FDA.reportPublic FDA data

Arex Sinsin Pas

Product NDC
55264-021
11-digit product format
552640021
Labeler code
55264
Product ID
55264-021_40970333-ce53-7b17-e063-6294a90abb59
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Mentha Oil, Menthol, Methyl Salicylate, Zinc Oxide
Dosage form
PATCH
Route
CUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Sinsin Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-26
Substance
CAMPHOR (SYNTHETIC); PEPPERMINT OIL; LEVOMENTHOL; METHYL SALICYLATE; ZINC OXIDE
Active strength
34.1; 45.46; 90.9; 90.9; 431.82 mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
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
Arex Sinsin Pas
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)34.1 mg/1
PEPPERMINT OIL45.46 mg/1
LEVOMENTHOL90.9 mg/1
METHYL SALICYLATE90.9 mg/1
ZINC OXIDE431.82 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
AV092KU4JHInternal UNII lookup
BZ1R15MTK7Internal UNII lookup
LAV5U5022YInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a851854a-5dfe-4bd5-95f6-67c3f13f1187Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-24Arex Sinsin Pas Large
2023-02-24Arex Sinsin Pas Large
2023-01-30Arex Sinsin Pas Large
2023-01-30Arex Sinsin Pas Large

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-021-06Arex Sinsin Pas1 in 1 CARTONPATCH111
55264-021-06Arex Sinsin Pas6 in 1 POUCHPATCH611

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
LEVOMENTHOLACTIVE INGREDIENTBZ1R15MTK7AREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
PEPPERMINT OILACTIVE INGREDIENTAV092KU4JHAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
LEVOMENTHOLACTIVE MOIETYBZ1R15MTK7AREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
PEPPERMINTACTIVE MOIETYV95R5KMY2BAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
BENZYL NICOTINAMIDEINACTIVE INGREDIENTHF1W0213QPAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
NATURAL LATEX RUBBERINACTIVE INGREDIENT2LQ0UUW8INAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
NONIVAMIDEINACTIVE INGREDIENTS846B891ORAREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7AREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
POLYISOBUTYLENE (200000 MW)INACTIVE INGREDIENTZ6Y02I0591AREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2
ROSININACTIVE INGREDIENT88S87KL877AREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-021AREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]10Current NDC, Legacy NDC, 2 package rows20250109_a851854a-5dfe-4bd5-95f6-67c3f13f1187.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 149 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bakers Best Maximum Strength Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLBaker's Best Health Products, LLC9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d2023-11-06WarningsExact identifier
application number: M017
BAKERS BEST Pain Relief with Pure Hemp Seed OilLIDOCAINE HYDROCHLORIDE, MENTHOLBAKER'S BEST HEALTH PRODUCTS, INC.ae54c234-bfe4-4a74-b293-db7efda7884b2023-11-06WarningsExact identifier
application number: M017
Arth RX Topical AnalgesicMETHYL NICOTINATE, CAPSAICINHCD Salesa7b3b9b4-b1c4-4e51-8e3a-c84f64c756092023-11-06WarningsExact identifier
application number: M017
BAKERS BEST Arthritis Pain Relief Cream with Hemp and LavenderHISTAMINE DIHYDROCHLORIDEBAKER'S BEST HEALTH PRODUCTS, INC.03ec87c5-6669-4afb-8d9c-c8dc9907495d2023-11-06WarningsExact identifier
application number: M017
DOCTORS TOUCH Erase The PainMENTHOLDOCTOR'S CHOICE MEDICAL, LLCfe9ce2c7-d6af-4dad-b6e6-5049a9e091b02023-11-06WarningsExact identifier
application number: M017
RadiaGuard Advanced Radiation ReliefLIDOCAINE HYDROCHLORIDESMOOTH SIDE, INC21205087-5a2e-41a5-be40-30cba28954082023-11-06WarningsExact identifier
application number: M017
BLUE SPRING Foot and Leg ComfortMENTHOLACA MANAGEMENT LLC5f52218d-eea4-4640-b820-84c077ab98ba2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Red Hot Pepper Pain Relief CreamMENTHOL, CAPSAICINACA MANAGEMENT LLC36293885-b2dd-4fba-9748-35a3c9e050782023-11-06WarningsExact identifier
application number: M017
ROPANA Pain Relief CreamHISTAMINE DIHYDROCHLORIDEFUSION PAIN SOLUTIONS LLCe0342aa3-ca80-40b7-bec6-1b33c4db398b2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Cool Menthol Therapy Pain Relief CreamMENTHOLACA MANAGEMENT LLC16894346-3513-41b1-b09f-72d84edcc4ac2023-11-06WarningsExact identifier
application number: M017
SKINS DELAY Climax Control LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED0db91010-12f7-4f20-b96c-432915720d5a2023-11-06WarningsExact identifier
application number: M017
POWERECT Lidocaine Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED42e0c40f-1efd-45ef-815d-53d193d720eb2023-11-06WarningsExact identifier
application number: M017
ARTHRO LIFE Instant Pain Relief CreamMENTHOLBIOBEST SERVICES LLC66eb1a78-6861-4693-b68e-bd4a664fc0752023-11-06WarningsExact identifier
application number: M017
PARACTIN QuantumActiv Pain Relief CreamMENTHOLNHR SCIENCE CORPae2f89cf-120c-4c6f-9e81-4560e6fa03732023-11-06WarningsExact identifier
application number: M017
FISICO Arthrozene Pain CreamMENTHOLFISICO INC.d02c4349-78dd-4672-9582-50124ea9f1e12023-11-06WarningsExact identifier
application number: M017
BRONSON SOOTHE Pain ReliefCAPSAICINBRONSON NUTRITIONALS, LLCcedf8f43-b9a3-4a06-b3a1-cf82668541f82023-11-06WarningsExact identifier
application number: M017
INTIMALE Benzocaine Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITEDb845bfd5-ab73-495f-97ef-e959bc6311d92023-11-06WarningsExact identifier
application number: M017
RAPID PAIN-RELIEF TOPICALLIDOCAINE HYDROCHLORIDE, MENTHOLNORDIC HEALTHY LIVING INC.a06d6aca-9aa2-4bbe-bf77-4c85f1dd78702023-11-06WarningsExact identifier
application number: M017
PURE PERSONAL All Natural Pain Relief CreamMENTHOLPURE PERSONAL CARE, LLC8f3fb1d0-d238-4b4c-9816-7e335258d71d2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLC89c80a8f-227d-4ec0-9327-683892e73b6a2023-11-06WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55264-021-06552640021061 POUCH in 1 CARTON (55264-021-06) / 6 PATCH in 1 POUCH1 pouch2018-11-090000-00-00NoNoCurrent