FDA.reportPublic FDA data

Sinsinpas Arex Pain Relieving Patch, Medium

Product NDC
55264-022
11-digit product format
552640022
Labeler code
55264
Product ID
55264-022_5a244916-b21e-857b-e063-6394a90aeb48
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl Salicylate
Dosage form
PATCH
Route
CUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Sinsin Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-01
Substance
LEVOMENTHOL; METHYL SALICYLATE; CAMPHOR (SYNTHETIC)
Active strength
45.45; 45.45; 17.05 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 Pain Relieving Patch, Medium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOMENTHOL45.45 mg/1
METHYL SALICYLATE45.45 mg/1
CAMPHOR (SYNTHETIC)17.05 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2730670Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46453ef2-512b-4852-e063-6394a90a8912Available 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
55264-022-11Sinsinpas Arex Pain Relieving Patch, Medium10 in 1 POUCHPATCH103
55264-022-11Sinsinpas Arex Pain Relieving Patch, Medium1 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 25 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidoTapeLIDOCAINE 4%V2 Pharma LLCed18b4f7-6a2c-4dce-9b53-e485569093c52026-04-09WarningsExact identifier
application number: M017
TheraCare Lidocaine Pain ReliefLIDOCAINEVeridian Healthcare4f112ab2-b67a-a3e2-e063-6394a90acb602026-04-09WarningsExact identifier
application number: M017
TheraCare Pain ReliefMENTHOLVeridian Healthcare4f11aa1e-de53-a3b0-e063-6294a90a2fe42026-04-09WarningsExact identifier
application number: M017
TheraCare 2X Medicated Pain ReliefLIDOCAINE, MENTHOLVeridian Healthcare4f11fca1-1949-ab8e-e063-6394a90ac6272026-04-09WarningsExact identifier
application number: M017
TheraCare Medicated Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEVeridian Healthcare4f125062-af89-40d3-e063-6394a90a27ef2026-04-09WarningsExact identifier
application number: M017
DRMITSUI ECZEMA RELIEFHYDROCORTISONE 1% ECZEMA RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4eee7637-3a28-e0bd-e063-6294a90ae1a42026-04-08WarningsExact identifier
application number: M017
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHORSinsin Pharmaceutical Co., Ltd.47c077c2-6e34-8e7a-e063-6294a90a21b52026-04-08WarningsExact identifier
application number: M017
Yi Tiao Gen Pain PatchPAIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory4828fe70-f6f8-45e4-9c9a-a9e486dc65e52026-04-07WarningsExact identifier
application number: M017
Dermatool Nerve CareLIDOCAINE HCL, MENTHOLPapalo Group, LLC4ee40c96-9350-4c68-e063-6294a90ac8122026-04-07WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINECVS Pharmacy, Inc.42b3c341-f422-b2b4-e063-6294a90a47b22026-04-06WarningsExact identifier
application number: M017
KinetiCream Pain Relieving Topical AnalgesicMENTHOLPhoenix Bioperformance Products LLCbb4c9e73-e62d-4b8c-a16c-b90db1a8b2a72026-04-06WarningsExact identifier
application number: M017
KinetiCream Anti-Inflammatory and Pain ReliefMENTHOLPhoenix Bioperformance Products LLC39a6d26b-b5f4-45d7-a9b5-6edbf42d75002026-04-06WarningsExact identifier
application number: M017
Dr. Blue PainZaway Pain Relieving Roll-OnMENTHOLIndiana Botanic Gardens4ecc8241-5a87-2f45-e063-6294a90aa30a2026-04-06WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLCVS Pharmacy, Inc.d7f52394-5cc1-48a6-ae89-9fc63b5157582026-04-06Warnings, Adverse reactionsExact identifier
application number: M017
Pain-Relieving PatchCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4ecf4a6e-5c0f-7943-e063-6394a90a81cc2026-04-06WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCHRAPID AID VIET NAM COMPANY LIMITED4edbaa1a-6e44-4865-e063-6394a90a8cc32026-04-06WarningsExact identifier
application number: M017
Capsaicin 0.1% CreamCAPSAICIN 0.1%Puretek Corporation4e83441b-cb6a-beb0-e063-6394a90a1b542026-04-03WarningsExact identifier
application number: M017
NeroCare Capsaicin Neuropathy Relief CreamCAPSAICINGuangzhou Tata Biotechnology Co., Ltd.4e89b7eb-0d84-dc57-e063-6394a90a7dd92026-04-03WarningsExact identifier
application number: M017
TheraCare Pain Relief PatchLIDOCAINE 4%Veridian Healthcare4e91da65-8191-6261-e063-6394a90a6bd52026-04-03WarningsExact identifier
application number: M017
HealthWise Roll-OnLIDOCAINE, MENTHOLVeridian Healthcare4e9306b5-949e-f7a9-e063-6394a90ae13a2026-04-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2730670camphor 17.05 MG / levomenthol 45.45 MG / methyl salicylate 45.45 MG Medicated PatchPSN46453ef2-512b-4852-e063-6394a90a89123
2730670camphor 17.1 MG / levomenthol 45.5 MG / methyl salicylate 45.5 MG Medicated PatchSCD46453ef2-512b-4852-e063-6394a90a89123
2730670camphor 17.05 MG / levomenthol 45.45 MG / methyl salicylate 45.45 MG Medicated PatchSY46453ef2-512b-4852-e063-6394a90a89123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55264-022-11552640022111 POUCH in 1 CARTON (55264-022-11) / 10 PATCH in 1 POUCH1 pouch2025-02-01NoNoCurrent