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 12 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natures Willow Balm Roll On Pain ReliefMENTHOLWB Ventures LLC3b1834e6-75cd-5380-e063-6294a90ad1d52026-07-08WarningsExact identifier
application number: M017
Natures Willow Balm Itch Relief CreamMENTHOLWB Ventures LLC0ce31b5d-4401-460c-e063-6394a90ab5582026-07-08WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.560a4abf-31dd-333f-e063-6294a90a35052026-07-08WarningsExact identifier
application number: M017
Natures Willow BalmMENTHOLWB VENTURES LLCb9f50c43-b0d5-39a8-e053-2995a90a04f12026-07-08WarningsExact identifier
application number: M017
Natures Willow Bug Bite BalmMENTHOLWB Ventures LLCb9fab18f-32c7-d5bd-e053-2995a90a6d0f2026-07-08WarningsExact identifier
application number: M017
Salonpas pain relieving hotCAPSAICIN, MENTHOLHisamitsu Pharmaceutical Co., Inc.d2aa8820-a947-404b-b617-e692fbd165022026-07-07WarningsExact identifier
application number: M017
Quali Yi Tiao Gen Pain PatchCAPSAICIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory33154a9b-f6d0-4e95-b4cb-6b938f5dcf4d2026-07-07WarningsExact identifier
application number: M017
MUYOHON Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.55caf0a5-f062-a6c3-e063-6294a90ae0732026-07-04WarningsExact identifier
application number: M017
Targeted Warming Capsaicin PatchCAPSAICINArmy & Air Force Exchange Service55b539f8-38c4-594e-e063-6394a90afbaa2026-07-03WarningsExact identifier
application number: M017
TopCare Health Pain ReliefLIDOCAINE HYDROCHLORIDETopco Associates LLC485b0671-da09-19d7-e063-6294a90aca5d2026-07-03WarningsExact identifier
application number: M017
Mineral Ice Methol Pain ReliefMENTHOL 10.5 %Sunflora Inc6ddd9e97-f717-4d5a-9658-26449a3cc8312026-07-02WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEAmerisourceBergen Drug Corporation7d898e33-ded7-c9b9-e053-2a91aa0adf7c2026-07-01WarningsExact identifier
application number: M017
Desert Harvest Releveum with LidocaineLIDOCAINE HYDROCHLORIDEDesert Harvest, Inc9ad514ab-a6bd-4564-8ba3-0149032ebf362026-07-01WarningsExact identifier
application number: M017
CVS No Mess CortisoneHYDROCORTISONENatural Essentials, Inc.558c94ec-95f1-eb98-e063-6394a90a1e722026-07-01WarningsExact identifier
application number: M017
MUSCLE EASEMENTHOL CAMPHORSOMBRA COSMETICS INC.03fff4bf-04ed-49a6-b40f-4d98c2b42f692026-07-01WarningsExact identifier
application number: M017
OrthoNesic Pain Relieving GelMENTHOL, CAMPHORBlaine Labs Inc.122f60c2-f8df-4625-8bb8-a2244a261b5d2026-07-01WarningsExact identifier
application number: M017
Desert Harvest RELEVEUMLIDOCAINEDesert Harvest Inc.5d9010ec-d482-44ff-ba27-3bfec5a241c62026-06-30WarningsExact identifier
application number: M017
PromescentLIDICAINEAbsorption5b508238-3be7-4b0d-bf35-51de79f58f552026-06-30WarningsExact identifier
application number: M017
LidovyxLIDOCAINE 4%V2 Pharma LLC4465eb60-a617-4608-9504-8b3b4c64f49e2026-06-30WarningsExact identifier
application number: M017
Dr.Johnes Lidocaine 4% Topical Analgesic CreamLIDOCAINE HCL,MENTHOLDr.Johnes LLC6144708d-4b0f-4f0d-88e3-6925ba2d004d2026-06-29WarningsExact 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