Home NDC 52261-4902 ASYSTEM Radical Relief Gel Roll-On
Product NDC 52261-4902
11-digit product format 522614902
Labeler code 52261
Product ID 52261-4902_a3703ccc-6a71-4d83-85e7-c1f4f86c79be
Type HUMAN OTC DRUG
Nonproprietary name Menthol, Methyl Salicylate
Dosage form GEL
Route TOPICAL
Labeler Cosco International, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-03
Substance MENTHOL; METHYL SALICYLATE
Active strength .1; .15 kg/kg; kg/kg
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 ASYSTEM Radical Relief Gel Roll-On
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .1 kg/kg METHYL SALICYLATE .15 kg/kg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 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 282810 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 52261-4902-1 ASYSTEM Radical Relief Gel Roll-On 0.075 kg in 1 BOTTLE, WITH APPLICATOR GEL 0.075 3 52261-4902-1 ASYSTEM Radical Relief Gel Roll-On 1 in 1 CARTON GEL 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52261-4902 ASYSTEM RADICAL RELIEF GEL ROLL-ON (MENTHOL, METHYL SALICYLATE) GEL [COSCO INTERNATIONAL, INC.] 2 Current NDC, 2 package rows 20240906_7239733e-5510-4a63-96c3-dd88b4a431a3.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 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 52261-4902-1 52261490201 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52261-4902-1) / .075 kg in 1 BOTTLE, WITH APPLICATOR 2023-07-03 No No Current