FDA.reportPublic FDA data

Methyl Salicylate 25% Cream

Manufacturer
Medcore LLC
Effective date
2025-07-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:07:30

Label at a glance#

ProductMethyl Salicylate 25% Cream
Active ingredientMETHYL SALICYLATE
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Dosage and administration

adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day children under 2 years ask a doctor

Storage and handling

- May be applied under occlusive dressing. - Store at 20-25-C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Label contents#

Full prescribing information#

​

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Warnings

WARNINGS SECTION

​For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes
  • Do not use in larger quantities, particularly over raw surfaces or blistered areas
  • Do not apply to wounds or damaged skin
  • Do not bandage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day
children under 2 yearsask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • May be applied under occlusive dressing.
  • Store at 20-25-C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerine, CETOSTEARYLALCOHOL, ETHYLHEXYLGLYCERIN, GLUCOSAMINE SULFATE, CHONDROITIN SULFATE, (BOVINE), GLYCERYL MONOSTEARATE, C13-14ISOPARAFFIN, ISOSTEARYL PALMITATE, TROLAMINE, STEARIC ACID, PROPYLENE GLYCOL, LAURETH-7, PEG-100 STEARATE, Water, PHENOXYETHANOL.

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82461-415-10

Medcore LLC

Methyl Salicylate 25% Cream

120mL

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

Label-1Label-1

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82461-415-05

Medcore LLC

Methyl Salicylate 25% Cream

50mL

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

Label-2Label-2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238542methyl salicylate 25 % Topical CreamPSN2
238542methyl salicylate 250 MG/ML Topical CreamSCD2
238542methyl salicylate 25 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82461-415-05Methyl Salicylate 25% Cream50 mL in 1 BOTTLE, PUMPCREAM502
82461-415-10Methyl Salicylate 25% Cream120 mL in 1 BOTTLE, PUMPCREAM1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82461-415-05ML - Milliliter82461-41582dc9940-0532-41c9-acc6-86195af5cdce12025-09-12
82461-415-10ML - Milliliter82461-41539f848f2-a71f-48c0-8cae-5112e9bc143f12025-03-04

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82461-41582461-415-10, 82461-415-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOSTEARYL PALMITATE9EHU0R7ER1IACT
TROLAMINE9O3K93S3TKIACT
STEARIC ACID4ELV7Z65APIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LAURETH-7Z95S6G8201IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methyl Salicylate 25% CreamMETHYL SALICYLATEMedcore LLC143f76bf-2de4-466a-8a6b-d6ab6314a2c32025-07-14WarningsExact identifier
ndc (package): 82461-415-10
ndc (package): 82461-415-05
ndc (product): 82461-415
ndc11 (package): 82461041510
ndc11 (package): 82461041505
spl id: 2dddf0c3-d666-41b7-9155-64034f7bf54f
spl set id: 143f76bf-2de4-466a-8a6b-d6ab6314a2c3

Reported adverse events (FAERS/openFDA)#

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