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 37 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC498cd2aa-ee59-67b5-e063-6294a90ac2422026-01-29WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORSUNSET NOVELTIES, INC498d76d8-788b-4cc7-e063-6294a90a16962026-01-29WarningsExact identifier
application number: M017
MQUPIN Lidocaine Gel-PatchLIDOCAINE GEL-PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.49703717-69a6-e480-e063-6394a90ac69c2026-01-28WarningsExact identifier
application number: M017
MQXUNMI LIDOCAINE Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.49706db7-bacd-190f-e063-6394a90a3a8e2026-01-28WarningsExact identifier
application number: M017
Joint and Muscle Relief Topical AnalgesicMENTHOLSmart Cookie Solutions1ecf56b1-ffcb-486f-9fdd-d4dc92aefc1d2026-01-28WarningsExact identifier
application number: M017
VonaFlex Effective Pain Relief Topical AnalgesicLIDOCAINE HYDROCHLORIDEOPTIMAL LABORATORIES, LLC0901244a-7d41-413a-b424-92a807532f282026-01-28WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel PatchLIDOCAINE PAIN RELIEFDynarex960e4240-cd09-2560-e053-2a95a90a7bcf2026-01-28WarningsExact identifier
application number: M017
ALOE ICE SUNBURN RELIEFLIDOCAINE HYDROCHLORIDEAloe Care International, LLC56866fa8-052e-497c-a954-978d7d6289492026-01-28WarningsExact identifier
application number: M017
Walgreens Original Strength Anti ItchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEWalgreen Companya6a49dbb-74c7-47ca-88f2-3bb3d9acf9142026-01-28WarningsExact identifier
application number: M017
Flobow QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD495b10ce-3d2d-1aa4-e063-6294a90a4f352026-01-27WarningsExact identifier
application number: M017
PAINREUSEABLE PAINShenzhen Mengyue Technology Co., Ltd.44e058fc-e1c0-742b-e063-6294a90ad2252026-01-27WarningsExact identifier
application number: M017
HealthWise Pain Relieving Cream LavenderMENTHOLVeridian Healthcare495eb6e9-69da-f7b6-e063-6294a90accee2026-01-27WarningsExact identifier
application number: M017
HealthWise Pain Relieving CreamMENTHOLVeridian Healthcare49548ab2-267e-1e2a-e063-6394a90ab3912026-01-27WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCLWal-Mart Stores, Inc.03feaaef-7401-d464-e063-6294a90a2b2d2026-01-27WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONESTRATEGIC SOURCING SERVICES LLC4a113699-1eb7-49b8-8cdf-2ad57db89b812026-01-27WarningsExact identifier
application number: M017
Healthy Back Institute Rub On ReliefANALGESICFullstack Fulfillment284c29a3-5722-ce70-e063-6394a90a7fa02026-01-26WarningsExact identifier
application number: M017
Velocx for Joint and Muscle Pain Roll-On ApplicatorMENTHOL, METHYL SALICYLATEJMAD Consulting LLC, dba JMAD Labsdbf3eaa3-d85e-46b1-b4a5-a87ba4dc5d212026-01-26WarningsExact identifier
application number: M017
CAPSAICIN HEAT PATCHES BACK AND LARGE AREASCAPSAICINMeijer Distribution Inc9b91658f-c15f-4222-bbd9-881b29de3b6e2026-01-26WarningsExact identifier
application number: M017
TheraCare Muscle and Joint Gel Vanishing ScentMENTHOL 2.5%Veridian Healthcare494d2a85-45a8-12a2-e063-6294a90a391b2026-01-26WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINETrifecta Pharmaceuticals USA, LLC.493c09d0-16d7-7413-e063-6394a90aa0522026-01-26WarningsExact 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