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 51 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Certain Dri Clinical Strength Prescription Protection RollonCERTAIN DRI CLINICAL STRENGTH PRESCRIPTION PROTECTION ROLLONClarion Brands LLC46a1f92e-4411-3989-e063-6394a90a70382025-12-23WarningsExact identifier
application number: M017
PREMIERES PAINMENTHOLPremiere Enterprises128bd1e7-e961-416c-933b-fbd146e3d3862025-12-23WarningsExact identifier
application number: M017
PREMIERES PAINMENTHOLPremiere Enterprises35ff19df-4cc4-4fce-bd30-d87d835e0e262025-12-23WarningsExact identifier
application number: M017
Premieres PainMENTHOLPremiere Enterprises1f081913-6106-4d06-a37a-631f710dbacb2025-12-23WarningsExact identifier
application number: M017
ABSORBINE jr.LIDOCAINE HCL, PHENOLClarion Brands, LLCe1de73bb-917c-48d1-9a78-00c76edddb982025-12-23WarningsExact identifier
application number: M017
ABSORBINE jr. PLUS KneeCAMPHOR, MENTHOLClarion Brands, LLC3ad8718d-ebf1-474f-8a91-48c78ab3b5c12025-12-23WarningsExact identifier
application number: M017
Absorbine Jr. PlusMENTHOLClarion Brands, LLCfd5d77fc-dc73-2aec-2c7f-0fca5d7d3a752025-12-23WarningsExact identifier
application number: M017
ABSORBINE JR PLUS ULTRA STRENGTH PAINMENTHOLClarion Brands, LLCcf329707-d90a-29dd-f2c2-acfd5af614f32025-12-23WarningsExact identifier
application number: M017
Absorbine Jr Pro CreamLIDOCAINE HCL, PHENOLClarion Brands, LLC17b3f1e6-5554-4f3e-b133-76ae8ffea9192025-12-23WarningsExact identifier
application number: M017
Absorbine Jr Pro No Mess Roll-on PlusLIDOCAINE HCL, PHENOLClarion Brands, LLCa7172f17-1525-4738-b72c-92479c730af22025-12-23WarningsExact identifier
application number: M017
ABSORBINE JRMENTHOLClarion Brands, LLCd656e7f6-ca26-1873-6c11-08aa82091bb02025-12-23WarningsExact identifier
application number: M017
Relief RecoveryMETHYL SALICYLATEMayway Corporation27afd45e-2dc5-d099-e063-6394a90ad2b72025-12-23WarningsExact identifier
application number: M017
MobilityMETHYL SALICYLATEMayway Corporation27af9d17-9c15-5e2a-e063-6394a90aeda52025-12-23WarningsExact identifier
application number: M017
medlot pain relief gel patchLIDOCAINELotfancy, Inc.3ce4af20-b227-5b98-e063-6394a90ab9922025-12-23WarningsExact identifier
application number: M017
Nizoral Scalp Itch ReliefHYDROCORTISONEKramer Laboratoriesdba59238-6beb-447e-8c4c-e4bc00fd2c202025-12-23WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu America, Inc.63911880-8194-4c7d-a72f-cab94761b2d72025-12-23WarningsExact identifier
application number: M017
The Body Builders CreamMENTHOLSmart Cookie Solutionsf803325e-eb86-4b9e-a401-0a91bdcd63892025-12-22WarningsExact identifier
application number: M017
PROINNATE Numbing CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd46895ddb-0b9f-675e-e063-6394a90adf232025-12-22WarningsExact identifier
application number: M017
Caring Mills Vaginal Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcaref2362658-aea2-438e-a66c-738022e6e0472025-12-22WarningsExact identifier
application number: M017
HealthWise Pain Relieving Menthol GelMENTHOL 2%Veridian Healthcare396d0fd4-67be-4de1-8f0c-42c83dfe91202025-12-22WarningsExact 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