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 115 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Serum X LIDOCAINE HYDROCHLORIDE AO Biologix, LLC e07b6268-6400-6849-e053-2a95a90a8b3e 2024-12-11 Warnings Exact identifier application number: M017 PlusCBD Pain Cream (Penetrating) 2oz CAMPHOR, MENTHOL CV Sciences, Inc. ca39d327-6bf3-3408-e053-2a95a90af2d5 2024-12-11 Warnings Exact identifier application number: M017 Blistex Medicated DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL Blistex Inc. e95439d3-f12b-4c1c-999a-79f2ddba4cfb 2024-12-11 Warnings Exact identifier application number: M017 Blistex Foille Medicated First Aid BENZOCAINE AND CHLOROXYLENOL Blistex Inc. e2eca808-e97b-43e0-aa51-7025cc61c7a8 2024-12-11 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE J&A Digital Inc. ff95a536-35b3-4006-b43c-cce359e86aa9 2024-12-10 Warnings Exact identifier application number: M017 TheraCare Maximum Strength Pain Relief Patch LIDOCAINE Veridian Healthcare dfaf8a77-2276-4791-e053-2a95a90a3288 2024-12-10 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE Alexso, Inc eef555d3-f23d-4847-93f3-fa7a06072a0f 2024-12-09 Warnings Exact identifier application number: M017 Lidocaine 4 Percent LIDOCAINE SA3, LLC 651710db-3c50-4bcf-b7cc-9ed24f663427 2024-12-09 Warnings Exact identifier application number: M017 HealthWise Pain Relief Lidocaine Patch LIDOCAINE 4% Veridian Healthcare 28db1c03-d01f-83ea-e063-6294a90aee26 2024-12-09 Warnings Exact identifier application number: M017 Joint and Muscle Pain Relief MENTHOL Allure Labs e82f99fd-c2ef-686f-e053-2a95a90a1dc9 2024-12-09 Warnings Exact identifier application number: M017 Tough Love Pain Relieving LIDOCAINE HCL Allure Labs ee8c1a2b-36ef-6fd7-e053-2a95a90a9c01 2024-12-09 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN SA3, LLC 5617e91d-e650-4a0d-8565-b8288ea41c77 2024-12-09 Warnings Exact identifier application number: M017 Medicaine Sting and Bite BENZOCAINE James Alexander Corporation 753e6cbe-31e0-4017-93d0-8b4bf5972f37 2024-12-09 Warnings Exact identifier application number: M017 AUVON Pain Relief Roll-on MENTHOL SHENZHEN YUWEN E-COMMERCE CO., LTD. df239c4d-af6a-41ca-baed-d0788782ce9f 2024-12-08 Warnings Exact identifier application number: M017 AUVON Pain Relief Roll-on LIDOCAINE SHENZHEN YUWEN E-COMMERCE CO., LTD. 8b30f623-6077-4f2e-8fa4-ce4a298953b5 2024-12-08 Warnings Exact identifier application number: M017 QC Medicated anti itch PRAMOXINE HYDROCHLORIDE, MENTHOL Chain Drug Marketing Association b5e41e3a-81df-3a63-e053-2a95a90a5839 2024-12-08 Warnings Exact identifier application number: M017 QC Lidocaine Maximum Strength LIDOCAINE HCL Chain Drug Marketing Association b5e1b1ab-8a95-2d2d-e053-2995a90aea53 2024-12-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN Alexso, Inc 433da27d-04fb-481a-bbb0-874bb72c806a 2024-12-06 Warnings Exact identifier application number: M017 POMG PAIN RELIEF BODY LIDOCAINE POMG LLC 28d7ac46-b27f-43bb-e063-6294a90a93ed 2024-12-06 Warnings Exact identifier application number: M017 Capsaicin 0.1 Percent CAPSAICIN Alexso, Inc 0090ca38-6433-45c4-9453-edf2788c14c6 2024-12-06 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