUS HEALTH PRODUCTS, INC.f0eae24e-09cf-0d2d-e053-2a95a90acedc2025-01-28WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebbc0f-9888-b812-e053-2a95a90a5d3d2025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Arthritis Aches and Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec7255-bb36-41cd-e053-2a95a90aeac42025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Back and Neck Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec8fc9-c401-5f23-e053-2995a90acb1c2025-01-28WarningsExact identifier
application number: M017
Muscle TherapyMETHYL SALICYLATE, CAMPHOREverlaan Organics Inc0890a683-9a66-fdbd-e063-6294a90ae5262025-01-27WarningsExact identifier
application number: M017
Joint TherapyCAMPHOREverlaan Organics Inc08904b77-d6db-8b82-e063-6394a90ace4f2025-01-27WarningsExact identifier
application number: M017
Warrior Arthritis ReliefTROLAMIN SALICYLATE 10%Derma Care Research Labs, LLC013f48b9-913f-b283-e063-6394a90abd732025-01-27WarningsExact identifier
application number: M017
DCH Cool and HeatMENTHOL 16%Derma Care Research Labs, LLCff323282-612c-eaf8-e053-6394a90ab7792025-01-27WarningsExact identifier
application number: M017
GerigentleHYDROCORTISONEGERI-GENTLE CORPORATION0adfa2f0-9758-5c54-e063-6294a90a461f2025-01-25WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative Inc.42f1abeb-f6d7-01c3-e054-00144ff88e882025-01-23WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675022lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % Medicated PatchPSN128d0ba9-bc9d-af16-e063-6394a90af5ef1
2675024LidoPro Patch 4 % / 0.5 % / 0.1 % Medicated PatchPSN128d0ba9-bc9d-af16-e063-6394a90af5ef1
2675024lidocaine 0.04 MG/MG / menthol 0.005 MG/MG / methyl salicylate 0.001 MG/MG Medicated Patch [LidoPro Patch]SBD128d0ba9-bc9d-af16-e063-6394a90af5ef1
2675022lidocaine 0.04 MG/MG / menthol 0.005 MG/MG / methyl salicylate 0.001 MG/MG Medicated PatchSCD128d0ba9-bc9d-af16-e063-6394a90af5ef1
2675022lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % Medicated PatchSY128d0ba9-bc9d-af16-e063-6394a90af5ef1
2675024LidoPro Patch (lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % ) Medicated PatchSY128d0ba9-bc9d-af16-e063-6394a90af5ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0374-18042503740115 POUCH in 1 BOX (80425-0374-1) / 2 PATCH in 1 POUCH / 8500 mg in 1 PATCH15 pouch2024-02-29NoNoCurrent