Home NDC 50488-1016 Methyl Salicylate 25 Percent
Product NDC 50488-1016
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 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 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 132 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Genuine First Aid Alcohol Cleansing Pad BENZOCAINE, ALCOHOL GFA Production (Xiamen) Co., Ltd. c39c4d80-9718-459f-8ae4-ada043bba5b7 2024-06-26 Warnings Exact identifier application number: M017 Eagle Brand Medicated Roll On MENTHOL, METHYL SALICYLATE PT. EAGLE INDO PHARMA 1bd5cf69-9a08-5e2e-e063-6394a90a03cd 2024-06-26 Warnings Exact identifier application number: M017 Solarcaine Burn Pain Relief 4oz SOLARCAINE BURN PAIN RELIEF 4OZ WellSpring Pharmaceutical Corporation 2c0389db-ceb2-422b-9575-bdb8fe649a1e 2024-06-26 Warnings Exact identifier application number: M017 astonea HYDROCORTISONE ASTONEA LABS PRIVATE LIMITED de09e859-c5fd-0cc5-e053-2a95a90a147e 2024-06-25 Warnings Exact identifier application number: M017 HealthWise Pain Relief Lidocaine Patch LIDOCAINE 4% Veridian Healthcare 0190196d-5f78-042b-e063-6294a90a3714 2024-06-25 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil MENTHOL, METHYL SALICYLATE PT. EAGLE INDO PHARMA 1bc1bf83-91ee-ec9d-e063-6394a90a3daf 2024-06-25 Warnings Exact identifier application number: M017 Eagle Brand Medicated Roll On MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 1bc2f688-d0c4-690e-e063-6294a90abc38 2024-06-25 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 1b9fdac0-9fb0-e669-e063-6394a90aece9 2024-06-24 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN Asclemed USA, Inc. 97d506bd-3215-4e2e-9914-af1c174dd4ab 2024-06-20 Warnings Exact identifier application number: M017 ABREVA Rapid Pain Relief GLYCERIN, LIDOCAINE Haleon US Holdings LLC 65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d 2024-06-20 Warnings Exact identifier application number: M017 Frankie Avalons ZERO PAIN Roll-On Pain Reliever CAPSAICIN WHY ENTERPRISES LLC e32acb5f-5bc3-4228-b037-6315d080f556 2024-06-17 Warnings Exact identifier application number: M017 PUREGEN LABS Pain Relief 4 Lidocaine LIDOCAINE Advanced Rx LLC 9dff40d8-8d7e-4629-bea5-987f5e68477d 2024-06-11 Warnings Exact identifier application number: M017 SMOOTH GATOR Head-Ezz Analgesic MENTHOL Smooth Gator LLC 02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd 2024-06-10 Warnings Exact identifier application number: M017 FIRST AID BURN LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE Epic Medical Supply Corp bd1b1873-e900-45eb-96a0-28f782b5a7cd 2024-06-04 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Chain Drug Marketing Association Inc. 1c834ba0-86b6-8e61-e063-6394a90a192d 2024-06-04 Warnings Exact identifier application number: M017 HealthWise Feminine Anti-itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare 19fe7c3b-58e2-6c16-e063-6394a90a612a 2024-06-03 Warnings Exact identifier application number: M017 THE SOLUTION NUMBING LIDOCAINE HYDROCHLORIDE SCALP TECH INC 184be4cc-b0b9-7882-e063-6394a90a8e7e 2024-05-25 Warnings Exact identifier application number: M017 Methyl Salicylate 25 Percent METHYL SALICYLATE Alexso, Inc d8b8b0ba-69e9-4965-bf9b-6db21db69b34 2024-05-23 Warnings Exact identifier application number: M017 ndc (product): 50488-1016 Meijer Medicated Chest Rub CAMPHOR, MENTHOL, EUCALYPTUS OIL Meijer Distribution 07ecc6a7-bbe3-35cf-e063-6394a90a2180 2024-05-22 Warnings Exact identifier application number: M017 TheraCare Hydrocortisone Cream HYDROCORTISONE Veridian Healthcare 01cb7b47-2c3c-707d-e063-6294a90a5d97 2024-05-21 Warnings Exact identifier application number: M017
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