FDA.reportPublic FDA data

Eagle

Product NDC
43405-005
11-digit product format
434050005
Labeler code
43405
Product ID
43405-005_3268eba3-2aff-5403-e063-6394a90a6a0e
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
da3358ae-8679-6045-e053-2a95a90a50e3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-005-08EagleMedicated1 in 1 BOXOIL13
43405-005-08EagleMedicated8 mL in 1 BOTTLE, WITH APPLICATOROIL83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-005EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]3Current NDC, Legacy NDC, 2 package rows20250411_da3358ae-8679-6045-e053-2a95a90a50e3.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 43 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLT 2LIDOCAINE HCLCENTURA PHARMACEUTICALS INC41dc85ec-d79b-0a32-e054-00144ff8d46c2026-01-12WarningsExact identifier
application number: M017
Mineral Ice Pain RelievingMENTHOLCrown Laboratories7b30076a-0af6-2f74-e053-2a91aa0ae08d2026-01-12WarningsExact identifier
application number: M017
SarnaPRAMOXINE HYDROCHLORIDECrown Laboratories19b0ce1b-e147-01a1-e063-6394a90af8082026-01-12WarningsExact identifier
application number: M017
SarnaPRAMOXINE HYDROCHLORIDE, MENTHOLCrown Laboratories, Inc19c41e75-a654-90cf-e063-6394a90a7e972026-01-12WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEHY-VEE, INC48350b54-8d9a-48c4-e063-6394a90ac0402026-01-12WarningsExact identifier
application number: M017
LidoPlus Pain ReliefLIDOCAINE HYDROCHLORIDECentura Pharmaceuticals, Inc07bacc6c-60a6-4297-8663-904a22bdc0402026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf1efb51c-5217-4cb2-e053-2a95a90a7f952026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf2277e27-868b-57ef-e053-2a95a90abf282026-01-12WarningsExact identifier
application number: M017
BLT 3TETRACAINECENTURA PHARMACEUTICALS INC401a0d22-1181-02ac-e054-00144ff88e882026-01-12WarningsExact identifier
application number: M017
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.0c901f64-6890-45c0-9ca7-ee9de87903c42026-01-12WarningsExact identifier
application number: M017
Goodsense Oral Pain ReliefBENZOCAINEGeiss, Destin and Dunn, Inc.eb461b70-d10f-4e11-8374-e43713f3504d2026-01-12WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM AND MENTHOLSaje Natural Business Incf516e416-446b-8f21-e053-2a95a90afd882026-01-12WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.3df0e56a-7651-42dc-8ed8-f68836a63c612026-01-12WarningsExact identifier
application number: M017
Trauma LessMENTHOLSaje Natural Business Inc.650cba4c-6aba-48c3-9c41-841f199055482026-01-12WarningsExact identifier
application number: M017
MamisanLIDOCAINE HYDROCHLORIDE, MENTHOLMiramar Cosmetics, Inc DBA Miramar Lab4402e900-c6e9-4f32-8cc4-c84014384a9f2026-01-12WarningsExact identifier
application number: M017
Curist Lidocaine PatchLIDOCAINE 4% PATCHLittle Pharma, Inc.1a8fe44e-7a21-c2ab-e063-6394a90a61002026-01-11WarningsExact identifier
application number: M017
DG Health Pain RelievingLIDOCAINE HCLDOLGENCORP, LLC923aeb4c-049f-4ecc-a77e-9ffa0e236d4e2026-01-11WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare46b84e0b-78a9-4cde-9f90-e165b54191622026-01-09WarningsExact identifier
application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-OnMENTHOLInspec Solutions12ff9b9a-73e5-ce31-e063-6294a90aeaf82026-01-09WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bb0278c9-eaff-d435-e053-2995a90a202a2026-01-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSNda3358ae-8679-6045-e053-2a95a90a50e33
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSNda3358ae-8679-6045-e053-2a95a90a50e33
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBDda3358ae-8679-6045-e053-2a95a90a50e33
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCDda3358ae-8679-6045-e053-2a95a90a50e33
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSYda3358ae-8679-6045-e053-2a95a90a50e33
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSYda3358ae-8679-6045-e053-2a95a90a50e33
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSYda3358ae-8679-6045-e053-2a95a90a50e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43405-005-08434050005081 BOTTLE, WITH APPLICATOR in 1 BOX (43405-005-08) / 8 mL in 1 BOTTLE, WITH APPLICATOR2022-03-040000-00-00NoNoCurrent