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 91 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaD ANTI-ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.8f4a57cb-0a5b-42b0-a325-1f92f3942ad92025-05-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.f7aecfb4-c194-4554-8d05-4e46005e654b2025-05-27WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATENantong Health & Beyond Hygienic Products Inc.b679ed7b-9d88-4eff-9743-567affe0fe2b2025-05-27WarningsExact identifier
application number: M017
RockSauce Warming Massage Roll OnMENTHOL, METHYL SALICYLATENantong Health & Beyond Hygienic Products Inc.28eb8273-5789-4f33-bbbe-3a5ec7bc79292025-05-27WarningsExact identifier
application number: M017
AUVON Pain Relief CreamLIDOCAINESHENZHEN YUWEN E-COMMERCE CO., LTD.358c2632-3b90-1c54-e063-6294a90ad4612025-05-22WarningsExact identifier
application number: M017
WelAhead by Welmate Lidocaine 5% Roll-onLIDOCAINE 5%OTC PHARM LLC0b75e83e-8c7b-6247-e063-6294a90ac4132025-05-21WarningsExact identifier
application number: M017
Bliss RepublicLIDOCAINE NUMBING EXTRA STRENGTH CREAMSargass Group Limited Liability Company35aba13a-95e6-a395-e063-6294a90a5bdc2025-05-21WarningsExact identifier
application number: M017
Xpect Stopain ClinicalMENTHOLCintas Corporatione911478f-7153-4700-b945-92ec54972f452025-05-21WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHPreferred Pharmaceuticals Inc.0976a898-8d79-4b85-b473-c8ad32b4fd002025-05-20WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC359884d6-188a-e503-e063-6294a90acab42025-05-20WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO - THERMOACTIVE LOTION835abc66-680f-be06-e053-2a91aa0a309e2025-05-19WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC35884644-d017-eda3-e063-6394a90a1f6c2025-05-19WarningsExact identifier
application number: M017
QUIT SMOKING Proven PatchesNICOTINEJiashen International Trade Limited35570155-c769-dc4c-e063-6394a90a019d2025-05-17WarningsExact identifier
application number: M017
VBBV Tattoo NumbingLIDOCAINEJiashen International Trade Limited3557859e-f8b3-1049-e063-6394a90ad7372025-05-17WarningsExact identifier
application number: M017
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company35415851-beba-5bb4-e063-6294a90a35c02025-05-16WarningsExact identifier
application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd352798e1-1e09-3d47-e063-6394a90ad4042025-05-15WarningsExact identifier
application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd35285d62-c660-a056-e063-6294a90aabc82025-05-15WarningsExact identifier
application number: M017
SionBiotext HydrocortisoneHYDROCORTISONE ACETATE 1%Sion Biotext Medical Ltd35073eae-26fe-2bb5-e063-6294a90ab56a2025-05-13WarningsExact identifier
application number: M017
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company3508ae14-d9c9-3c85-e063-6294a90a00982025-05-13WarningsExact identifier
application number: M017
SORE NO MORE WARM THERAPYMENTHOL AND CAMPHORSOMBRA COSMETICS INC.cd86b56e-9b4c-4aca-9740-c8793cb120552025-05-12WarningsExact 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