Home NDC 50488-1016-5 Methyl Salicylate 25 Percent
Product NDC 50488-1016
Requested package NDC 50488-1016-5
11-digit product format 504881016
Labeler code 50488
Product ID 50488-1016_78bef856-b769-49ad-89af-8e46966e99ec
Type HUMAN OTC DRUG
Nonproprietary name Methyl Salicylate
Dosage form CREAM
Route TOPICAL
Labeler Alexso, Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-01
Substance METHYL SALICYLATE
Active strength 250 mg/mL
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 Methyl Salicylate 25 Percent
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50488-1016-5 Methyl Salicylate 25 Percent 50 mL in 1 BOTTLE, PUMP CREAM 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50488-1016 METHYL SALICYLATE 25 PERCENT (METHYL SALICYLATE) CREAM [ALEXSO, INC] 1 Current NDC, 1 package rows 20240522_d8b8b0ba-69e9-4965-bf9b-6db21db69b34.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 77 of 152 · 3,029 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 50488-1016-5 50488101605 50 mL in 1 BOTTLE, PUMP (50488-1016-5) 50 ml 2024-05-01 No No Current