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
IngredientStrength
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
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
282810Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7239733e-5510-4a63-96c3-dd88b4a431a3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-4902-1ASYSTEM Radical Relief Gel Roll-On0.075 kg in 1 BOTTLE, WITH APPLICATORGEL0.0753
52261-4902-1ASYSTEM Radical Relief Gel Roll-On1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-4902ASYSTEM RADICAL RELIEF GEL ROLL-ON (MENTHOL, METHYL SALICYLATE) GEL [COSCO INTERNATIONAL, INC.]2Current NDC, 2 package rows20240906_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 94 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Stop Itch GelDIPHENHYDRAMINE HCLWalgreens Co23586336-8f46-3dcd-e063-6394a90accc92025-05-04WarningsExact identifier
application number: M017
WaxRx EarAcheRx Pain Relieving Drops4% LIDOCAINE HCLDOCTOR EASY MEDICAL PRODUCTS, LLC34156655-8706-f0a4-e063-6294a90acc902025-05-01WarningsExact identifier
application number: M017
foster and thrive anti itch creamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEStrategic Sourcing Services LLCbb08293d-5db8-4cc8-9fe3-bd02061dbeb92025-04-30WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINESolis Pharmaceuticals Inc.3061d301-2104-b1b2-e063-6394a90a9b6e2025-04-29WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINEInterMed Laboratories Private Limited33ed754e-8852-d5b2-e063-6394a90a7cf22025-04-29WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee6e48-243e-4ded-e063-6394a90a987d2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd32b96689-8e9b-4c2e-e063-6294a90a7d1c2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3304e362-dcda-3f5e-e063-6294a90a70152025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd2f2f753d-c791-e863-e063-6394a90aec5d2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3162c96a-061d-2971-e063-6394a90a9b742025-04-29WarningsExact identifier
application number: M017
Ivarest Poison Ivy Removal and Itch ReliefPRAMOXINE HYDROCHLORIDEBlistex Inc.dedbf5d9-0f86-4f32-8321-da86c9838c0a2025-04-29WarningsExact identifier
application number: M017
HealthWise 2X Medicated Pain Relief Cream Roll-onMENTHOLVeridian Healthcare33dae8a8-4197-f276-e063-6294a90aea832025-04-28WarningsExact identifier
application number: M017
HealthWise Roll-on Menthol Pain Relief GelMENTHOLVeridian Healthcare33dbb939-9397-7e70-e063-6294a90ac8f42025-04-28WarningsExact identifier
application number: M017
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.fa1a98bc-c233-410d-a20e-71111c8973722025-04-28WarningsExact identifier
application number: M017
Lidocaine Patch 4%LIDOCAINE 4%Medcore LLCb961906c-fe66-466b-af2c-072781fa098b2025-04-28WarningsExact identifier
application number: M017
Walgreens Lidocaine Knee and ElbowLIDOCAINEWalgreen Co.a3fb4c78-1493-4ba4-ae83-502dd825ed672025-04-25WarningsExact identifier
application number: M017
Walgreens Lidocaine BackLIDOCAINEWalgreen Co.e6bfd342-c0db-46b9-b5e6-5acbd860adf12025-04-25WarningsExact identifier
application number: M017
Electrum Numb FoamLIDOCAINE HCIRENU LABORATORIES, LLCc8472932-28b7-9189-e053-2a95a90a44df2025-04-25WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC66a2fd60-1757-45cc-a195-ecb9241dca2a2025-04-24WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.3385cddb-609f-62e8-e063-6294a90add812025-04-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282810menthol 10 % / methyl salicylate 15 % Topical GelPSN7239733e-5510-4a63-96c3-dd88b4a431a33
282810menthol 0.1 MG/MG / methyl salicylate 0.15 MG/MG Topical GelSCD7239733e-5510-4a63-96c3-dd88b4a431a33
282810menthol 10 % / methyl salicylate 15 % Topical GelSY7239733e-5510-4a63-96c3-dd88b4a431a33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
52261-4902-1522614902011 BOTTLE, WITH APPLICATOR in 1 CARTON (52261-4902-1) / .075 kg in 1 BOTTLE, WITH APPLICATOR2023-07-03NoNoCurrent