Home NDC 85477-301 METHYL SALICYLATE 25%
Product NDC 85477-301
11-digit product format 854770301
Labeler code 85477
Product ID 85477-301_38e43dff-f89e-6248-e063-6294a90aaaf1
Type HUMAN OTC DRUG
Nonproprietary name METHYL SALICYLATE
Dosage form CREAM
Route TOPICAL
Labeler Oncora Pharma, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-11
Substance METHYL SALICYLATE
Active strength 250 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 METHYL SALICYLATE 25%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 250 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LAV5U5022Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238542 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 85477-301-10 METHYL SALICYLATE 25% 118 mL in 1 BOTTLE, PUMP CREAM 118 2
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 78 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85477-301-10 85477030110 118 mL in 1 BOTTLE, PUMP (85477-301-10) 118 ml 2025-06-11 No No Current