FDA.reportPublic FDA data

Arex Sinsin Pas

Product NDC
55264-021
Requested package NDC
55264-021-06
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 60 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFVALU MERCHANDISERS, CO3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff2025-11-24WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDERVALU MERCHANDISERS, CO89a5c4bb-442f-d3f0-e053-2a95a90a51bd2025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d11ab8e-d3ea-c7ef-e063-6294a90ae0a32025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d113dec-8832-d984-e063-6394a90ae7b32025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d12f03f-dd8b-0be5-e063-6294a90a43db2025-11-24WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d129641-eaea-c3ee-e063-6394a90aa58f2025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d1059cc-1b0b-4e7b-e063-6294a90a56ea2025-11-24WarningsExact identifier
application number: M017
GuruNanda Pain ReliefMENTHOL AND CAMPHORGURUNANDA, LLC3ca78342-cc6d-5f6b-e063-6294a90a3f1c2025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d118256-90ee-28ef-e063-6394a90a21e82025-11-24WarningsExact identifier
application number: M017
health beyondHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af2025-11-23WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 3 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4429fea8-46f8-8f7f-e063-6394a90a34b42025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 2 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442a926b-d7c1-4e35-e063-6394a90ad9482025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 1 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442aae32-4ac6-5dd6-e063-6294a90aad022025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 1-3 Step21MG NICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442ae0fa-a1ed-7901-e063-6294a90ab7172025-11-22WarningsExact identifier
application number: M017
IceQuake Lidocaine AnalgesicLIDOCAINE HYDROCHLORIDEDextrum Laboratories, Inc441daa6f-f273-ac09-e063-6394a90a252c2025-11-21WarningsExact identifier
application number: M017
Nighttime 4X Medicated CreamBENZOCAINERite Aid21645ed1-2dc0-223a-e063-6394a90ab0212025-11-21WarningsExact identifier
application number: M017
4x Medicated Gum CreamBENZOCAINEAlbertsonsb81a308c-9c30-0e3d-e053-2a95a90a15d22025-11-21WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCb0edd9d9-951f-d3dd-e053-2995a90a8d5a2025-11-21WarningsExact identifier
application number: M017
Up upLIDOCAINE PAIN RELIEF MAXIMUM STRENGTH PATCHESTarget Corporation44121d40-86e1-0df6-e063-6294a90aedaf2025-11-20WarningsExact 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