FDA.reportPublic FDA data

Terocin

Product NDC
68788-9555
Requested package NDC
68788-9555-1
11-digit product format
687889555
Labeler code
68788
Product ID
68788-9555_0226957b-186b-4337-8aa4-d50b6061d86a
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
part348
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-23
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
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
Terocin
Listing expiration
2027-12-31

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
23843354-e242-4a8a-8818-897592d4d9a0Available 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
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
68788-9555-1Terocin5 in 1 POUCHPATCH510
68788-9555-1Terocin2 in 1 BOXPATCH210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-9555-1EA - Each68788-95559dc7a176-f5c8-4793-9ff7-65cab8ce9ced12018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
68788-9555TEROCIN (LIDOCAINE, MENTHOL) PATCH [PREFERRED PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20240821_23843354-e242-4a8a-8818-897592d4d9a0.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9555-1687889555012 POUCH in 1 BOX (68788-9555-1) / 5 PATCH in 1 POUCH2 pouch2013-09-230000-00-00NoNoCurrent