Sinsinpas Arex Flex Gel Pain Relieving Patch

Product NDC
55264-116
11-digit product format
552640116
Labeler code
55264
Product ID
55264-116_409989d2-3458-6fab-e063-6294a90a57ab
Type
HUMAN OTC DRUG
Nonproprietary name
L-Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Sinsin Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-01
Substance
METHYL SALICYLATE; CAMPHOR (SYNTHETIC); LEVOMENTHOL
Active strength
57.6; 96; 76.8 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Sinsinpas Arex Flex Gel Pain Relieving Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE57.6 mg/1
CAMPHOR (SYNTHETIC)96 mg/1
LEVOMENTHOL76.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
5TJD82A1ETInternal UNII lookup
BZ1R15MTK7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2568113Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1758ef9b-4fac-4066-e063-6394a90a8cc3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-116-01Sinsinpas Arex Flex Gel Pain Relieving Patch6 in 1 PATCHPATCH62
55264-116-02Sinsinpas Arex Flex Gel Pain Relieving Patch1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-116SINSINPAS AREX FLEX GEL PAIN RELIEVING PATCH (L-MENTHOL) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]1Current NDC, 2 package rows20240503_1758ef9b-4fac-4066-e063-6394a90a8cc3.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 144 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr PAINES Pain ReliefMENTHOLDOCTOR PAINE'S MEDICAL, LLC79d2b332-051e-48c1-afe8-6d4468cd18782023-11-11WarningsExact identifier
application number: M017
INTIMALE Maximum Strength DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED25b9ade3-72b0-4b86-8c48-90310a26806f2023-11-11WarningsExact identifier
application number: M017
POWERECT Max Power Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED25a1c926-9543-44a7-865e-a4b6e1a40cbe2023-11-11WarningsExact identifier
application number: M017
SKINS DELAY Maximum Strength LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED172efe5d-28b8-443c-b3f9-4296691890812023-11-11WarningsExact identifier
application number: M017
GASPARI Ageless Pain Relief CreamMENTHOLGASPARI ANTI-AGING LLCea806089-688b-4944-ad69-86f366509eb52023-11-11WarningsExact identifier
application number: M017
ZENSEZONE Arthmed Temporary Pain Relief CreamCAPSAICIN, MENTHOL, METHYL SALICYLATEZENSEZONE LLCc5778f22-c411-4bd7-b2af-45e3fee15fd22023-11-11WarningsExact identifier
application number: M017
PRFC HEMP Topical AnalgesicMENTHOLDOBEST INC722da9d1-91d7-45be-adb1-8d6a22aa83ac2023-11-11WarningsExact identifier
application number: M017
AMP RELIEF Pain Relief CreamMENTHOLCOASTAL FORMULAS LLC84ea496e-ab54-4882-93ef-600f8eb33cb42023-11-11WarningsExact identifier
application number: M017
AMP RELIEF Pain Relief CreamMENTHOLCOASTAL FORMULAS LLC39564c67-49ab-42d4-a391-792ac69180c02023-11-11WarningsExact identifier
application number: M017
LIDOSOLVE PAIN RELIEFLIDOCAINE HYDROCHLORIDEHENNIKA HEALTH, LLC3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e22023-11-11WarningsExact identifier
application number: M017
AMINO ACTIVE Topical Analgesic CreamHISTAMINE DIHYDROCHLORIDEVIREO SYSTEMS, INC.591b1e7e-a8c0-4640-a592-4e0f3538a40e2023-11-11WarningsExact identifier
application number: M017
NERVE ACTIVE Pain Relief CreamMENTHOLTOP DOG DIRECT, LLCa8b85dcb-fd3e-4340-a945-609fc741443c2023-11-11WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine BackLIDOCAINEGeri-Gentle Corporatione4427928-c063-9ca6-e053-2995a90a1aa12023-11-10WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch Arm and NeckMENTHOLGeri-Gentle Corporatione4429f70-667e-662b-e053-2a95a90a62ba2023-11-10WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch BackMENTHOLGeri-Gentle Corporatione442b8ec-a3de-65e8-e053-2995a90af3ec2023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.9f948fb4-4275-4a1f-83f8-cd708db4a2962023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF PAIN RELIEFMENTHOLBLUE SPRING WELLNESS, L.L.C.b4278b70-e9a6-4d1f-bbad-257fe437b86a2023-11-10WarningsExact identifier
application number: M017
BLUE SPRING Foot and Leg Comfort Cream with Pain ReliefMENTHOL, CAPSAICINBLUE SPRING WELLNESS, L.L.C.2f9cf514-48be-49ec-b424-0b228b4b874a2023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.1231ddd2-7661-45b2-ab15-32f7fdc078a82023-11-10WarningsExact identifier
application number: M017
SUPER WHITE Stuff Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.7779b26b-ae3b-4639-a6b0-826c7ab37a862023-11-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2568113camphor 96 MG / levomenthol 76.8 MG / methyl salicylate 57.6 MG Medicated PatchPSN1758ef9b-4fac-4066-e063-6394a90a8cc32
2568113camphor 96 MG / levomenthol 76.8 MG / methyl salicylate 57.6 MG Medicated PatchSCD1758ef9b-4fac-4066-e063-6394a90a8cc32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55264-116-01552640116016 in 1 PATCHHistorical
55264-116-02552640116021 PATCH in 1 POUCH (55264-116-02) / 6 PATCH in 1 PATCH (55264-116-01) 1 patch2024-05-01NoNoCurrent