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 58 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35221a-2fcb-2735-e063-6294a90a88ca2025-12-04WarningsExact identifier
application number: M017
Pain RelievingTROLAMINE SALICYLATECARDINAL HEALTH 110, LLC. DBA LEADERb813262e-57c6-4d2c-8cc0-7a17f6f593432025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Extra Strength BodyMENTHOLGold Bond Co LLC7b75b7de-9c0b-4edf-b923-320f7d2bb1e62025-12-04WarningsExact identifier
application number: M017
Lidocaine PatchLIDOCAINEShenzhen Finona Information Technology Co., Ltd38767081-7011-6602-e063-6394a90a27842025-12-03WarningsExact identifier
application number: M017
4% Lidocaine Maximum Strength Pain ReliefLIDOCAINEShenzhen Finona Information Technology Co., Ltd3e5a5165-a773-0501-e063-6294a90ae2f42025-12-03WarningsExact identifier
application number: M017
Leader LidocaineLIDOCAINE HCLCARDINAL HEALTHcece6765-0e2f-5ce9-e053-2995a90a37582025-12-03WarningsExact identifier
application number: M017
Westlake LidocaineLIDOCAINE HCLWestlake Pharma LLC0c586a14-1a2a-9f42-e063-6294a90a16c12025-12-03WarningsExact identifier
application number: M017
CVS Lidocaine Maximum StrengthLIDOCAINE HCLCVS Pharmacy87490c0f-a4d9-740e-e053-2a95a90a47242025-12-03WarningsExact identifier
application number: M017
CVS Maximum Strength BurnLIDOCAINE HYDROCHLORIDE 4%CVS Pharmacy4510f379-c5a4-92c3-e063-6294a90a0a322025-12-03WarningsExact identifier
application number: M017
LidoPatch Pain ReliefLIDOCAINE, MENTHOLJAR Laboratories07289aa1-43ed-df31-e063-6394a90a764a2025-12-03WarningsExact identifier
application number: M017
Equate Pain Relief Cream4% LIDOCAINE HCLWalmart, Inc7d8e8a9a-5474-4c7b-e053-2991aa0a29f52025-12-03WarningsExact identifier
application number: M017
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation14f23c28-c713-4868-9f46-66363bf94b2c2025-12-03WarningsExact identifier
application number: M017
ElixirCortiReliefHYDROCORTISONEELIXIR HEALTHCARE USA, LLC.a6ca66f3-9759-4c98-a758-45700bc083522025-12-02WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE 4%Trifecta Pharmaceuticals USA, LLC.12a27ce7-c547-7134-e063-6394a90a94bd2025-12-02WarningsExact identifier
application number: M017
5Kind DMSOMENTHOL, METHYL SALICYLATE5KIND TRADING LTD6a6c7241-f544-4784-9581-f5b172fdbec72025-12-02WarningsExact identifier
application number: M017
PEDIADERMICS ECZEMA 2HYDROCORTISONERENU LABORATORIES, LLCda840bf6-ed65-bafc-e053-2a95a90a92d52025-12-02WarningsExact identifier
application number: M017
Thera Plus Maximum Strength HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc7d4e21d1-2914-4690-9084-a52abeab09582025-12-02WarningsExact identifier
application number: M017
Rugby Capsaicin CreamCAPSAICINRugby Laboratories9eca34f1-e91a-3ac1-e053-2a95a90a9bd92025-12-02WarningsExact identifier
application number: M017
Leader Capsaicin Pain Relief CreamCAPSAICINCardinal Health 110 dba LEADERa5620709-0fed-4979-e053-2a95a90ac6542025-12-02WarningsExact identifier
application number: M017
Hydrocortisone Acetate Antipruritic (Anti-Itch)HYDROCORTISONE ACETATESun Pharmaceutical Industries, Inc.9f0b09e7-6cfd-4fd6-8631-67799edf4e082025-12-02WarningsExact 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