FDA.reportPublic FDA data

Eagle

Product NDC
43405-010
11-digit product format
434050010
Labeler code
43405
Product ID
43405-010_238a94b3-804f-33e0-e063-6394a90ac140
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol Methyl Salicylate
Dosage form
LIQUID
Route
TOPICAL
Labeler
Borden Company (Private) Limited
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-15
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
Extra Strength
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1654726Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e02fbe3-5bc7-430e-b661-3a760ddd8fe0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-010-01EagleExtra Strength1 in 1 BOXLIQUID14
43405-010-85EagleExtra Strength85 mL in 1 BOTTLE, GLASSLIQUID854

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AEAGLE EXTRA STRENGTH (MENTHOL METHYL SALICYLATE) LIQUID [BORDEN COMPANY (PRIVATE) LIMITED ]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YEAGLE EXTRA STRENGTH (MENTHOL METHYL SALICYLATE) LIQUID [BORDEN COMPANY (PRIVATE) LIMITED ]1
MENTHOLACTIVE MOIETYL7T10EIP3AEAGLE EXTRA STRENGTH (MENTHOL METHYL SALICYLATE) LIQUID [BORDEN COMPANY (PRIVATE) LIMITED ]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZEAGLE EXTRA STRENGTH (MENTHOL METHYL SALICYLATE) LIQUID [BORDEN COMPANY (PRIVATE) LIMITED ]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MEAGLE EXTRA STRENGTH (MENTHOL METHYL SALICYLATE) LIQUID [BORDEN COMPANY (PRIVATE) LIMITED ]1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETEAGLE EXTRA STRENGTH (MENTHOL METHYL SALICYLATE) LIQUID [BORDEN COMPANY (PRIVATE) LIMITED ]1
THYMOLINACTIVE INGREDIENT3J50XA376EEAGLE EXTRA STRENGTH (MENTHOL METHYL SALICYLATE) LIQUID [BORDEN COMPANY (PRIVATE) LIMITED ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-010EAGLE EXTRA STRENGTH (MENTHOL METHYL SALICYLATE) LIQUID [BORDEN COMPANY (PRIVATE) LIMITED]4Current NDC, Legacy NDC, 2 package rows20241004_5e02fbe3-5bc7-430e-b661-3a760ddd8fe0.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 17 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
application number: M017
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
application number: M017
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
application number: M017
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact identifier
application number: M017
DO ME DELAYLIDOCAINE HCLProdigy Media Inc5255ee85-6f29-0776-e063-6394a90a525b2026-05-21WarningsExact identifier
application number: M017
Australian Dream Back PainHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.5256a63e-e6da-84c1-e063-6294a90a8dff2026-05-21WarningsExact identifier
application number: M017
SINSIN HANBANG FLEXCAMPHOR, MENTHOLSinsin Pharmaceutical co., ltd.525c5d18-bfc1-3002-e063-6394a90a5b1d2026-05-21WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEPreferred Pharmaceuticals Inc.6c9a076e-6316-427b-9ce6-c8fe2d3888372026-05-21WarningsExact identifier
application number: M017
Medi-First Capsaicin CreamCAPSAICINUnifirst First Aid Corporation49eb807b-fa31-3d84-e063-6394a90acfcf2026-05-20WarningsExact identifier
application number: M017
Biofreeze Triple Target Roll-OnCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC5089c088-3026-233a-e063-6394a90a93b62026-05-19WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP522f1521-f9f2-4c26-e063-6394a90a9e052026-05-19WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin Roll onCAPSAICIN 0.1%Easment LLC521212d6-57fd-4a7a-e063-6294a90a2a182026-05-18WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEWALMART INC.15af4557-4baf-c177-e063-6294a90a7a5b2026-05-18WarningsExact identifier
application number: M017
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
application number: M017
Tiger BalmCAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.5066dc10-e4d5-49e9-9a5f-0ac220cfbf282026-05-18WarningsExact identifier
application number: M017
Deep Blue MiniMENTHOLdoTERRA International, LLC51dd58a8-1fd5-9cd7-e063-6394a90a1f722026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight GelMENTHOLReckitt Benckiser LLCf5c8c08b-c7c0-f84d-e053-2a95a90add152026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654726menthol 14.5 % / methyl salicylate 30 % Topical SolutionPSN5e02fbe3-5bc7-430e-b661-3a760ddd8fe04
1654726menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical SolutionSCD5e02fbe3-5bc7-430e-b661-3a760ddd8fe04
1654726menthol 14.5 % / methyl salicylate 30 % Topical SolutionSY5e02fbe3-5bc7-430e-b661-3a760ddd8fe04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43405-010-01434050010011 BOTTLE, GLASS in 1 BOX (43405-010-01) / 85 mL in 1 BOTTLE, GLASS (43405-010-85) 2015-06-150000-00-00NoNoCurrent
43405-010-854340500108585 mL in 1 BOTTLE, GLASS85 mlHistorical