FDA.reportPublic FDA data

Eagle

Product NDC
43405-006
11-digit product format
434050006
Labeler code
43405
Product ID
43405-006_238a76dd-0b55-474d-e063-6394a90a65a0
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
2022-03-04
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
d9a93daa-4e24-6690-e053-2a95a90a147cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-006-03EagleMedicated1 in 1 BOXOIL13
43405-006-03EagleMedicated3 mL in 1 BOTTLE, GLASSOIL33
43405-006-24EagleMedicated24 mL in 1 BOTTLE, GLASSOIL243
43405-006-24EagleMedicated1 in 1 BOXOIL13
43405-006-36EagleMedicated36 mL in 1 BOTTLE, GLASSOIL363
43405-006-36EagleMedicated1 in 1 BOXOIL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-006EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]3Current NDC, Legacy NDC, 6 package rows20241004_d9a93daa-4e24-6690-e053-2a95a90a147c.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 106 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Itch ReliefLIDOCAINE HCITrifecta Pharmaceutical USA LLCf40b19a8-795c-f514-e053-2a95a90a6d152024-12-20WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.44d3638d-f29b-0e01-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Rhuli GelCAMPHOR, MENTHOLTrifecta Pharmaceuticals USA, LLC.4fbb3c23-ed47-336e-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONERugby Laboratories132982ea-cce6-687c-e063-6294a90a46322024-12-20WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLC9bb98452-a605-5c20-e053-2995a90a1ea72024-12-20WarningsExact identifier
application number: M017
DCH Cooling Pain ReliefMENTHOL 10.5%Derma Care Research Labs, LLC00dcdae0-c744-8402-e063-6294a90a12f82024-12-20WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLCab95e606-69f0-1d58-e053-2a95a90a073b2024-12-20WarningsExact identifier
application number: M017
Itch Relief CreamZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%Pharmacy Value Alliance LLC37fe6d82-adee-4f58-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Warrior First Aid Anti ItchDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Derma Care Research Labs, LLCec6e9a5b-c61d-a385-e053-2995a90ac9362024-12-20WarningsExact identifier
application number: M017
DCH Burn ReliefLIDOCAINE HCLDerma Care Research Labs, LLCff227154-cf3b-9796-e053-6294a90a55352024-12-20WarningsExact identifier
application number: M017
Outback Pain ReliefCAMPHOR 6%, MENTHOL 16%Derma Care Research Labs, LLCc238c930-2012-2d48-e053-2a95a90a8a4a2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefLIDOCAINE HCL 4%Meijerf31b11ed-2ff9-5cfc-e053-2a95a90af2ca2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefMENTHOL 10.5%Meijerbed81975-bd63-cf5b-e053-2995a90ac5fa2024-12-20WarningsExact identifier
application number: M017
Mirakel Pain and Itch ReliefBENZOCAINE 20%, RESORCINOL 3%Sanvio, Inc.ed34d728-0275-e209-e053-2995a90a93ff2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefLIDOCAINE 4%Meijerbed67c31-c479-6f9b-e053-2a95a90a55162024-12-20WarningsExact identifier
application number: M017
Blue-Emu Ultra with Hemp SeedTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa92024-12-20WarningsExact identifier
application number: M017
Epsom SaltsMAGNESIUM SULFATEInternational Wholesale Inc.e4d9bc32-ac85-349f-e053-2995a90a032f2024-12-19WarningsExact identifier
application number: M017
Epsom SaltsMAGNESIUM SULFATEInternational Wholesale Inc.e5f3edc2-1b79-533a-e053-2a95a90ae9b62024-12-19WarningsExact identifier
application number: M017
LeaderLIDOCAINE HCLCardinal Healthcea6bd2d-a265-1209-e053-2995a90ab0a52024-12-19WarningsExact identifier
application number: M017
Rugby Anti-ItchCAMPHOR, MENTHOLRUGBY LABORATORIES99d8ad9e-46ec-15fc-e053-2995a90a0d172024-12-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSNd9a93daa-4e24-6690-e053-2a95a90a147c3
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSNd9a93daa-4e24-6690-e053-2a95a90a147c3
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBDd9a93daa-4e24-6690-e053-2a95a90a147c3
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCDd9a93daa-4e24-6690-e053-2a95a90a147c3
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSYd9a93daa-4e24-6690-e053-2a95a90a147c3
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSYd9a93daa-4e24-6690-e053-2a95a90a147c3
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSYd9a93daa-4e24-6690-e053-2a95a90a147c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43405-006-03434050006031 BOTTLE, GLASS in 1 BOX (43405-006-03) / 3 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent
43405-006-24434050006241 BOTTLE, GLASS in 1 BOX (43405-006-24) / 24 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent
43405-006-36434050006361 BOTTLE, GLASS in 1 BOX (43405-006-36) / 36 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent