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 19 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC3f2b1f48-2d78-4985-a046-9f72de5e1a9b2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC10a8face-47da-ebbe-e063-6294a90a42fe2026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot CreamMENTHOLReckitt Benckiser LLC32450cbf-4ed4-402b-a30e-e08a17bba3fb2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLCa227213b-e89f-7144-e053-2a95a90a7e742026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC00bb462a-27d0-6f74-e063-6394a90a90ec2026-05-13WarningsExact identifier
application number: M017
BioFreeze Dry StickMENTHOLReckitt Benckiser LLC26d62cd2-9209-8cca-e063-6394a90a20282026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot Pain Relief SetMENTHOLReckitt Benckiser LLC4a885eef-0364-4655-bccc-7158c76cc5b22026-05-13WarningsExact identifier
application number: M017
Biofreeze Colorless Roll-OnMENTHOLReckitt Benckiser LLCa8d59d45-0e85-43d1-affd-bbe922c4acb12026-05-13WarningsExact identifier
application number: M017
Biofreeze ColorlessMENTHOLReckitt Benckiser LLC939dbbc3-71ec-4990-840e-7c9b8d4305622026-05-13WarningsExact identifier
application number: M017
Biofreeze Flexible Relief StripMENTHOLReckitt Benckiser LLC6ec26bae-e395-49aa-969e-8c653d6f0b272026-05-13WarningsExact identifier
application number: M017
Biofreeze Day and OvernightMENTHOLReckitt Benckiser LLCfb5c8f89-a720-ad32-e053-6294a90a2abe2026-05-13WarningsExact identifier
application number: M017
Biofreeze FoamMENTHOLReckitt Benckiser LLC890191e8-99ad-489c-8f21-2592f3d319362026-05-13WarningsExact identifier
application number: M017
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP51b7753b-8619-6ea9-e063-6294a90a4ea42026-05-13WarningsExact identifier
application number: M017
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
application number: M017
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
application number: M017
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
application number: M017
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
application number: M017
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact 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