Home NDC 60954-005 Eagle Medicated Oil
Product NDC 60954-005
11-digit product format 609540005
Labeler code 60954
Product ID 60954-005_23da2b09-f7f1-57d7-e063-6394a90a8713
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 2022-06-20
Substance METHYL SALICYLATE; MENTHOL
Active strength 15; 14 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 Medicated Oil
Brand name suffix Refreshing
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 15 g/100mL MENTHOL 14 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LAV5U5022Y Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2560737 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60954-005-03 Eagle Medicated OilRefreshing 1 in 1 BOX OIL 1 2 60954-005-03 Eagle Medicated OilRefreshing 3 mL in 1 BOTTLE, GLASS OIL 3 2 60954-005-08 Eagle Medicated OilRefreshing 8 mL in 1 BOTTLE, GLASS OIL 8 2 60954-005-08 Eagle Medicated OilRefreshing 1 in 1 BOX OIL 1 2 60954-005-12 Eagle Medicated OilRefreshing 1 in 1 BOX OIL 1 2 60954-005-12 Eagle Medicated OilRefreshing 12 mL in 1 BOTTLE, GLASS OIL 12 2 60954-005-24 Eagle Medicated OilRefreshing 1 in 1 BOX OIL 1 2 60954-005-24 Eagle Medicated OilRefreshing 24 mL in 1 BOTTLE, GLASS OIL 24 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60954-005 EAGLE MEDICATED OIL REFRESHING (MENTHOL, METHYL SALICYLATE) OIL [EAGLE INDO PHARMA, PT] 2 Current NDC, Legacy NDC, 8 package rows 20241008_e2729023-d689-7ae2-e053-2a95a90a78dc.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 145 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AMINO ACTIVE Topical Analgesic Cream HISTAMINE DIHYDROCHLORIDE VIREO SYSTEMS, INC. 591b1e7e-a8c0-4640-a592-4e0f3538a40e 2023-11-11 Warnings Exact identifier application number: M017 NERVE ACTIVE Pain Relief Cream MENTHOL TOP DOG DIRECT, LLC a8b85dcb-fd3e-4340-a945-609fc741443c 2023-11-11 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back LIDOCAINE Geri-Gentle Corporation e4427928-c063-9ca6-e053-2995a90a1aa1 2023-11-10 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch Arm and Neck MENTHOL Geri-Gentle Corporation e4429f70-667e-662b-e053-2a95a90a62ba 2023-11-10 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch Back MENTHOL Geri-Gentle Corporation e442b8ec-a3de-65e8-e053-2995a90af3ec 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 9f948fb4-4275-4a1f-83f8-cd708db4a296 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF PAIN RELIEF MENTHOL BLUE SPRING WELLNESS, L.L.C. b4278b70-e9a6-4d1f-bbad-257fe437b86a 2023-11-10 Warnings Exact identifier application number: M017 BLUE SPRING Foot and Leg Comfort Cream with Pain Relief MENTHOL, CAPSAICIN BLUE SPRING WELLNESS, L.L.C. 2f9cf514-48be-49ec-b424-0b228b4b874a 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 1231ddd2-7661-45b2-ab15-32f7fdc078a8 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE Stuff Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 7779b26b-ae3b-4639-a6b0-826c7ab37a86 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE Theraplex Solutions a898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d4 2023-11-10 Warnings Exact identifier application number: M017 SUPER BLUE STUFF Pain Relief Cream MENTHOL BLUE SPRING WELLNESS, L.L.C. 066a2106-2e25-4df6-9a8d-4417ba190205 2023-11-10 Warnings Exact identifier application number: M017 INVIGO FLEX Pain Relief Gel MENTHOL WYNNPHARM INC. 909e1d8c-c517-4d6a-8682-894f042c00f8 2023-11-10 Warnings Exact identifier application number: M017 ARNIMAX Penetrating Pain Relief Gel MENTHOL WYNNPHARM INC. 3a31f805-19c6-4036-a663-ebef9b212007 2023-11-10 Warnings Exact identifier application number: M017 KERA HC HYDROCORTISONE Clinical Therapeutic Solutions ac215c8f-b224-480c-9295-3a34316293ba 2023-11-10 Warnings Exact identifier application number: M017 ALO THERAPEUTIC MASSAGE PAIN RELIEVING MENTHOL, HISTAMINE DIHYDROCHLORIDE Theraplex Solutions da004500-5e48-487b-b96f-520a3094096c 2023-11-10 Warnings Exact identifier application number: M017 Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING MENTHOL, METHYL SALICYLATE Rexall Sundown, LLC 55c55f1c-d2b3-6363-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 NEUROFLEX Topical Pain Relieving Liquid CAMPHOR (SYNTHETIC), MENTHOL Almark Products Inc 6da3aa84-7a01-4041-8792-a4bbf49e6e4e 2023-11-10 Warnings Exact identifier application number: M017 SMOOTH GATOR 60-second Pain Relief CAMPHOR (SYNTHETIC), MENTHOL Smooth Gator LLC 3b74b542-202f-469e-8025-4372e95e6b01 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f8b8d1-a20b-54b0-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60954-005-03 60954000503 1 BOTTLE, GLASS in 1 BOX (60954-005-03) / 3 mL in 1 BOTTLE, GLASS 2022-06-20 0000-00-00 No No Current 60954-005-08 60954000508 1 BOTTLE, GLASS in 1 BOX (60954-005-08) / 8 mL in 1 BOTTLE, GLASS 2022-06-20 0000-00-00 No No Current 60954-005-12 60954000512 1 BOTTLE, GLASS in 1 BOX (60954-005-12) / 12 mL in 1 BOTTLE, GLASS 2022-06-20 0000-00-00 No No Current 60954-005-24 60954000524 1 BOTTLE, GLASS in 1 BOX (60954-005-24) / 24 mL in 1 BOTTLE, GLASS 2022-06-20 0000-00-00 No No Current