FDA.reportPublic FDA data

Terocin

Product NDC
50488-1001
11-digit product format
504881001
Labeler code
50488
Product ID
50488-1001_f09407bf-797e-41a6-a21a-de93183af2ea
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Alexso, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-01
Substance
LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
600; 600 mg/1; mg/1
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
Terocin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE600 mg/1
MENTHOL, UNSPECIFIED FORM600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, L7T10EIP3A
Rxcui1428948

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
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
50488-1001-1Terocin2 in 1 BOXPATCH26
50488-1001-1Terocin5 in 1 POUCHPATCH56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1001-1EA - Each50488-1001ee8e93c8-555b-43a2-b4b0-b07e6026efed12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987TEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
MENTHOLACTIVE INGREDIENTL7T10EIP3ATEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987TEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3ATEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4TEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBTEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
LEMON OILINACTIVE INGREDIENTI9GRO824LLTEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JTEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RTEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC.]2
LIDOCAINEACTIVE INGREDIENT98PI200987TEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ATEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987TEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ATEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4TEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
LEMON OILINACTIVE INGREDIENTI9GRO824LLTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1001TEROCIN (LIDOCAINE, MENTHOL) PATCH [ALEXSO, INC]6Current NDC, Legacy NDC, 2 package rows20241208_100ceb76-8ebe-437b-a8de-37cc76ece9bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1428948lidocaine 4 % / menthol 4 % Medicated PatchPSN23843354-e242-4a8a-8818-897592d4d9a010
1428948lidocaine 0.04 MG/MG / menthol 0.04 MG/MG Medicated PatchSCD23843354-e242-4a8a-8818-897592d4d9a010
1428948lidocaine 4 % / menthol 4 % Medicated PatchSY23843354-e242-4a8a-8818-897592d4d9a010
1428948lidocaine 4 % / menthol 4 % Medicated PatchPSN100ceb76-8ebe-437b-a8de-37cc76ece9bb6
1428948lidocaine 0.04 MG/MG / menthol 0.04 MG/MG Medicated PatchSCD100ceb76-8ebe-437b-a8de-37cc76ece9bb6
1428948lidocaine 4 % / menthol 4 % Medicated PatchSY100ceb76-8ebe-437b-a8de-37cc76ece9bb6
1428948lidocaine 4 % / menthol 4 % Medicated PatchPSN29359d88-b732-45ff-9275-537ddcfa78323
1428948lidocaine 0.04 MG/MG / menthol 0.04 MG/MG Medicated PatchSCD29359d88-b732-45ff-9275-537ddcfa78323
1428948lidocaine 4 % / menthol 4 % Medicated PatchSY29359d88-b732-45ff-9275-537ddcfa78323
1428948lidocaine 4 % / menthol 4 % Medicated PatchPSN449ff436-a7d0-4f19-99af-4aa485a7f0741
1428948lidocaine 4 % / menthol 4 % Medicated PatchPSN87335361-95fb-0a2d-e053-2a91aa0a64ff1
1428948lidocaine 4 % / menthol 4 % Medicated PatchPSNcc0803a5-5d9d-41fe-b67f-ed0bd7eca25e1
1428948lidocaine 0.04 MG/MG / menthol 0.04 MG/MG Medicated PatchSCD449ff436-a7d0-4f19-99af-4aa485a7f0741
1428948lidocaine 0.04 MG/MG / menthol 0.04 MG/MG Medicated PatchSCDcc0803a5-5d9d-41fe-b67f-ed0bd7eca25e1
1428948lidocaine 0.04 MG/MG / menthol 0.04 MG/MG Medicated PatchSCD87335361-95fb-0a2d-e053-2a91aa0a64ff1
1428948lidocaine 4 % / menthol 4 % Medicated PatchSYcc0803a5-5d9d-41fe-b67f-ed0bd7eca25e1
1428948lidocaine 4 % / menthol 4 % Medicated PatchSY87335361-95fb-0a2d-e053-2a91aa0a64ff1
1428948lidocaine 4 % / menthol 4 % Medicated PatchSY449ff436-a7d0-4f19-99af-4aa485a7f0741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50488-1001-1504881001012 POUCH in 1 BOX (50488-1001-1) / 5 PATCH in 1 POUCH2 pouch2013-05-010000-00-00NoNoCurrent