Home NDC 43405-098 Eagle Brand
Product NDC 43405-098
11-digit product format 434050098
Labeler code 43405
Product ID 43405-098_567b6820-fb53-630e-e063-6294a90a8bf8
Type HUMAN OTC DRUG
Nonproprietary name camphor, menthol
Dosage form OIL
Route TOPICAL
Labeler Borden Company (Private) Limited
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-07-01
Substance PEPPERMINT OIL; CAMPHOR (SYNTHETIC)
Active strength 12.18; 1.91 g/100mL; g/100mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
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 PEPPERMINT OIL 12.18 g/100mL CAMPHOR (SYNTHETIC) 1.91 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AV092KU4JH Internal UNII lookup 5TJD82A1ET Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 43405-098-08 43405009808 1 BOTTLE, GLASS in 1 BOX (43405-098-08) / 8 mL in 1 BOTTLE, GLASS 2015-07-01 No No Current