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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1428948Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
100ceb76-8ebe-437b-a8de-37cc76ece9bbAvailable 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
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
LIDOCAINEACTIVE INGREDIENT98PI200987TEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ATEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ATEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LIDOCAINEACTIVE MOIETY98PI200987TEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LIDOCAINEACTIVE MOIETY98PI200987TEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ATEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ATEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4TEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4TEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBTEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LEMON OILINACTIVE INGREDIENTI9GRO824LLTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
LEMON OILINACTIVE INGREDIENTI9GRO824LLTEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JTEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JTEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTEROCIN (LIDOCAINE, MENTHOL) PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerocinLIDOCAINE, MENTHOLAlexso, Inc100ceb76-8ebe-437b-a8de-37cc76ece9bb2024-12-09WarningsExact identifier
ndc (product): 50488-1001

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