FDA.reportPublic FDA data

New Terocin

Product NDC
68788-7821
11-digit product format
687887821
Labeler code
68788
Product ID
68788-7821_805ae929-c59a-46ab-b2da-ea1586dec0e6
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Capsaicin, and Menthol
Dosage form
LOTION
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
part348
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-16
Substance
CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
.025; 10; 25 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
New Terocin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE.025 g/100mL
CAPSAICIN10 g/100mL
MENTHOL, UNSPECIFIED FORM25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLAV5U5022Y, S07O44R1ZM, L7T10EIP3A
Rxcui1372464

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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7821-12022-10-11C16284748780-1d6a99b39-ff2d-a426-e053-dadaa90af4c2New Terocin Topical Pain Relief Lotion
68788-7821-12022-01-28C16284748780-1d6a99b39-ff2d-a426-e053-dadaa90af4c2New Terocin Topical Pain Relief Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7821-1New Terocin120 mL in 1 BOTTLELOTION1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7821-1ML - Milliliter68788-7821ee8eff17-7ed8-4089-a29b-48b98891545712021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7821NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 1 package rows20240821_186445d4-ef73-4d34-849d-4661a3eaa43a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372464capsaicin 0.025 % / menthol 10 % / methyl salicylate 25 % Topical LotionPSN186445d4-ef73-4d34-849d-4661a3eaa43a5
1372464capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 250 MG/ML Topical LotionSCD186445d4-ef73-4d34-849d-4661a3eaa43a5
1372464capsaicin 0.025 % / menthol 10 % / methyl salicylate 25 % Topical LotionSY186445d4-ef73-4d34-849d-4661a3eaa43a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7821-168788782101120 mL in 1 BOTTLE (68788-7821-1) 120 ml2020-11-160000-00-00NoNoCurrent