FDA.reportPublic FDA data

New Terocin

Manufacturer
A-S Medication Solutions
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 00:51:26

Label at a glance#

ProductNEW TEROCIN
Active ingredientMETHYL SALICYLATE, CAPSAICIN, MENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves mild aches and pains of muscles or joints.

Dosage and administration

Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately afterwards to avoid contact with eyes.

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25%
Capsaicin 0.025%
Menthol 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves mild aches and pains of muscles or joints.

Warnings

WARNINGS SECTION

Only for external use.

Do Not Use:

OTC - DO NOT USE SECTION

on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.

Consult your physician:

OTC - ASK DOCTOR SECTION

if pain is persistent or worsens or if using any other topical pain products.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Consult physician for children under 12.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately afterwards to avoid contact with eyes.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Borago Officinalis (Borage) Seed Oil, Boswellia Serrata Extract, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetyl Alcohol, Diazolidinyl Urea, Dimethyl Sulfone (DMSO), DMDM Hydantoin, Glyceryl Stearate, Lavandula Angustifolia (Lavender) Oil, Methyl Paraben, PEG-100 Stearate, Polysorbate-20, Polysorbate-60, Propyl Paraben, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1353

NDC: 50090-1353-0 120 mL in a BOTTLE

Methyl Salicylate, Capsaicin, and Menthol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372464capsaicin 0.025 % / menthol 10 % / methyl salicylate 25 % Topical LotionPSN16
1372464capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 250 MG/ML Topical LotionSCD16
1372464capsaicin 0.025 % / menthol 10 % / methyl salicylate 25 % Topical LotionSY16

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1353-02023-02-07C16284748780-1f386c64a-304c-0266-e053-dadaa90a7c1aNEW TEROCIN
50090-1353-02023-01-30C16284748780-1f386c64a-304c-0266-e053-dadaa90a7c1aNEW TEROCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1353-0NEW TEROCIN120 mL in 1 BOTTLELOTION12016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1353NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 1 package rows20250110_43e5eb27-5541-4b7b-80de-55a79a4dce55.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1353-0ML - Milliliter50090-1353db113400-a090-4ffa-b9c0-3312f354183212018-11-06
50488-1129-1ML - Milliliter50488-112951b71bfc-6b6f-4000-8de7-a606a38d26a212013-04-01

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-135350090-1353-0
50488-1129

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
CAPSAICINS07O44R1ZMACTIB
MENTHOLL7T10EIP3AACTIB
ALOE BARBADENSIS LEAF JUICEZY81Z83H0XIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 60CAL22UVI4MIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILZBP1YXW0H8IACT
BORAGE OILF8XAG1755SIACT
BOSWELLIA SERRATA GUM4PW41QCO2MIACT
XANTHAN GUMTTV12P4NEEIACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DMDM HYDANTOINBYR0546TOWIACT
STEARYL ALCOHOL2KR89I4H1YIACT

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
ndc (package): 50090-1353-0
ndc (product): 50090-1353
ndc11 (package): 50090135300
spl id: 985dca22-0968-4d40-a331-a1dbf032bf6b
spl set id: 43e5eb27-5541-4b7b-80de-55a79a4dce55
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
ndc (product): 50488-1129

Reported adverse events (FAERS/openFDA)#

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