FDA.reportPublic FDA data

Eagle

Product NDC
43405-008
11-digit product format
434050008
Labeler code
43405
Product ID
43405-008_304b364d-2847-f1a8-e063-6294a90aa948
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol Methyl Salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Borden Company (Private) Limited
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-05-14
Substance
METHYL SALICYLATE; MENTHOL
Active strength
30; 14.5 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
METHYL SALICYLATE30 g/100mL
MENTHOL14.5 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 · 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
1ee49cad-84d4-42cf-aa83-c0da6f1b1b84Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-008-01EagleMedicated1 in 1 BOXOIL18
43405-008-02EagleMedicated1 in 1 BOXOIL18
43405-008-03EagleMedicated3 mL in 1 BOTTLE, GLASSOIL38
43405-008-08EagleMedicated1 in 1 BOXOIL18
43405-008-08EagleMedicated8 mL in 1 BOTTLE, GLASSOIL88
43405-008-13EagleMedicated1 in 1 BOXOIL18
43405-008-24EagleMedicated24 mL in 1 BOTTLE, GLASSOIL248
43405-008-36EagleMedicated36 mL in 1 BOTTLE, GLASSOIL368

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AEAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]3
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YEAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]3
MENTHOLACTIVE MOIETYL7T10EIP3AEAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZEAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MEAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]3
CHLOROPHYLLINACTIVE INGREDIENT00WNZ48OR9EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPEAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]3
ROSE OILINACTIVE INGREDIENTWUB68Y35M7EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-008EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]8Current NDC, Legacy NDC, 8 package rows20250316_1ee49cad-84d4-42cf-aa83-c0da6f1b1b84.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
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSN1ee49cad-84d4-42cf-aa83-c0da6f1b1b848
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSN1ee49cad-84d4-42cf-aa83-c0da6f1b1b848
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBD1ee49cad-84d4-42cf-aa83-c0da6f1b1b848
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCD1ee49cad-84d4-42cf-aa83-c0da6f1b1b848
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSY1ee49cad-84d4-42cf-aa83-c0da6f1b1b848
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSY1ee49cad-84d4-42cf-aa83-c0da6f1b1b848
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSY1ee49cad-84d4-42cf-aa83-c0da6f1b1b848

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43405-008-01434050008011 BOTTLE, GLASS in 1 BOX (43405-008-01) / 24 mL in 1 BOTTLE, GLASS (43405-008-24) 2012-05-140000-00-00NoNoCurrent
43405-008-02434050008021 BOTTLE, GLASS in 1 BOX (43405-008-02) / 36 mL in 1 BOTTLE, GLASS (43405-008-36) 2012-05-140000-00-00NoNoCurrent
43405-008-03434050008033 mL in 1 BOTTLE, GLASS3 mlHistorical
43405-008-08434050008081 BOTTLE, GLASS in 1 BOX (43405-008-08) / 8 mL in 1 BOTTLE, GLASS2022-06-270000-00-00NoNoCurrent
43405-008-13434050008131 BOTTLE, GLASS in 1 BOX (43405-008-13) / 3 mL in 1 BOTTLE, GLASS (43405-008-03) 2012-05-140000-00-00NoNoCurrent
43405-008-244340500082424 mL in 1 BOTTLE, GLASS24 mlHistorical
43405-008-364340500083636 mL in 1 BOTTLE, GLASS36 mlHistorical