FDA.reportPublic FDA data

Eagle Brand

Product NDC
60954-020
11-digit product format
609540020
Labeler code
60954
Product ID
60954-020_50805eee-33b4-86bd-e063-6294a90a77d8
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, methyl salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
PT. EAGLE INDO PHARMA
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-01
Substance
METHYL SALICYLATE; MENTHOL
Active strength
30; 14.5 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Eagle Brand
Brand name suffix
Medicated Roll On
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE30 g/100mL
MENTHOL14.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293430Internal RxNorm lookup
1293435Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50805eee-33b3-86bd-e063-6294a90a77d8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-020-08Eagle BrandMedicated Roll On1 in 1 BOXOIL11
60954-020-08Eagle BrandMedicated Roll On8 mL in 1 BOTTLE, GLASSOIL81

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 89 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aloe Up SPF 50 MineralZINC OXIDEAloe International, LLC35bc3621-f4e4-42d3-e063-6394a90a7aad2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDEAloe International, LLC35cd5542-947d-a042-e063-6394a90a13f82025-06-18WarningsExact identifier
application number: M017
Relieve Your PainMENTHOLProximity Capital Partners LLC dba Asutrac12369dd-8305-edaf-e053-2995a90a0d3d2025-06-18WarningsExact identifier
application number: M017
Melt Pain AwayCAPSAICINProximity Capital Partners LLC dba Asutraa95a11d7-a2ae-6654-e053-2a95a90a802c2025-06-18WarningsExact identifier
application number: M017
Recovery Roll-OnMENTHOL, CAMPHORPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRAebc9630f-6d8b-e4f0-e053-2995a90a0b492025-06-18WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37cdfabc-1fdb-246a-e063-6394a90a008a2025-06-17WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37ce6c35-b211-43de-e063-6294a90ab7732025-06-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Sun Pharmaceutical Industries, Inc.312ddc8d-100e-cfac-e063-6294a90acd092025-06-16WarningsExact identifier
application number: M017
Curist 5% LidocaineLIDOCAINE 5%Little Pharma, Inc.f20241a2-c5b1-f124-e053-2995a90a891b2025-06-16WarningsExact identifier
application number: M017
Toast Screamin MentholMENTHOLIDEAZ, LLC37b48b1a-ef3d-afdc-e063-6294a90a66102025-06-16WarningsExact identifier
application number: M017
Toast Freezin ColdMENTHOL, METHYL SALICYLATEIDEAZ, LLC37b4d363-0099-8cd3-e063-6394a90a18d62025-06-16WarningsExact identifier
application number: M017
Earths Care Anti-ItchCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.ba65f58a-d590-498a-b8e7-a3d78935d8802025-06-13WarningsExact identifier
application number: M017
LidocaineLIDOCAINEStratus Pharmaceuticals Inc5eb6574c-2066-4390-befc-8e5d2dd6ede22025-06-12WarningsExact identifier
application number: M017
CHINESE RED TIGER LIDOCAINE PATCHES4% LIDOCAINE, 1%MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36b9a7a2-5832-4ce5-e063-6294a90aed122025-06-12WarningsExact identifier
application number: M017
PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd375bc794-3289-e610-e063-6294a90a4f9b2025-06-12WarningsExact identifier
application number: M017
Methyl Salicylate 10% Pain RelievingMETHYL SALICYLATEPureTek Corporation376493eb-5142-db6d-e063-6294a90a1e732025-06-12WarningsExact identifier
application number: M017
Free and Pure Cold Therapy Pain ReliefMENTHOLWalgreen Co.22cbbffc-f876-411e-e063-6394a90a1b382025-06-12WarningsExact identifier
application number: M017
Methylten 25% Pain RelievingMETHYL SALICYLATEPureTek Corporation3767b97e-ab0c-ac26-e063-6394a90a00cf2025-06-12WarningsExact identifier
application number: M017
SPF 50 Mineral SunscreenZINC OXIDEInspec Solutions, LLC36af9a0a-536b-ee1a-e063-6394a90aace42025-06-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSN50805eee-33b3-86bd-e063-6294a90a77d81
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSN50805eee-33b3-86bd-e063-6294a90a77d81
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBD50805eee-33b3-86bd-e063-6294a90a77d81
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCD50805eee-33b3-86bd-e063-6294a90a77d81
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSY50805eee-33b3-86bd-e063-6294a90a77d81
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSY50805eee-33b3-86bd-e063-6294a90a77d81
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSY50805eee-33b3-86bd-e063-6294a90a77d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60954-020-08609540020081 BOTTLE, GLASS in 1 BOX (60954-020-08) / 8 mL in 1 BOTTLE, GLASS2026-04-01NoNoCurrent