FDA.reportPublic FDA data

LidoPro Patch (Lidocaine 4%, Menthol 1%)

Product NDC
83881-402
11-digit product format
838810402
Labeler code
83881
Product ID
83881-402_57ad9d0c-8d7b-aaa7-e063-6294a90a3a68
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine and Menthol Patch
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Clinic Pharma
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-09
Substance
MENTHOL; LIDOCAINE
Active strength
84; 336 mg/8400mg; mg/8400mg
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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 (Lidocaine 4%, Menthol 1%)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL84 mg/8400mg
LIDOCAINE336 mg/8400mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1249758Internal RxNorm lookup
2675625Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b4d2105-b7ad-2695-e063-6394a90a999bAvailable 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83881-402-05LidoPro Patch (Lidocaine 4%, Menthol 1%)5 mg in 1 POUCHPATCH51
83881-402-15LidoPro Patch (Lidocaine 4%, Menthol 1%)15 mg in 1 POUCHPATCH151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83881-402-15EA - Each83881-4025d361496-6b99-4115-a5e9-56c801effab012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83881-402LIDOPRO PATCH (LIDOCAINE 4%, MENTHOL 1%) (LIDOCAINE AND MENTHOL PATCH) PATCH [CLINIC PHARMA]1Current NDC, 2 package rows20250114_2b4d2105-b7ad-2695-e063-6394a90a999b.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 89 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aloe Up SPF 50 MineralZINC OXIDEAloe International, LLC35bc3621-f4e4-42d3-e063-6394a90a7aad2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDEAloe International, LLC35cd5542-947d-a042-e063-6394a90a13f82025-06-18WarningsExact identifier
application number: M017
Relieve Your PainMENTHOLProximity Capital Partners LLC dba Asutrac12369dd-8305-edaf-e053-2995a90a0d3d2025-06-18WarningsExact identifier
application number: M017
Melt Pain AwayCAPSAICINProximity Capital Partners LLC dba Asutraa95a11d7-a2ae-6654-e053-2a95a90a802c2025-06-18WarningsExact identifier
application number: M017
Recovery Roll-OnMENTHOL, CAMPHORPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRAebc9630f-6d8b-e4f0-e053-2995a90a0b492025-06-18WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37cdfabc-1fdb-246a-e063-6394a90a008a2025-06-17WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37ce6c35-b211-43de-e063-6294a90ab7732025-06-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Sun Pharmaceutical Industries, Inc.312ddc8d-100e-cfac-e063-6294a90acd092025-06-16WarningsExact identifier
application number: M017
Curist 5% LidocaineLIDOCAINE 5%Little Pharma, Inc.f20241a2-c5b1-f124-e053-2995a90a891b2025-06-16WarningsExact identifier
application number: M017
Toast Screamin MentholMENTHOLIDEAZ, LLC37b48b1a-ef3d-afdc-e063-6294a90a66102025-06-16WarningsExact identifier
application number: M017
Toast Freezin ColdMENTHOL, METHYL SALICYLATEIDEAZ, LLC37b4d363-0099-8cd3-e063-6394a90a18d62025-06-16WarningsExact identifier
application number: M017
Earths Care Anti-ItchCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.ba65f58a-d590-498a-b8e7-a3d78935d8802025-06-13WarningsExact identifier
application number: M017
LidocaineLIDOCAINEStratus Pharmaceuticals Inc5eb6574c-2066-4390-befc-8e5d2dd6ede22025-06-12WarningsExact identifier
application number: M017
CHINESE RED TIGER LIDOCAINE PATCHES4% LIDOCAINE, 1%MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36b9a7a2-5832-4ce5-e063-6294a90aed122025-06-12WarningsExact identifier
application number: M017
PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd375bc794-3289-e610-e063-6294a90a4f9b2025-06-12WarningsExact identifier
application number: M017
Methyl Salicylate 10% Pain RelievingMETHYL SALICYLATEPureTek Corporation376493eb-5142-db6d-e063-6294a90a1e732025-06-12WarningsExact identifier
application number: M017
Free and Pure Cold Therapy Pain ReliefMENTHOLWalgreen Co.22cbbffc-f876-411e-e063-6394a90a1b382025-06-12WarningsExact identifier
application number: M017
Methylten 25% Pain RelievingMETHYL SALICYLATEPureTek Corporation3767b97e-ab0c-ac26-e063-6394a90a00cf2025-06-12WarningsExact identifier
application number: M017
SPF 50 Mineral SunscreenZINC OXIDEInspec Solutions, LLC36af9a0a-536b-ee1a-e063-6394a90aace42025-06-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN30c97646-db06-df84-e063-6394a90a77431
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN0976a898-8d79-4b85-b473-c8ad32b4fd001
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN2b4d2105-b7ad-2695-e063-6394a90a999b1
2675625LidoPro Pain Relieving Patch 4 % / 1 % Medicated PatchPSN0976a898-8d79-4b85-b473-c8ad32b4fd001
2675625LidoPro Pain Relieving Patch 4 % / 1 % Medicated PatchPSN2b4d2105-b7ad-2695-e063-6394a90a999b1
2675625LidoPro Pain Relieving Patch 4 % / 1 % Medicated PatchPSN30c97646-db06-df84-e063-6394a90a77431
2675625lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [LidoPro Pain Relieving Patch]SBD30c97646-db06-df84-e063-6394a90a77431
2675625lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [LidoPro Pain Relieving Patch]SBD0976a898-8d79-4b85-b473-c8ad32b4fd001
2675625lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [LidoPro Pain Relieving Patch]SBD2b4d2105-b7ad-2695-e063-6394a90a999b1
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD2b4d2105-b7ad-2695-e063-6394a90a999b1
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD30c97646-db06-df84-e063-6394a90a77431
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD0976a898-8d79-4b85-b473-c8ad32b4fd001
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY2b4d2105-b7ad-2695-e063-6394a90a999b1
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY30c97646-db06-df84-e063-6394a90a77431
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY0976a898-8d79-4b85-b473-c8ad32b4fd001
2675625LidoPro Pain Relieving Patch (lidocaine 4 % / menthol 1 % ) Medicated PatchSY30c97646-db06-df84-e063-6394a90a77431
2675625LidoPro Pain Relieving Patch (lidocaine 4 % / menthol 1 % ) Medicated PatchSY2b4d2105-b7ad-2695-e063-6394a90a999b1
2675625LidoPro Pain Relieving Patch (lidocaine 4 % / menthol 1 % ) Medicated PatchSY0976a898-8d79-4b85-b473-c8ad32b4fd001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83881-402-05838810402055 mg in 1 POUCH (83881-402-05) 5 mg2025-01-09NoNoCurrent
83881-402-158388104021515 mg in 1 POUCH (83881-402-15) 15 mg2025-01-09NoNoCurrent