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 128 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AOSI HEALTHCARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a28b920c-0bb8-4b5a-addd-26ea164e036e2024-09-25WarningsExact identifier
application number: M017
anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger Company067e718a-ec0b-4895-8f9f-82d64ab4c7b42024-09-24WarningsExact identifier
application number: M017
topcare anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATETopco Associates LLCe0fb332a-2903-41ef-b35b-7cd3a74cff992024-09-24WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI83cd9f60-a4c4-4dea-97a7-cd96aade9e882024-09-24WarningsExact identifier
application number: M017
good sense itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEL. Perrigo Company162fe0a3-3995-4e6f-94ed-f839b2b0c80e2024-09-24WarningsExact identifier
application number: M017
Caring Mill Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare22ca137a-576c-a13c-e063-6394a90ae7fc2024-09-23WarningsExact identifier
application number: M017
Signature Care Anti ItchHYDROCORTISONESafewayed0eb068-3ce6-423d-a7f8-c3456b7f60402024-09-23WarningsExact identifier
application number: M017
members mark hydrocortisoneHYDROCORTISONESam's West Inc218f0dcd-fa67-4935-8019-ecbbd53ed2f72024-09-23WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEMeijer, Inc.a07496e0-6fc2-4190-8a01-f513134ffb922024-09-23WarningsExact identifier
application number: M017
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLWhitestone Products LLC2301fed7-0fa9-450d-8b1b-006f53235be02024-09-21WarningsExact identifier
application number: M017
Tibetree Cheezheng Joint Analgesic PatchCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd65a8a63f-1864-473e-be72-7840a6a5dee72024-09-20WarningsExact identifier
application number: M017
Cold Ice Analgesic GelMENTHOLDabur India Limited22915b2f-5f76-3e38-e063-6394a90a07b42024-09-20WarningsExact identifier
application number: M017
Exchange Select HydrocortisoneHYDROCORTISONEArmy & Air Force Exchange Service1b709db3-7dc1-4756-a8a0-dddda875dc572024-09-19WarningsExact identifier
application number: M017
Theraworx PM Nighttime Maximum Strength Pain ReliefLIDOCAINE HYDROCHLORIDEAVADIM HOLDINGS, INC.bc8cb476-9a47-47b3-ad78-a6ecec9ee66f2024-09-19WarningsExact identifier
application number: M017
LidocaineLIDOCAINEStratus Pharmaceuticals Ince1a8d4a7-01f7-4bab-8d09-875c461b3b612024-09-19WarningsExact identifier
application number: M017
Camphor SpiritCAMPHOR 10%Strategic Sourcing Services, LLC2216d799-7f6f-cab7-e063-6294a90a8d6c2024-09-14WarningsExact identifier
application number: M017
Meijer Analgesic Lidocaine Topical AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Incf5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa2024-09-12WarningsExact identifier
application number: M017
leader anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECardinal Health 110, LLC. dba Leadere1aab35b-80d9-4515-afb7-8c662bc5d0282024-09-11WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.849c3601-2bc8-0991-e053-2a91aa0a5e7f2024-09-03WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief Gel Platinum - ArthritisMENTHOL 8%Telebrands Corpc22cf1a5-0d5d-5ea5-e053-2995a90a333b2024-09-02WarningsExact 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