FDA.reportPublic FDA data

Eagle Brand

Product NDC
43405-015
11-digit product format
434050015
Labeler code
43405
Product ID
43405-015_1b9fdac0-9fb1-e669-e063-6394a90aece9
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
2024-06-24
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
Brand name suffix
Medicated Oil
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
1b9fdac0-9fb0-e669-e063-6394a90aece9Available 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
43405-015-24Eagle BrandMedicated Oil24 mL in 1 BOTTLE, GLASSOIL241
43405-015-24Eagle BrandMedicated Oil1 in 1 BOXOIL11
43405-015-36Eagle BrandMedicated Oil36 mL in 1 BOTTLE, GLASSOIL361
43405-015-36Eagle BrandMedicated Oil1 in 1 BOXOIL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-015EAGLE BRAND MEDICATED OIL (MENTHOL, METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]1Current NDC, 4 package rows20240626_1b9fdac0-9fb0-e669-e063-6394a90aece9.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 111 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEMeijer Distribution Inc75c6fcd5-185c-4203-b604-19ce801c865f2024-12-18WarningsExact identifier
application number: M017
MEIJER PAIN RELIEF PATCHESLIDOCAINEMeijer Distribution Incaa5da66d-3ba9-4120-be35-44bec475761a2024-12-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%CVS Pharmacy8a9757e3-0bfc-a1e2-e053-2a95a90a6da32024-12-18WarningsExact identifier
application number: M017
Dollar General Cold-Hot Medicated PatchesMENTHOLDOLGENCORP, LLCc6e0388b-af9e-4e51-8f94-6788185c31a02024-12-18WarningsExact identifier
application number: M017
THERA CARE PAIN THERAPYLIDOCAINEVeridian Healthcaree023bb5a-a4bc-4681-a1f4-48ca0d2cb1022024-12-18WarningsExact identifier
application number: M017
TheraCare Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEVeridian Healthcaref6f3c9c0-d6e3-75a3-e053-6294a90a19652024-12-18WarningsExact identifier
application number: M017
Good Sense Hot and Cold Medicated PatchMENTHOLGOOD SENSE1b16c3e5-a29f-4043-94e6-0a0e0ea3d93e2024-12-18WarningsExact identifier
application number: M017
Hunter Beach 4%LIDOCAINEHUNTERS BEACH LIFEf2ef9c12-6e42-486b-b6f2-0ad534e942942024-12-18WarningsExact identifier
application number: M017
Hunter Beach 4%LIDOCAINEHUNTERS BEACH LIFE05a9605b-0d01-4333-8e54-7202e7c31c492024-12-18WarningsExact identifier
application number: M017
Ultra Strength Muscle RubCAMPHOR, MENTHOL, METHYL SALICYLATEThe Mentholatum Company32b64985-0e2f-49ee-9840-946d7279fee72024-12-17WarningsExact identifier
application number: M017
WellPatch Warming Pain ReliefCAPSAICINThe Mentholatum Companyec583129-55fc-4ab1-94e5-9c900b5d95ef2024-12-17WarningsExact identifier
application number: M017
CVS Health Cold and Hot Pain Relieving Extra StrengthMENTHOL, METHYL SALICYLATECVS Pharmacy1ca1a631-cb2c-46cd-bd41-05469b08d2082024-12-17WarningsExact identifier
application number: M017
Mentholatum Pain RelievingMENTHOL, METHYL SALICYLATEThe Mentholatum Company0056b952-9870-485a-9f35-f985472875a92024-12-17WarningsExact identifier
application number: M017
Mentholatum Lidocaine HeatLIDOCAINE HCLThe Mentholatum Companycc2ef25a-b569-4d48-a666-899f710b4b342024-12-17WarningsExact identifier
application number: M017
Rite Aid Muscle Rub Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATERite Aid Corporation039fff40-b5ba-42cb-932c-8a70ca92759d2024-12-17WarningsExact identifier
application number: M017
Signature Care Cold and Hot MedicatedMENTHOLSafeway88f59f95-0a7c-458c-949c-0dff16ad94e42024-12-17WarningsExact identifier
application number: M017
Equate Cool and HeatMENTHOL, METHYL SALICYLATEWal-Mart Stores Incc5ab2426-eeca-4ba4-9f00-7790d21764712024-12-17WarningsExact identifier
application number: M017
Equate Capsaicin Pain RelievingCAPSAICINWal-Mart Stores Inc745b2cf5-2599-4383-818b-19fed248a11f2024-12-17WarningsExact identifier
application number: M017
CVS Health Muscle Rub Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a2024-12-17WarningsExact identifier
application number: M017
DG Health Maximum Strength Pain Relieving CleansingBENZALKONIUM CL, LIDOCAINE HCLDollar General Corporation64f69315-77a3-49dc-940d-efd7a29c66452024-12-17WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSN1b9fdac0-9fb0-e669-e063-6394a90aece91
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSN1b9fdac0-9fb0-e669-e063-6394a90aece91
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBD1b9fdac0-9fb0-e669-e063-6394a90aece91
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCD1b9fdac0-9fb0-e669-e063-6394a90aece91
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSY1b9fdac0-9fb0-e669-e063-6394a90aece91
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSY1b9fdac0-9fb0-e669-e063-6394a90aece91
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSY1b9fdac0-9fb0-e669-e063-6394a90aece91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43405-015-24434050015241 BOTTLE, GLASS in 1 BOX (43405-015-24) / 24 mL in 1 BOTTLE, GLASS2024-06-24NoNoCurrent
43405-015-36434050015361 BOTTLE, GLASS in 1 BOX (43405-015-36) / 36 mL in 1 BOTTLE, GLASS2024-06-24NoNoCurrent