Methyl Salicylate 40% Topical Oil

Manufacturer
FORREAL PHARMACEUTICALS LLC
Effective date
2025-10-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:38:03

Label at a glance#

ProductMethyl Salicylate 40% Topical Oil
Active ingredientMETHYL SALICYLATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: Methyl Salicylate 40%

OTC - PURPOSE SECTION

Purpose: Topical Analgesic

INDICATIONS & USAGE SECTION

Uses: Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, sprains, bruises.

WARNINGS SECTION

Warning: For external use only. DO NOT USE IF ALLERGIC TO PEANUTS

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate or peanuts.

OTC - WHEN USING SECTION

When using the product: Do not use in or near the eyes or mucous membranes; if the product gets into the eyes, rinse thoroughly with cold water. Do not bandage tightly or use with hot pads.

OTC - STOP USE SECTION

Stop use and ask doctor if symptoms last more than 7 days or clear up and occur again within a few days. Or condition worsens or rash or irritation develops.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. if swallowed, get medical help or contract a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults and children 12 years of age and older; apply generously to affected area. Massage vigorously into painful areas until absorbed completely. Repeat as needed, but do not use more than three times daily. Children under 12 years of age, ask a doctor.
Other information: Store at room tempreature. Protect from light and heat. Close cap tightly after use.

INACTIVE INGREDIENT SECTION

Inactive ingredient: Peanut Oil.

Packaged For:
Forreal Pharmaceuticals LLC
Royal Oak, MI 48067

Question or Comments please call 877-367-3250

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 81877-620-04            4 Fluid oz. (118 ml)

Methyl
Salicylate 40%

Topical Rubbing Oil

For Temporary Relief of Minor Pains.

DO NOT USE IF ALLERGIC TO PEANUTS

Forreal Pharmaceuticals LLC
YOUR SOLUTION TO BETTER HEALTHCARE

Methyl Salicylate 40%Methyl Salicylate 40%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259328methyl salicylate 40 % Topical OilPSN4
259328methyl salicylate 400 MG/ML Topical OilSCD4
259328methyl salicylate 40 % Topical OilSY4

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81877-620-042024-07-30C16284748780-11e7a6dab-18bc-a2ce-e063-dadaa90aadf710e15734-9783-4153-b7b6-a4d0f57678b6
81877-620-042024-07-30C16284748780-11e7a6dab-18bc-a2ce-e063-dadaa90aadf710e15734-9783-4153-b7b6-a4d0f57678b6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81877-620-04Methyl Salicylate 40% Topical Oil118 mL in 1 BOTTLE, GLASSLIQUID1184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81877-620-04ML - Milliliter81877-62023e57b55-6165-4950-8d78-346c123b4f9212023-06-06

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81877-62081877-620-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEANUT OIL5TL50QU0W4IACT
METHYL SALICYLATELAV5U5022YACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32023-05-10full-release2026-05-31 23:54:54

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 40% Topical OilMETHYL SALICYLATEFORREAL PHARMACEUTICALS LLC10e15734-9783-4153-b7b6-a4d0f57678b62025-10-07WarningsExact identifier
ndc (package): 81877-620-04
ndc (product): 81877-620
ndc11 (package): 81877062004
spl id: 4fc1c01f-5af7-4676-804b-fab4443daba9
spl set id: 10e15734-9783-4153-b7b6-a4d0f57678b6

Reported adverse events (FAERS/openFDA)#

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