FDA.reportPublic FDA data

Eagle Medicated Oil

Product NDC
60954-005
11-digit product format
609540005
Labeler code
60954
Product ID
60954-005_23da2b09-f7f1-57d7-e063-6394a90a8713
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
2022-06-20
Substance
METHYL SALICYLATE; MENTHOL
Active strength
15; 14 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 Medicated Oil
Brand name suffix
Refreshing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE15 g/100mL
MENTHOL14 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2560737Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2729023-d689-7ae2-e053-2a95a90a78dcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-005-03Eagle Medicated OilRefreshing1 in 1 BOXOIL12
60954-005-03Eagle Medicated OilRefreshing3 mL in 1 BOTTLE, GLASSOIL32
60954-005-08Eagle Medicated OilRefreshing8 mL in 1 BOTTLE, GLASSOIL82
60954-005-08Eagle Medicated OilRefreshing1 in 1 BOXOIL12
60954-005-12Eagle Medicated OilRefreshing1 in 1 BOXOIL12
60954-005-12Eagle Medicated OilRefreshing12 mL in 1 BOTTLE, GLASSOIL122
60954-005-24Eagle Medicated OilRefreshing1 in 1 BOXOIL12
60954-005-24Eagle Medicated OilRefreshing24 mL in 1 BOTTLE, GLASSOIL242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-005EAGLE MEDICATED OIL REFRESHING (MENTHOL, METHYL SALICYLATE) OIL [EAGLE INDO PHARMA, PT]2Current NDC, Legacy NDC, 8 package rows20241008_e2729023-d689-7ae2-e053-2a95a90a78dc.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 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbc66bc1b-c0d5-2481-e053-2a95a90a75de2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafd199a-e198-d5d1-e053-2995a90ad1cb2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafdf06b-25f5-e29e-e053-2a95a90a5e1b2025-12-04WarningsExact identifier
application number: M017
MilagrosoMETHYL SALICYLATEPharmadel LLCfdcc8f44-afa0-3af0-e053-6394a90aa46d2025-12-04WarningsExact identifier
application number: M017
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560737menthol 14 % / methyl salicylate 15 % Topical OilPSNe2729023-d689-7ae2-e053-2a95a90a78dc2
2560737menthol 140 MG/ML / methyl salicylate 150 MG/ML Topical OilSCDe2729023-d689-7ae2-e053-2a95a90a78dc2
2560737menthol 14 % / methyl salicylate 15 % Topical OilSYe2729023-d689-7ae2-e053-2a95a90a78dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60954-005-03609540005031 BOTTLE, GLASS in 1 BOX (60954-005-03) / 3 mL in 1 BOTTLE, GLASS2022-06-200000-00-00NoNoCurrent
60954-005-08609540005081 BOTTLE, GLASS in 1 BOX (60954-005-08) / 8 mL in 1 BOTTLE, GLASS2022-06-200000-00-00NoNoCurrent
60954-005-12609540005121 BOTTLE, GLASS in 1 BOX (60954-005-12) / 12 mL in 1 BOTTLE, GLASS2022-06-200000-00-00NoNoCurrent
60954-005-24609540005241 BOTTLE, GLASS in 1 BOX (60954-005-24) / 24 mL in 1 BOTTLE, GLASS2022-06-200000-00-00NoNoCurrent