FDA.reportPublic FDA data

Eagle

Product NDC
43405-006
11-digit product format
434050006
Labeler code
43405
Product ID
43405-006_238a76dd-0b55-474d-e063-6394a90a65a0
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
d9a93daa-4e24-6690-e053-2a95a90a147cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-006-03EagleMedicated1 in 1 BOXOIL13
43405-006-03EagleMedicated3 mL in 1 BOTTLE, GLASSOIL33
43405-006-24EagleMedicated24 mL in 1 BOTTLE, GLASSOIL243
43405-006-24EagleMedicated1 in 1 BOXOIL13
43405-006-36EagleMedicated36 mL in 1 BOTTLE, GLASSOIL363
43405-006-36EagleMedicated1 in 1 BOXOIL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-006EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED]3Current NDC, Legacy NDC, 6 package rows20241004_d9a93daa-4e24-6690-e053-2a95a90a147c.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 118 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEPatrin Pharma Inc.91eedf9d-53b8-49d5-af59-25019606a0b22024-11-15WarningsExact identifier
application number: M017
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFId1ac686e-62f2-4177-8abc-8c7ca578de1a2024-11-15WarningsExact identifier
application number: M017
Meijer Pain Relieving Max Strength with Lavender Essential Oil AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Ince688967e-799a-4fc8-a19a-f0012b90e76b2024-11-15WarningsExact identifier
application number: M017
basic care hydrocortisoneHYDROCORTISONEAmazon.com Services LLCa0d0e82b-03ff-4d43-9be0-0e414ee499702024-11-15WarningsExact identifier
application number: M017
DG health hydrocortisoneHYDROCORTISONEDolgencorp, LLC40710bae-32bb-47fd-b3dd-31d2c98ee70f2024-11-15WarningsExact identifier
application number: M017
Meijer Ultra Strength Pain Relieving Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEMeijer Distribution, Inc6319b019-8e17-4de1-b4e0-b402288a97d42024-11-15WarningsExact identifier
application number: M017
Meijer Pain Relieving analgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc9953be94-5768-448f-83de-f5e53a2972cc2024-11-15WarningsExact identifier
application number: M017
careone anti itchHYDROCORTISONEAmerican Sales Company5f7b1435-ebee-4093-847a-79e8d66414042024-11-15WarningsExact identifier
application number: M017
Tiger BalmMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.51293a06-5922-4072-ae14-afaba9c1b58e2024-11-14WarningsExact identifier
application number: M017
Tylenol Precise Warming Pain RelievingLIDOCAINEKenvue Brands LLC0c60b607-ade9-68f2-e063-6394a90a40252024-11-13WarningsExact identifier
application number: M017
Tylenol Precise Pain RelievingLIDOCAINEKenvue Brands LLCfc1e0451-8c84-729e-e053-6394a90aaba02024-11-13WarningsExact identifier
application number: M017
Neosporin Plus Pain Relief First Aid Antibiotic/Pain RelievingNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC23222e54-d793-4d79-980e-550e32a957422024-11-13WarningsExact identifier
application number: M017
TopCare Pain Relieving Roll-On Topical AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLC48589893-ca67-471d-88bc-92014295ab9f2024-11-13WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa1c1b878-d58f-41ff-b7a8-477f28c526672024-11-12WarningsExact identifier
application number: M017
Real Time Pain Relief Maxx Plus Topical AnalgesicMENTHOLReal Time Products Inc.fc509a55-594d-4d44-87db-33286e9375812024-11-12WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAcme United Corporationf1f051ad-7e82-9d1a-e053-2a95a90ac7d32024-11-12WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEALLIED TRADE LINK LLC26bc238d-3bda-0c29-e063-6394a90a35fb2024-11-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAcme United Corporationfabcaa3b-d189-bd29-e053-6294a90ae86b2024-11-12WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP8414aea2-52b5-4221-e053-2a91aa0a622e2024-11-12WarningsExact identifier
application number: M017
Pain Relieving Gel-PatchLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.26c7116f-c86d-8752-e063-6294a90ab73f2024-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSNd9a93daa-4e24-6690-e053-2a95a90a147c3
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSNd9a93daa-4e24-6690-e053-2a95a90a147c3
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBDd9a93daa-4e24-6690-e053-2a95a90a147c3
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCDd9a93daa-4e24-6690-e053-2a95a90a147c3
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSYd9a93daa-4e24-6690-e053-2a95a90a147c3
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSYd9a93daa-4e24-6690-e053-2a95a90a147c3
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSYd9a93daa-4e24-6690-e053-2a95a90a147c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43405-006-03434050006031 BOTTLE, GLASS in 1 BOX (43405-006-03) / 3 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent
43405-006-24434050006241 BOTTLE, GLASS in 1 BOX (43405-006-24) / 24 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent
43405-006-36434050006361 BOTTLE, GLASS in 1 BOX (43405-006-36) / 36 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent