New Terocin

Product NDC
68258-3981
11-digit product format
682583981
Labeler code
68258
Product ID
68258-3981_2ea41ae0-8f33-4902-bff1-606437d1da9c
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Capsaicin, and Menthol
Dosage form
LOTION
Route
TOPICAL
Labeler
Dispensing Solutions, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-03-13
Marketing end
0000-00-00
Substance
METHYL SALICYLATE; CAPSAICIN; MENTHOL
Active strength
25 g/100mL; g/100mL; g/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68258-3981IInactivated by FDA2026-10-05
excluded packagepackage68258-398168258-3981-4IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68258-3981-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68258-3981-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68258-3981-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68258-3981-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68258-3981-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68258-3981-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68258-3981-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68258-3981-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68258-3981-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68258-3981-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68258-3981-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68258-3981-4557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68258-3981-48af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68258-3981-4834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68258-3981-41332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68258-3981-4fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68258-3981-486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68258-3981-4bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68258-3981-48dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68258-3981-4e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68258-3981-49bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68258-3981-4110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
68258-3981-42019-11-27C16284748780-19855d018-e291-cd31-e053-dbdaa90ab51aNew Terocin Topical Pain Relief Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3981-4New Terocin120 mL in 1 BOTTLELOTION1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68258-3981-4ML - Milliliter68258-39817fbe8866-9e45-4fd1-9c00-2b7cee0282fe12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ANEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
CAPSAICINACTIVE MOIETYS07O44R1ZMNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ANEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
BORAGE OILINACTIVE INGREDIENTF8XAG1755SNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2MNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
LIDOCAINEINACTIVE INGREDIENT98PI200987NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3981NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20130618_1dd035b2-4495-4fa5-8086-bb6184eeec05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372464capsaicin 0.025 % / menthol 10 % / methyl salicylate 25 % Topical LotionPSN1dd035b2-4495-4fa5-8086-bb6184eeec051
1372464capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 250 MG/ML Topical LotionSCD1dd035b2-4495-4fa5-8086-bb6184eeec051
1372464capsaicin 0.025 % / menthol 10 % / methyl salicylate 25 % Topical LotionSY1dd035b2-4495-4fa5-8086-bb6184eeec051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68258-3981-468258398104120 mL in 1 BOTTLE120 mlHistorical