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 34 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF4a7f92d3-dd35-44a3-e063-6294a90ae0042026-02-10WarningsExact identifier
application number: M017
NICOVITO HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4a5e24fa-959e-79b4-e063-6294a90a8f682026-02-09WarningsExact identifier
application number: M017
Tiger Balm Active Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.2e7638c6-e1ce-4e2f-bd50-52fbce5a138e2026-02-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.2f272d12-7b34-430e-817e-1005f57ed9e92026-02-09WarningsExact identifier
application number: M017
Welmate Lidocaine Pain Relieving PatchLIDOCAINEYYBA CORP4303fd30-0d35-3671-e063-6394a90a2aee2026-02-09WarningsExact identifier
application number: M017
Pain Relief LidocaineLIDOCAINEKroger Company4098756e-3d9f-317a-e063-6394a90af04c2026-02-09WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey4a698246-05a6-d01f-e063-6294a90a34012026-02-09WarningsExact identifier
application number: M017
Hemorrhoid MasterLIDOCAINE, PHENYLEPHRINEEbanel Laboratories, Inc41292d65-dabe-4bc3-872f-34a3912aa3422026-02-09WarningsExact identifier
application number: M017
DERMFREE NEUROPATHYARNICA MONTANA 1X HPUS 7% NEUROPATHYJiangxi Yudexi Pharmaceutical Co., LTD4a5c232d-5d29-2504-e063-6394a90ac9de2026-02-08WarningsExact identifier
application number: M017
ASSIELF NUMBING Topical AnorectalLIDOCAINEShenzhen Yuanbang International Logistics Co., Ltd4a5cb477-57ef-2a1d-e063-6394a90ac9ed2026-02-08WarningsExact identifier
application number: M017
Lidocaine Pain Relieve Gel-PatchPAIN RELIEVE GEL-PATCHHenan Kangdi Medical Devices Co., Ltd1e31b950-e990-e255-e063-6394a90a7d232026-02-07WarningsExact identifier
application number: M017
Herbal Knee PatchHERBAL KNEE PATCHHenan Kangdi Medical Devices Co., Ltd2a009059-b515-8214-e063-6294a90a4ed32026-02-07WarningsExact identifier
application number: M017
Flocean ANTI-ITCHBENZOCAINE 5%ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a493911-a846-5aa0-e063-6294a90a65ac2026-02-07WarningsExact identifier
application number: M017
daily solutions Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMGarcoa, Inc.4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e62026-02-06WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEShenzhen Wankelai E-commerce Co., Ltd.4a22562b-601e-97d7-e063-6394a90a5bca2026-02-06WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESportpharm LLCee64ad1e-78db-4553-a3cf-b539b770fa262026-02-06WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE 4%Sportpharm LLC1dd022b9-88ae-4737-88cc-fdb0ce0a83a32026-02-06WarningsExact identifier
application number: M017
Camphor plus Lidocaine Pain ReliefCAMPHOR, LIDOCAINEVeridian Healthcare4a2b73a8-c10c-85f9-e063-6294a90ac52c2026-02-06WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLRetail Business Services, LLC073c72fe-3171-4a4f-913a-d1b9630a1af32026-02-06Warnings, Adverse reactionsExact identifier
application number: M017
HealthWise Soothing Lidocaine Pain ReliefLIDOCAINE HCI 0.5%Veridian Healthcare4a2ec73e-7332-6f13-e063-6294a90a85062026-02-06WarningsExact 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