FDA.reportPublic FDA data

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 70 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RELISPRAY NATURAL PAIN RELIEFMENTHOLMidas-Care Pharmaceuticals, Pvt. Ltdadc8a43c-19a1-4eb3-9820-b63f7b5e91ea2025-10-30WarningsExact identifier
application number: M017
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
application number: M017
zourunan Relieve itching cream ANTIFUNGALRELIEVE ITCHING CREAMGuchutang Biotechnology (Longyan) Co., Ltd41bb9ced-dde4-2998-e063-6394a90a81592025-10-29WarningsExact identifier
application number: M017
zourunan Intensive healing lotion. for ECZEMAINTENSIVE HEALING LOTIONGuchutang Biotechnology (Longyan) Co., Ltd41bad9f3-f1a7-e92c-e063-6394a90ad0ba2025-10-29WarningsExact identifier
application number: M017
Aromalief Pain Relief Cream Orange GingerMENTHOLMarketites LLC9e8d3611-ef1b-4ac6-e053-2995a90af28a2025-10-29WarningsExact identifier
application number: M017
Aromalief Calming Pain Relief Cream LavenderMENTHOLMarketites LLCb8197d52-ccfb-b008-e053-2995a90a0a532025-10-29WarningsExact identifier
application number: M017
Aromalief Cozy Vanilla Pain Relief CreamMENTHOLMarketites LLC3634e55e-8c62-a782-e063-6394a90a65082025-10-29WarningsExact identifier
application number: M017
BENOVA PAIN AND ITCH RELIEFMENTHOL, 0.11%BENOVA RX LLC42513ee2-8b40-a9f3-e063-6394a90a93862025-10-29WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINECVS Pharmacy7e9285fd-26d5-3eac-e053-2991aa0ae2db2025-10-29WarningsExact identifier
application number: M017
Coralite Ultra Strength Pain ReliefCAMPHOR MENTHOLUnited Exchange Corp.44ecf959-cc07-4adc-a500-075b2ee695482025-10-29WarningsExact identifier
application number: M017
GoodSense Pain ReliefLIDOCAINEGeiss, Destin & Dunn, Inc826f8da4-8468-ea0a-e053-2991aa0a66cb2025-10-28WarningsExact identifier
application number: M017
CALMADOLCAMPHOR, MENTHOL, METHYL SALICYLATEGRANDALL DISTRIBUTING, LLC31b7f84e-8b66-4d31-8e9c-279d0af2fe642025-10-28WarningsExact identifier
application number: M017
XRay DOLCAMPHOR, MENTHOL, AND METHYL SALICYLATEGenomma Lab USA, Inc.e07fef46-68d9-769c-e053-2a95a90aa0652025-10-28WarningsExact identifier
application number: M017
CVS Medicated HeatCAPSICUM EXTRACTCVS Pharmacy81cd1019-93a6-311b-e053-2991aa0a79972025-10-28WarningsExact identifier
application number: M017
Foster and ThriveLIDOCAINESTRATEGIC SOURCING SERVICES, LLCf950b072-d978-b629-e053-6394a90abfaf2025-10-28WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
application number: M017
PRMENTHOLAmphp, Inc6f5b9e08-c445-4fac-e053-2a91aa0aa7372025-10-27WarningsExact identifier
application number: M017
LidocaineBURN RELIEFFoodhold USAb25dc0df-02d0-41ac-b36c-2c04baa77ef22025-10-27WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREEFSA Store Inc.fb3548c8-f202-dc50-e053-6394a90a5b302025-10-27WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CONTINUOUS SPRAYPremier Brands of America, Inc.d344f68b-9b62-3029-e053-2995a90a16652025-10-27WarningsExact 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