FDA.reportPublic FDA data

LidoPro Patch

Product NDC
53225-1023
11-digit product format
532251023
Labeler code
53225
Product ID
53225-1023_eea4acef-fa68-1e58-e053-2995a90ad386
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol, and Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Terrain Pharmaceuticals
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-12-02
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE
Active strength
4 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
2023-12-31
Current FDA listing
Historical FDA.report record

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53225-1023-1EA - Each53225-10236dfc0115-b29a-434b-9b93-43e74a3ad4d712015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ALIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ALIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
2-ETHYLHEXYL ACRYLATEINACTIVE INGREDIENTHR49R9S6XGLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
ACRYLIC ACIDINACTIVE INGREDIENTJ94PBK7X8SLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0LIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
METHYL ACRYLATEINACTIVE INGREDIENTWC487PR91HLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
NONOXYNOL-30INACTIVE INGREDIENTJJX07DG188LIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6WLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341LLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ALIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOPRO PATCH (LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) PATCH [PREFERRED PHARMACEUTICALS INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599164lidocaine 4 % / menthol 5 % / methyl salicylate 4 % Medicated PatchPSN2791c44a-61de-45c8-9af7-50396bed09295
1599302LidoPro Patch 4 % / 5 % / 4 % Medicated PatchPSN2791c44a-61de-45c8-9af7-50396bed09295
1599302lidocaine 0.04 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.04 MG/MG Medicated Patch [LidoPro Patch]SBD2791c44a-61de-45c8-9af7-50396bed09295
1599164lidocaine 0.04 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.04 MG/MG Medicated PatchSCD2791c44a-61de-45c8-9af7-50396bed09295
1599164lidocaine 4 % / menthol 5 % / methyl salicylate 4 % Medicated PatchSY2791c44a-61de-45c8-9af7-50396bed09295
1599302LidoPro Patch (lidocaine 4 % / menthol 5 % / methyl salicylate 4 % ) Medicated PatchSY2791c44a-61de-45c8-9af7-50396bed09295
1599164lidocaine 4 % / menthol 5 % / methyl salicylate 4 % Medicated PatchPSN142e5b26-ca69-4546-b43d-88fb0e0bb3852
1599302LidoPro Patch 4 % / 5 % / 4 % Medicated PatchPSN142e5b26-ca69-4546-b43d-88fb0e0bb3852
1599302lidocaine 0.04 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.04 MG/MG Medicated Patch [LidoPro Patch]SBD142e5b26-ca69-4546-b43d-88fb0e0bb3852
1599164lidocaine 0.04 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.04 MG/MG Medicated PatchSCD142e5b26-ca69-4546-b43d-88fb0e0bb3852
1599164lidocaine 4 % / menthol 5 % / methyl salicylate 4 % Medicated PatchSY142e5b26-ca69-4546-b43d-88fb0e0bb3852
1599302LidoPro Patch (lidocaine 4 % / menthol 5 % / methyl salicylate 4 % ) Medicated PatchSY142e5b26-ca69-4546-b43d-88fb0e0bb3852
1599164lidocaine 4 % / menthol 5 % / methyl salicylate 4 % Medicated PatchPSN7d64bbdc-f965-5427-e053-2991aa0a463f1
1599302LidoPro Patch 4 % / 5 % / 4 % Medicated PatchPSN7d64bbdc-f965-5427-e053-2991aa0a463f1
1599302lidocaine 0.04 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.04 MG/MG Medicated Patch [LidoPro Patch]SBD7d64bbdc-f965-5427-e053-2991aa0a463f1
1599164lidocaine 0.04 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.04 MG/MG Medicated PatchSCD7d64bbdc-f965-5427-e053-2991aa0a463f1
1599164lidocaine 4 % / menthol 5 % / methyl salicylate 4 % Medicated PatchSY7d64bbdc-f965-5427-e053-2991aa0a463f1
1599302LidoPro Patch (lidocaine 4 % / menthol 5 % / methyl salicylate 4 % ) Medicated PatchSY7d64bbdc-f965-5427-e053-2991aa0a463f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53225-1023-15322510230115 POUCH in 1 BOX (53225-1023-1) > 5 PATCH in 1 POUCH > 8500 mg in 1 PATCH15 pouch2014-12-020000-00-00NoNoCurrent