FDA.reportPublic FDA data

Eagle

Product NDC
60954-008
11-digit product format
609540008
Labeler code
60954
Product ID
60954-008_23dc4921-4049-2501-e063-6394a90a4932
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol Methyl Salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Eagle Indo Pharma
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-20
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
e2c5f821-cdd5-190d-e053-2a95a90a9159Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-008-03EagleMedicated1 in 1 BOXOIL12
60954-008-03EagleMedicated3 mL in 1 BOTTLE, GLASSOIL32
60954-008-08EagleMedicated1 in 1 BOXOIL12
60954-008-08EagleMedicated8 mL in 1 BOTTLE, GLASSOIL82
60954-008-24EagleMedicated24 mL in 1 BOTTLE, GLASSOIL242
60954-008-24EagleMedicated1 in 1 BOXOIL12
60954-008-36EagleMedicated36 mL in 1 BOTTLE, GLASSOIL362
60954-008-36EagleMedicated1 in 1 BOXOIL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-008EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [EAGLE INDO PHARMA]2Current NDC, Legacy NDC, 8 package rows20241009_e2c5f821-cdd5-190d-e053-2a95a90a9159.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 49 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF PATCHESLIDOCAINEHarris Teeter5a0501e8-bc06-4e33-8db8-93b21a7151412025-12-29WarningsExact identifier
application number: M017
Hot and Cold Medicated PatchMENTHOLHarris Teeter9debd4ef-c21b-41ae-afd1-58f47c51c99c2025-12-29WarningsExact identifier
application number: M017
Maximum OTC Strength Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)0e9a711c-ddf4-af63-e063-6294a90a0ebe2025-12-29WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEHarris Teeter3f5b4eee-49c4-408c-9af2-e7924c26ac632025-12-29WarningsExact identifier
application number: M017
talc-free medicated bodyMENTHOLDavion, Inc27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b2025-12-29WarningsExact identifier
application number: M017
H-E-B Medicated Corn Starch Foot PowderMENTHOLDavion, Inca6675e00-bc6b-4466-a283-4cece5f919702025-12-29WarningsExact identifier
application number: M017
Maximum Strength Medicated Foot PowderMENTHOLDavion, Inc7b442d99-ac19-4f65-828d-954c5350ef5a2025-12-29WarningsExact identifier
application number: M017
HEB Medicated Cornstarch Body PowderMENTHOLDavion, Incdf1331fb-48df-4f21-8564-0468078fd12d2025-12-29WarningsExact identifier
application number: M017
Honest Med Capsaicin PatchCAPSAICINProper Buys LLC30169d44-b1b2-5c0f-e063-6294a90ae1592025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Lavender Roll-onLIDOCAINE HCLProper Buys LLC2dcd40a9-3fdd-a71e-e063-6294a90a704f2025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Pain Relief PatchLIDOCAINEProper Buys LLC13a5243f-7116-e4da-e063-6394a90aa5432025-12-28WarningsExact identifier
application number: M017
CVS Health Pain-Relieving PatchMENTHOL, METHYL SALICYLATE, CAMPHORCVS Pharmacy, Inc.1f90899c-eeca-2362-e063-6294a90aa0da2025-12-28WarningsExact identifier
application number: M017
CVS Health Cooling PatchMENTHOLCVS Pharmacy, Inc1f90cefe-bcce-5e17-e063-6294a90a57362025-12-28WarningsExact identifier
application number: M017
Point Relief LidoSpot with MentholLIDOCAINE, MENTHOLFabrication Enterprisesf0c69693-bfea-4006-9620-63b222d25d382025-12-28WarningsExact identifier
application number: M017
DISCOUNT DRUG MART PAIN RELIEF PATCHESLIDOCAINEDiscount Drug Mart, Ince36e7d0a-d554-4601-b535-b41ee84a6b242025-12-28WarningsExact identifier
application number: M017
Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEDiscount Drug Mart, Incc01e1a14-bfbc-4c52-8a67-b77acf2d88532025-12-28WarningsExact identifier
application number: M017
TopCare Pain Relief PatchLIDOCAINE, MENTHOLTopco Associates LLCd4c89c4f-d69a-7786-e053-2995a90a71e72025-12-28WarningsExact identifier
application number: M017
Kroger Lidocaine Pain RelievingLIDOCAINE HCLKroger Company12d94ba6-56ac-3816-e063-6394a90a44c62025-12-28WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEAhold U.S.A., Inc,7e7a813e-424d-4a78-9c72-541c3c62606a2025-12-28WarningsExact identifier
application number: M017
Amazon Basics Cold and Hot Medicated PatchMENTHOLAmazon.com Services LLCe3b4db12-c846-b984-e053-2a95a90a8e9a2025-12-28WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSNe2c5f821-cdd5-190d-e053-2a95a90a91592
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSNe2c5f821-cdd5-190d-e053-2a95a90a91592
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBDe2c5f821-cdd5-190d-e053-2a95a90a91592
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCDe2c5f821-cdd5-190d-e053-2a95a90a91592
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSYe2c5f821-cdd5-190d-e053-2a95a90a91592
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSYe2c5f821-cdd5-190d-e053-2a95a90a91592
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSYe2c5f821-cdd5-190d-e053-2a95a90a91592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60954-008-03609540008031 BOTTLE, GLASS in 1 BOX (60954-008-03) / 3 mL in 1 BOTTLE, GLASS2022-06-270000-00-00NoNoCurrent
60954-008-08609540008081 BOTTLE, GLASS in 1 BOX (60954-008-08) / 8 mL in 1 BOTTLE, GLASS2022-06-270000-00-00NoNoCurrent
60954-008-24609540008241 BOTTLE, GLASS in 1 BOX (60954-008-24) / 24 mL in 1 BOTTLE, GLASS2022-06-270000-00-00NoNoCurrent
60954-008-36609540008361 BOTTLE, GLASS in 1 BOX (60954-008-36) / 36 mL in 1 BOTTLE, GLASS2022-06-270000-00-00NoNoCurrent