FDA.reportPublic FDA data

Eagle

Product NDC
60954-002
11-digit product format
609540002
Labeler code
60954
Product ID
60954-002_23dc3449-3f69-289c-e063-6394a90ab1f1
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol Methyl Salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Eagle Indo Pharma, PT
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-04
Substance
MENTHOL; METHYL SALICYLATE
Active strength
14.5; 30 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 name suffix
Medicated
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal 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
da338796-de9c-be51-e053-2a95a90a2509Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-002-03EagleMedicated3 mL in 1 BOTTLE, GLASSOIL33
60954-002-03EagleMedicated1 in 1 BOXOIL13
60954-002-24EagleMedicated1 in 1 BOXOIL13
60954-002-24EagleMedicated24 mL in 1 BOTTLE, GLASSOIL243
60954-002-36EagleMedicated1 in 1 BOXOIL13
60954-002-36EagleMedicated36 mL in 1 BOTTLE, GLASSOIL363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-002EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [EAGLE INDO PHARMA, PT]3Current NDC, Legacy NDC, 6 package rows20241009_da338796-de9c-be51-e053-2a95a90a2509.zip

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 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF PATCHESLIDOCAINEWALMART STORES INCb82cfe42-f521-4784-8c60-98481524c5ec2026-01-29WarningsExact identifier
application number: M017
Equate Pain Relief Patch Camphor/Menthol/SalicylateCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Incb869848c-21e2-5ca2-e053-2995a90a86f22026-01-29WarningsExact identifier
application number: M017
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSNda338796-de9c-be51-e053-2a95a90a25093
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSNda338796-de9c-be51-e053-2a95a90a25093
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBDda338796-de9c-be51-e053-2a95a90a25093
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCDda338796-de9c-be51-e053-2a95a90a25093
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSYda338796-de9c-be51-e053-2a95a90a25093
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSYda338796-de9c-be51-e053-2a95a90a25093
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSYda338796-de9c-be51-e053-2a95a90a25093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60954-002-03609540002031 BOTTLE, GLASS in 1 BOX (60954-002-03) / 3 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent
60954-002-24609540002241 BOTTLE, GLASS in 1 BOX (60954-002-24) / 24 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent
60954-002-36609540002361 BOTTLE, GLASS in 1 BOX (60954-002-36) / 36 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent