FDA.reportPublic FDA data

Eagle Medicated Oil

Product NDC
43405-102
11-digit product format
434050102
Labeler code
43405
Product ID
43405-102_238ad881-d836-8b48-e063-6394a90a1f3f
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
2021-06-30
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
c62a4313-2c07-5f58-e053-2995a90a083aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-102-03Eagle Medicated OilRefreshing1 in 1 BOXOIL16
43405-102-03Eagle Medicated OilRefreshing3 mL in 1 BOTTLE, GLASSOIL36
43405-102-08Eagle Medicated OilRefreshing8 mL in 1 BOTTLE, GLASSOIL86
43405-102-08Eagle Medicated OilRefreshing1 in 1 BOXOIL16
43405-102-12Eagle Medicated OilRefreshing12 mL in 1 BOTTLE, GLASSOIL126
43405-102-12Eagle Medicated OilRefreshing1 in 1 BOXOIL16
43405-102-24Eagle Medicated OilRefreshing24 mL in 1 BOTTLE, GLASSOIL246
43405-102-24Eagle Medicated OilRefreshing1 in 1 BOXOIL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-102EAGLE MEDICATED OIL REFRESHING (MENTHOL, METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]6Current NDC, Legacy NDC, 8 package rows20241004_c62a4313-2c07-5f58-e053-2995a90a083a.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 139 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XRay Pain ReliefMENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATEGenomma Lab USA5244ddee-fd9e-4df3-8fb3-b16aa321a3162023-12-27WarningsExact identifier
application number: M017
Camphor SpiritCAMPHOR 10%Pharma Nobis, LLCe42fbe63-b01c-4f85-e053-2a95a90a51432023-12-26WarningsExact identifier
application number: M017
Equate CalasprayPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Walmart Inc027ed5ab-05ec-569f-e063-6394a90abbc32023-12-26WarningsExact identifier
application number: M017
EXTERNAL ANALGESICCAMPHOR, CAPSICUM, MENTHOLHmong 213b6155a5-51aa-2780-e054-00144ff8d46c2023-12-26WarningsExact identifier
application number: M017
LEADER Camphor SpiritCAMPHOR (NATURAL)Cardinal Health, 110 dba Leader7d3b0b28-5190-0622-e053-2991aa0af5612023-12-22WarningsExact identifier
application number: M017
Antiseptic Instant Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharma Nobis, LLCe42f484d-a642-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Itch Relief GelITCH RELIEF GELPharma Nobis, LLCe42f484d-a641-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Witch HazelWITCH HAZELPharma Nobis, LLCe42f484d-a644-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Dermoplast Pain relievingBENZOCAINE, MENTHOLAdvantice Healthdad00c95-4e11-3eec-e053-2a95a90a7a182023-12-21WarningsExact identifier
application number: M017
equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesicLIDOCAINE HYDROCHLORIDEWal-Mart Stores, Inc.bf954949-a7b7-44ba-8565-f1d5c0a6c0d12023-12-21WarningsExact identifier
application number: M017
Bactine Max BandageLIDOCAINEWellSpring Pharmaceutical Corporation465dc46e-6435-4569-9516-f648d0fe0f092023-12-21WarningsExact identifier
application number: M017
Valtrum IMMEDIATE ACTION TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELABORATORIOS QUANTIUM LLCc4efa317-8dd1-49e1-b7ca-9df2147edd3e2023-12-21WarningsExact identifier
application number: M017
DDM Camphor SpiritCAMPHOR 10%Discount Drug Mart5d56cbe6-4e48-79eb-e053-2a91aa0a74d32023-12-20WarningsExact identifier
application number: M017
Quality Choice Camphor SpiritCAMPHOR 10%Chain Drug Market Association8d352a67-2024-43d0-b525-038d398949e62023-12-20WarningsExact identifier
application number: M017
Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Chain Drug Market Association2cd60df3-bfde-4747-ba4f-7121612f2e632023-12-20WarningsExact identifier
application number: M017
Poison Ivy WashPRAMOXINE HCLChain Drug Market Association873a546b-90ae-50cb-e053-2a91aa0adbfb2023-12-20WarningsExact identifier
application number: M017
Premier Value Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharmacy Value Alliance LLC9d63f8ed-fc50-0d84-e053-2a95a90a6e922023-12-20WarningsExact identifier
application number: M017
Ear DropsCARBAMIDE PEROXIDE 6.5%CVS Pharmacy8a872991-01af-5fd0-e053-2995a90ac7f42023-12-20WarningsExact identifier
application number: M017
CVS Cold and Hot Roll-OnCOOL AND HEAT PAIN RELIEFCVS Pharmacyb8cc578a-be6d-90c0-e053-2995a90a77422023-12-20WarningsExact identifier
application number: M017
Sunmark Camphor SpiritCAMPHOR 10%Strategic Sourcing Services LLC667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa2023-12-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560737menthol 14 % / methyl salicylate 15 % Topical OilPSNc62a4313-2c07-5f58-e053-2995a90a083a6
2560737menthol 140 MG/ML / methyl salicylate 150 MG/ML Topical OilSCDc62a4313-2c07-5f58-e053-2995a90a083a6
2560737menthol 14 % / methyl salicylate 15 % Topical OilSYc62a4313-2c07-5f58-e053-2995a90a083a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43405-102-03434050102031 BOTTLE, GLASS in 1 BOX (43405-102-03) / 3 mL in 1 BOTTLE, GLASS2022-06-200000-00-00NoNoCurrent
43405-102-08434050102081 BOTTLE, GLASS in 1 BOX (43405-102-08) / 8 mL in 1 BOTTLE, GLASS2022-06-060000-00-00NoNoCurrent
43405-102-12434050102121 BOTTLE, GLASS in 1 BOX (43405-102-12) / 12 mL in 1 BOTTLE, GLASS2022-06-200000-00-00NoNoCurrent
43405-102-24434050102241 BOTTLE, GLASS in 1 BOX (43405-102-24) / 24 mL in 1 BOTTLE, GLASS2021-06-300000-00-00NoNoCurrent