FDA.reportPublic FDA data

Sinsinpas arex patch large

Product NDC
55264-024
11-digit product format
552640024
Labeler code
55264
Product ID
55264-024_5a2463cd-c6dc-9749-e063-6294a90ae5da
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL; TRANSDERMAL
Labeler
Sinsin Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-06
Substance
METHYL SALICYLATE; LEVOMENTHOL; CAMPHOR (SYNTHETIC)
Active strength
90.9; 90.9; 34.1 mg/1; mg/1; mg/1
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
Sinsinpas arex patch large
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE90.9 mg/1
LEVOMENTHOL90.9 mg/1
CAMPHOR (SYNTHETIC)34.1 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
BZ1R15MTK7Internal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47c242da-56cd-bea1-e063-6394a90a41deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-024-06Sinsinpas arex patch large6 in 1 POUCHPATCH63
55264-024-06Sinsinpas arex patch large1 in 1 CARTONPATCH13

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 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IceQuake Analgestic WhiteMETHYL SALICYLATE, MENTHOLSouthern Sales & Service, Inc.54e5dcd5-9987-488d-a758-d0e76d1551822023-11-29WarningsExact identifier
application number: M017
Icequake Coldn Hot medicated patchMENTHOLSouthern Sales & Service, Inc.89202c52-9eb7-4e5a-a709-4a66ab0d3a722023-11-29WarningsExact identifier
application number: M017
IceQuake Lidocaine AnalgesicLIDOCAINE HYDROCHLORIDESouthern Sales & Service, Inc.9089cb78-e9f8-4437-a767-df809a114c4b2023-11-29WarningsExact identifier
application number: M017
Ice Quake Muscle Rub BlueMENTHOLSouthern Sales & Service, Inc.5180f6a3-58f1-4c50-a33b-7d85a3c1b99b2023-11-29WarningsExact identifier
application number: M017
Discount Drug Mart Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEDiscount Drug Mart8579df23-ac07-9df8-e053-2991aa0a8bbb2023-11-29WarningsExact identifier
application number: M017
SatohapMETHYL SALICYLATE, DL-CAMPHOR, L-MENTHOLSato Pharmaceutical Co., Ltd.3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf2023-11-28WarningsExact identifier
application number: M017
Poli-AHYDROCORTISONE ACETATESato Pharmaceutical Co., Ltd.e27a3840-d9de-4bd0-ad75-8a151bd12b832023-11-28WarningsExact identifier
application number: M017
Sheffield Arthritis and Muscle Pain ReliefCAPSICUM OLEORESINSheffield Pharmaceuticals LLC724b9870-e86a-4087-ba78-8c944ce3baa62023-11-28WarningsExact identifier
application number: M017
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMSheffield Pharmaceuticals LLC60d1d826-a53e-42e5-bc30-1b2c2690445b2023-11-28WarningsExact identifier
application number: M017
Thera Plus Cold Therapy Pain Relieving MentholMENTHOLFourstar Group USA, Inc.0a462c91-5300-e282-e063-6394a90a4cc22023-11-27WarningsExact identifier
application number: M017
UtaSprayMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLCc641ab11-cd00-4e23-ace7-8178739084f02023-11-21WarningsExact identifier
application number: M017
Top Medicated OilCAMPHOR, MENTHOL, METHYL SALICYLATEBig 5 Nutrition LLCb2f0d1e1-7d03-434e-be39-9f980459690c2023-11-21WarningsExact identifier
application number: M017
BT Pain Relief BalmMETHYL SALICYLATE, MENTHOL, CAMPHORBig 5 Nutrition LLC50112419-c934-4d3a-9ea6-9b089f516a6d2023-11-21WarningsExact identifier
application number: M017
BT Pain ReliefMENTHOL, METHYL SALICYLATEBig 5 Nutrition LLC91324910-27cf-424f-9e9b-6173f2d7acbf2023-11-21WarningsExact identifier
application number: M017
Dit Da ShuiMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLC5d45cb48-3e88-4d58-81d2-6f88d7a821342023-11-20WarningsExact identifier
application number: M017
Herbal BalmMETHYL SALICYLATE, MENTHOL ANDBig 5 Nutrition LLC09b3b86d-3434-428b-b0a8-e8dfd7c0b52a2023-11-20WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesb505769e-9c46-3cf3-e053-2a95a90a4df92023-11-17WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesd6523993-d781-cdbc-e053-2a95a90af1912023-11-17WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.4d91baf3-9655-4786-93b8-aa0d93fe0bf92023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPMENTHOLKOBAYASHI Healthcare International, Inc.7ef03298-6623-4cf4-b21f-74b2ffc11c6e2023-11-16WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55264-024-06552640024061 POUCH in 1 CARTON (55264-024-06) / 6 PATCH in 1 POUCH1 pouch2026-01-06NoNoCurrent