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 135 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ralli Rapid Pain Relief Roll onMENTHOLTroy Manufacturing, Inc.978d5c2c-fdc4-4d25-83ec-0b9404ec80182024-02-19WarningsExact identifier
application number: M017
11681168 BURN SPRAYDynarex Corporation1183a4f5-f875-dfb0-e063-6394a90af35f2024-02-16WarningsExact identifier
application number: M017
Pain ReliefBENZOCAINESafetec of America, Inc.de84e598-d047-4fae-b2ed-155a3788bc6f2024-02-16WarningsExact identifier
application number: M017
No Mess Hydrocortisone ApplicatorHYDROCORTISONEWalgreen Co.cfefb517-9099-41c4-8a95-74414ca4032c2024-02-16WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpab9bf09d-bc8c-6d17-e053-2995a90a6c362024-02-14WarningsExact identifier
application number: M017
Natures Oil 16% MentholMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.2fbe23b7-23a3-4f0b-bc08-0205256f5d682024-02-14WarningsExact identifier
application number: M017
Rugby Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATERugby Laboratories4c11876c-57ec-4429-a8c4-fb95baa4074a2024-02-13WarningsExact identifier
application number: M017
Itch stopping CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Trifecta Pharmaceuticals USA, LLC.11368823-d4af-a536-e063-6294a90a7a2e2024-02-12WarningsExact identifier
application number: M017
Walgreens Boil Pain ReliefBOIL PAIN RELIEFWalgreens Companyd11bd769-68d0-4057-bc2a-72719f16011e2024-02-12WarningsExact identifier
application number: M017
CapsaicinCAPSAICINRugby Laboratoriesc5915c84-84a2-46f6-9f97-0d9873e9944a2024-02-12WarningsExact identifier
application number: M017
Leader Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADER952e56ea-5cbc-4078-bd01-5d3b6864a5ce2024-02-09WarningsExact identifier
application number: M017
Leader Ultra Strength Muscle Rub Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATECardinal Health, 110 dba LEADER9d99a900-60e0-454c-98e0-2c63eb910cf12024-02-09WarningsExact identifier
application number: M017
Pain RelievingCAMPHOR (NATURAL)J.R. Watkins, LLC.28821ffa-a138-47b5-8857-beadf7a20d432024-02-08WarningsExact identifier
application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic RubCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.fd0ea70a-ef12-48b1-8d9d-cc5f6417f8542024-02-08WarningsExact identifier
application number: M017
Pain Relieving CoolingMENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.3574d48a-b546-4ea7-b470-071bb328de642024-02-08WarningsExact identifier
application number: M017
Advil Targeted ReliefCAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATEHaleon US Holdings LLC16e6be21-7b43-443a-89ec-3bdf0ec0dfc12024-02-08WarningsExact identifier
application number: M017
POINT RELIEF COLD SPOT Pain RelievingMENTHOLFABRICATION ENTERPRISES96f1d592-6cec-412e-a5fd-cf3c4f68644f2024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.1c5eb3b3-79b3-472a-ae36-ec6a7dc729252024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.8eb3e7e2-26e5-430e-89aa-40a0367c637e2024-02-07WarningsExact identifier
application number: M017
Nova Natura Topical AnalgesicCAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATESEYITLER KIMYA SANAYI ANONIM SIRKETIabf00f73-f0b1-439e-85aa-bbce8a1ec9202024-02-06WarningsExact 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