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 129 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch and Rash CreamHYDROCORTISONEWildman Business Group1f95757d-a434-f02a-e063-6294a90a2d122024-09-01WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEWildman Business Group1fd1a4b3-b6fd-0d4c-e063-6394a90a36802024-09-01WarningsExact identifier
application number: M017
Thera Care Cold Hot Medicated PatchMENTHOLVeridian Healthcareb1ce129d-06a1-7755-e053-2995a90abd7d2024-08-29WarningsExact identifier
application number: M017
BIOSAVIA External Analgesic Pain ReliefCAPSAICINBIOSAVIA USA, LLC814aa66b-7719-4a29-a84e-18290367e9c72024-08-28WarningsExact identifier
application number: M017
Careland Plantar Fasciitis Hydrogel Pain PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.0e2f29c2-2e95-4be0-b7e9-f1761a1321a52024-08-21WarningsExact identifier
application number: M017
Careland Max Strength Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.265b8dd7-64a4-4bc2-a91c-26c761c2090b2024-08-21WarningsExact identifier
application number: M017
Real Time Pain Relief Maxx Topical AnalgesicMENTHOLREAL TIME PRODUCTS, INCf45eb95a-2813-4124-bdb0-54e078a8237d2024-08-20WarningsExact identifier
application number: M017
Theracare Lidocaine Pain reliefLIDOCAINEVeridian Healthcare1d8a3679-637d-94c0-e063-6294a90a9ecf2024-08-19WarningsExact identifier
application number: M017
LidoSyncLIDOCAINE, MENTHOLiON Pharma, LLC200f883c-439a-3b99-e063-6394a90aed102024-08-19WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited09243a23-1f17-f77b-e063-6394a90a0b222024-08-19WarningsExact identifier
application number: M017
CVS Health Maximum Strength Scalp Relief Anti-itchHYDROCORTISONECVS Healthb5ef0005-8b76-4205-8be0-db3a7ed7d1c42024-08-19WarningsExact identifier
application number: M017
Rite Aid Pain Relieving Roll-OnLIDOCAINE HCLRite Aid Corporation1406590c-667c-84eb-e063-6294a90a50522024-08-16WarningsExact identifier
application number: M017
NuviraCAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10%Strand Health Groupff448183-03cf-df2d-e053-6394a90a77f02024-08-16WarningsExact identifier
application number: M017
FLANAXMETHYL SALICYLATE, MENTHOL, CAPSAICINBelmora LLC5e06c688-a086-4c1c-8dab-fcead61fef402024-08-13WarningsExact identifier
application number: M017
Pain ReliefMENTHOLPain Relieving Spray Inc.1f44466f-044f-70fe-e063-6294a90ad5752024-08-09WarningsExact identifier
application number: M017
Meijer Cold Therapy Pain RelievingMENTHOLMeijer Inc1c5b55e3-f859-71b6-e063-6294a90a633b2024-08-08WarningsExact identifier
application number: M017
HealthWise Soothing Cold Therapy GelMENTHOL 4%Veridian Healthcare1f09ccdd-09d8-6a8d-e063-6394a90a184f2024-08-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.fbbbcc67-b46d-d41a-e053-6294a90aa55d2024-08-08WarningsExact identifier
application number: M017
Cheezheng Pain Relief CreamMENTHOLTibet Cheezheng Tibetan Medicine Co. Ltd37279a3f-9207-4e4c-90d6-52735044f1042024-08-07WarningsExact identifier
application number: M017
CVS Health Hydrocortisone Anti ItchHYDROCORTISONECVS Health546a1b8a-8254-432a-85c4-38ebee5ad5682024-08-07WarningsExact 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