Home NDC 60954-017 Eagle Brand
Product NDC 60954-017
11-digit product format 609540017
Labeler code 60954
Product ID 60954-017_507be31f-1333-bfd7-e063-6394a90ad92a
Type HUMAN OTC DRUG
Nonproprietary name camphor, menthol, methyl salicylate
Dosage form OIL
Route TOPICAL
Labeler PT. EAGLE INDO PHARMA
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-01
Substance METHYL SALICYLATE; CAMPHOR (SYNTHETIC); MENTHOL
Active strength 35; 7; 16 g/100mL; 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
Brand name suffix Medicated Roll On Aromatic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 35 g/100mL CAMPHOR (SYNTHETIC) 7 g/100mL MENTHOL 16 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LAV5U5022Y Internal UNII lookup 5TJD82A1ET 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 1654728 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60954-017-08 Eagle BrandMedicated Roll On Aromatic 8 mL in 1 BOTTLE, GLASS OIL 8 3 60954-017-08 Eagle BrandMedicated Roll On Aromatic 1 in 1 BOX OIL 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60954-017 EAGLE BRAND MEDICATED ROLL ON AROMATIC (CAMPHOR, MENTHOL, METHYL SALICYLATE) OIL [PT. EAGLE INDO PHARMA] 2 Current NDC, 2 package rows 20250122_0f333f93-bec6-72d5-e063-6394a90a4e3f.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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60954-017-08 60954001708 1 BOTTLE, GLASS in 1 BOX (60954-017-08) / 8 mL in 1 BOTTLE, GLASS 2023-11-01 No No Current