FDA.reportPublic FDA data

Eagle

Product NDC
60954-002
11-digit product format
609540002
Labeler code
60954
Product ID
60954-002_23dc3449-3f69-289c-e063-6394a90ab1f1
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol Methyl Salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Eagle Indo Pharma, PT
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
2026-12-31
Current FDA listing
Yes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-002-03EagleMedicated3 mL in 1 BOTTLE, GLASSOIL33
60954-002-03EagleMedicated1 in 1 BOXOIL13
60954-002-24EagleMedicated1 in 1 BOXOIL13
60954-002-24EagleMedicated24 mL in 1 BOTTLE, GLASSOIL243
60954-002-36EagleMedicated1 in 1 BOXOIL13
60954-002-36EagleMedicated36 mL in 1 BOTTLE, GLASSOIL363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-002EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [EAGLE INDO PHARMA, PT]3Current NDC, Legacy NDC, 6 package rows20241009_da338796-de9c-be51-e053-2a95a90a2509.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSNda338796-de9c-be51-e053-2a95a90a25093
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSNda338796-de9c-be51-e053-2a95a90a25093
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBDda338796-de9c-be51-e053-2a95a90a25093
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCDda338796-de9c-be51-e053-2a95a90a25093
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSYda338796-de9c-be51-e053-2a95a90a25093
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSYda338796-de9c-be51-e053-2a95a90a25093
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSYda338796-de9c-be51-e053-2a95a90a25093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60954-002-03609540002031 BOTTLE, GLASS in 1 BOX (60954-002-03) / 3 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent
60954-002-24609540002241 BOTTLE, GLASS in 1 BOX (60954-002-24) / 24 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent
60954-002-36609540002361 BOTTLE, GLASS in 1 BOX (60954-002-36) / 36 mL in 1 BOTTLE, GLASS2022-03-040000-00-00NoNoCurrent