Home NDC 60954-012 Eagle Brand
Product NDC 60954-012
11-digit product format 609540012
Labeler code 60954
Product ID 60954-012_507b9495-e9a3-7fba-e063-6394a90a8d84
Type HUMAN OTC DRUG
Nonproprietary name camphor, menthol
Dosage form OIL
Route TOPICAL
Labeler PT. EAGLE INDO PHARMA
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-01
Substance CAMPHOR (SYNTHETIC); MENTHOL
Active strength 2.2; 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 Brand
Brand name suffix Medicated Roll On Refresh
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAMPHOR (SYNTHETIC) 2.2 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 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 2672336 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 60954-012-08 Eagle BrandMedicated Roll On Refresh 1 in 1 BOX OIL 1 2 60954-012-08 Eagle BrandMedicated Roll On Refresh 8 mL in 1 BOTTLE, GLASS OIL 8 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60954-012 EAGLE BRAND MEDICATED ROLL ON REFRESH (CAMPHOR, MENTHOL) OIL [PT. EAGLE INDO PHARMA] 1 Current NDC, 2 package rows 20240102_09235f26-2262-6ca2-e063-6394a90ad8f1.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 60954-012-08 60954001208 1 BOTTLE, GLASS in 1 BOX (60954-012-08) / 8 mL in 1 BOTTLE, GLASS 2023-11-01 No No Current