FDA.reportPublic FDA data

METHYL SALICYLATE 25%

Manufacturer
Oncora Pharma, LLC
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:34

Label at a glance#

ProductMETHYL SALICYLATE 25%
Active ingredientMETHYL SALICYLATE
Label structure12 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simpled backache, arthritis, strains, bruises and sprains.

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints, associated with simpled backache, arthritis, strains, bruises and sprains.

WARNINGS SECTION

For external use only.

Do not used on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with the eyes
  • Do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash or irritation develops and lasts
  • condition worsens
  • if symptoms persist more than 7 days or clear up and occur again in a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age, consult a doctor.

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25%

INACTIVE INGREDIENT SECTION

Arnica Montana Extract, Cetearly Alcohol, Dimethyl Sulfone, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Silica, Sodium Chondroitin Sulfate, Sodium Polyacrylate, Stearic Acid, Triethanolamine, Water

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238542methyl salicylate 25 % Topical CreamPSN1
238542methyl salicylate 250 MG/ML Topical CreamSCD1
238542methyl salicylate 25 % Topical CreamSY1

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
85477-311-10METHYL SALICYLATE 25%120 g in 1 TUBECREAM1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-311-10GM - Gram85477-3113ba9d061-4b45-4a52-b329-ecfc311bb73112025-09-12

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-31185477-311-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERYL STEARATE230OU9XXE4IACT
STEARIC ACID4ELV7Z65APIACT
TRIETHANOLAMINE9O3K93S3TKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ARNICA MONTANAO80TY208ZWIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)H5BJH23Z9AIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
PEG-100 STEARATEYD01N1999RIACT
METHYL SALICYLATELAV5U5022YACTIB
CETEARYL ALCOHOL2DMT128M1SIACT
ISOSTEARYL PALMITATE9EHU0R7ER1IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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%METHYL SALICYLATEOncora Pharma, LLC3c4bc55d-6582-3b5e-e063-6394a90a994c2025-08-13WarningsExact identifier
ndc (package): 85477-311-10
ndc (product): 85477-311
ndc11 (package): 85477031110
spl id: 3c4bc55d-6581-3b5e-e063-6394a90a994c
spl set id: 3c4bc55d-6582-3b5e-e063-6394a90a994c

Reported adverse events (FAERS/openFDA)#

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