Home NDC 27854-499 FLANAX
Product NDC 27854-499
11-digit product format 278540499
Labeler code 27854
Product ID 27854-499_1cadd0fb-dd05-4b32-ae8e-c3e3d73137db
Type HUMAN OTC DRUG
Nonproprietary name Methyl Salicylate, Menthol, Capsaicin
Dosage form LINIMENT
Route TOPICAL
Labeler Belmora LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-01
Substance METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAPSAICIN
Active strength 28; 10; .003 g/100g; g/100g; g/100g
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 FLANAX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 28 g/100g MENTHOL, UNSPECIFIED FORM 10 g/100g CAPSAICIN .003 g/100g
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 L7T10EIP3A Internal UNII lookup S07O44R1ZM Internal UNII 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 27854-499-01 FLANAX 1 in 1 CARTON LINIMENT 1 1 27854-499-01 FLANAX 28.35 g in 1 TUBE LINIMENT 28.35 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27854-499 FLANAX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LINIMENT [BELMORA LLC] 1 Current NDC, 2 package rows 20241212_5e06c688-a086-4c1c-8dab-fcead61fef40.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 151 · 3,020 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 27854-499-01 27854049901 1 TUBE in 1 CARTON (27854-499-01) / 28.35 g in 1 TUBE 1 tube 2024-08-01 No No Current