Terocin

Product NDC
50436-9995
11-digit product format
504369995
Labeler code
50436
Product ID
50436-9995_08c55b04-4e94-4866-9e22-46f116b2eb52
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Capsaicin, Menthol and Lidocaine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Unit Dose Services
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-10-01
Marketing end
0000-00-00
Substance
METHYL SALICYLATE; CAPSAICIN; MENTHOL; LIDOCAINE HYDROCHLORIDE
Active strength
25 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct50436-9995IInactivated by FDA2026-10-05
excluded packagepackage50436-999550436-9995-1IInactivated 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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-9995-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-9995-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-9995-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-9995-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-9995-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-9995-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-9995-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-9995-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-9995-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-9995-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-9995-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-9995-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-9995-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-9995-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-9995-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-9995-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-9995-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-9995-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-9995-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50436-9995-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50436-9995-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50436-9995-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-9995-12020-01-31C16284748780-19d75b9d0-6778-f424-e053-dadaa90a57ceTerocin Topical Pain Relief Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-9995-1Terocin120 mL in 1 BOTTLELOTION1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-9995-1ML - Milliliter50436-9995f11662cd-1f48-404e-83c8-b14a4b634ac312013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ATEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
MENTHOLACTIVE INGREDIENTL7T10EIP3ATEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
CAPSAICINACTIVE MOIETYS07O44R1ZMTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
LIDOCAINEACTIVE MOIETY98PI200987TEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
MENTHOLACTIVE MOIETYL7T10EIP3ATEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
BORAGE OILINACTIVE INGREDIENTF8XAG1755STEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4TEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2MTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0RTEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9995TEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20130211_b24f5cfc-7957-4f65-9968-cf1084e69128.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020420capsaicin 0.025 % / lidocaine HCl 2.5 % / menthol 10 % / methyl salicylate 25 % Topical LotionPSNb24f5cfc-7957-4f65-9968-cf1084e691282
1020420capsaicin 0.25 MG/ML / lidocaine hydrochloride 25 MG/ML / menthol 100 MG/ML / methyl salicylate 250 MG/ML Topical LotionSCDb24f5cfc-7957-4f65-9968-cf1084e691282
1020420capsaicin 0.025 % / lidocaine HCl 2.5 % / menthol 10 % / methyl salicylate 25 % Topical LotionSYb24f5cfc-7957-4f65-9968-cf1084e691282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-9995-150436999501120 mL in 1 BOTTLE120 mlHistorical