FDA.reportPublic FDA data

LidoPro Patch

Product NDC
83881-401
11-digit product format
838810401
Labeler code
83881
Product ID
83881-401_13681f7a-d4a8-ecbb-e063-6294a90ad66d
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol, and Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Clinic Pharma
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-09
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

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 Identifiers#

Field, Values table
FieldValues
Unii98PI200987, L7T10EIP3A, LAV5U5022Y
Rxcui2675022, 2675024

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
83881-401-02LidoPro Patch8500 mg in 1 PATCHPATCH85002
83881-401-02LidoPro Patch2 in 1 POUCHPATCH22
83881-401-30LidoPro Patch15 in 1 BOXPATCH152
83881-401-30LidoPro Patch2 in 1 POUCHPATCH22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83881-401-02EA - Each83881-40120e2a9b0-fe4b-45f1-a9b5-8f84d6bc947412024-03-12
83881-401-30EA - Each83881-4019e9eafdc-4319-405e-8a30-51cde6f0acea12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83881-401LIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [CLINIC PHARMA]2Current NDC, 4 package rows20240312_10f98011-bffc-cc56-e063-6394a90a0116.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675022lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % Medicated PatchPSN6c9a076e-6316-427b-9ce6-c8fe2d3888373
2675024LidoPro Patch 4 % / 0.5 % / 0.1 % Medicated PatchPSN6c9a076e-6316-427b-9ce6-c8fe2d3888373
2675024lidocaine 0.04 MG/MG / menthol 0.005 MG/MG / methyl salicylate 0.001 MG/MG Medicated Patch [LidoPro Patch]SBD6c9a076e-6316-427b-9ce6-c8fe2d3888373
2675022lidocaine 0.04 MG/MG / menthol 0.005 MG/MG / methyl salicylate 0.001 MG/MG Medicated PatchSCD6c9a076e-6316-427b-9ce6-c8fe2d3888373
2675022lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % Medicated PatchSY6c9a076e-6316-427b-9ce6-c8fe2d3888373
2675024LidoPro Patch (lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % ) Medicated PatchSY6c9a076e-6316-427b-9ce6-c8fe2d3888373
2675022lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % Medicated PatchPSN10f98011-bffc-cc56-e063-6394a90a01162
2675024LidoPro Patch 4 % / 0.5 % / 0.1 % Medicated PatchPSN10f98011-bffc-cc56-e063-6394a90a01162
2675024lidocaine 0.04 MG/MG / menthol 0.005 MG/MG / methyl salicylate 0.001 MG/MG Medicated Patch [LidoPro Patch]SBD10f98011-bffc-cc56-e063-6394a90a01162
2675022lidocaine 0.04 MG/MG / menthol 0.005 MG/MG / methyl salicylate 0.001 MG/MG Medicated PatchSCD10f98011-bffc-cc56-e063-6394a90a01162
2675022lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % Medicated PatchSY10f98011-bffc-cc56-e063-6394a90a01162
2675024LidoPro Patch (lidocaine 4 % / menthol 0.5 % / methyl salicylate 0.1 % ) Medicated PatchSY10f98011-bffc-cc56-e063-6394a90a01162
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
83881-401-02838810401022 PATCH in 1 POUCH (83881-401-02) / 8500 mg in 1 PATCH2 patch2024-02-09NoNoCurrent
83881-401-308388104013015 POUCH in 1 BOX (83881-401-30) / 2 PATCH in 1 POUCH / 8500 mg in 1 PATCH15 pouch2024-02-09NoNoCurrent