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 |
|---|---|
| CAMPHOR (SYNTHETIC) | 34.1 mg/1 |
| PEPPERMINT OIL | 45.46 mg/1 |
| LEVOMENTHOL | 90.9 mg/1 |
| METHYL SALICYLATE | 90.9 mg/1 |
| ZINC OXIDE | 431.82 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5TJD82A1ET | Internal UNII lookup |
| AV092KU4JH | Internal UNII lookup |
| BZ1R15MTK7 | Internal UNII lookup |
| LAV5U5022Y | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a851854a-5dfe-4bd5-95f6-67c3f13f1187 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-02-24 | Arex Sinsin Pas Large |
| 2023-02-24 | Arex Sinsin Pas Large |
| 2023-01-30 | Arex Sinsin Pas Large |
| 2023-01-30 | Arex Sinsin Pas Large |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55264-021-06 | Arex Sinsin Pas | 1 in 1 CARTON | PATCH | 1 | 11 | |
| 55264-021-06 | Arex Sinsin Pas | 6 in 1 POUCH | PATCH | 6 | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55264-021 | AREX SINSIN PAS (CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250109_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pain Relieving Cooling | MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | 3574d48a-b546-4ea7-b470-071bb328de64 | 2024-02-08 | Warnings | M017 |
| Advil Targeted Relief | CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE | Haleon US Holdings LLC | 16e6be21-7b43-443a-89ec-3bdf0ec0dfc1 | 2024-02-08 | Warnings | M017 |
| POINT RELIEF COLD SPOT Pain Relieving | MENTHOL | FABRICATION ENTERPRISES | 96f1d592-6cec-412e-a5fd-cf3c4f68644f | 2024-02-07 | Warnings | M017 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Safetec of America, Inc. | 1c5eb3b3-79b3-472a-ae36-ec6a7dc72925 | 2024-02-07 | Warnings | M017 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Safetec of America, Inc. | 8eb3e7e2-26e5-430e-89aa-40a0367c637e | 2024-02-07 | Warnings | M017 |
| Nova Natura Topical Analgesic | CAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATE | SEYITLER KIMYA SANAYI ANONIM SIRKETI | abf00f73-f0b1-439e-85aa-bbce8a1ec920 | 2024-02-06 | Warnings | M017 |
| Leader Burn Relief | LIDOCAINE | Cardinal Health | f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 | 2024-02-06 | Warnings | M017 |
| Pain Relieving Petro Carbo | PHENOL | J.R. Watkins, LLC. | 050cf17d-3be7-45b9-8524-ad82af309a0e | 2024-02-06 | Warnings | M017 |
| White Cream | CAMPHOR (NATURAL) AND TURPENTINE OIL | J.R. Watkins, LLC. | e4de0734-59d5-478c-86ea-66fc2ba003e7 | 2024-02-05 | Warnings | M017 |
| Pain Relieving Roll-On | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | 80118260-9c88-402d-9a90-ecfe62b4b54f | 2024-02-05 | Warnings | M017 |
| Pain Relieving | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | df512ce6-ce1b-434d-9571-fb2e1d76e1d0 | 2024-02-05 | Warnings | M017 |
| Pain Relieving | MENTHOL | Safetec of America, Inc. | 52ebf64d-095f-467e-bf51-dd8d33b58c7d | 2024-02-05 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Safetec of America, Inc. | 4f4c801b-d894-4fa3-b024-6ca41a5f2a95 | 2024-02-04 | Warnings | M017 |
| Analgesic | MENTHOL | Safetec of America, Inc. | 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802 | 2024-02-04 | Warnings | M017 |
| HAV EZ Penetrating Pain Relief | MENTHOL | PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC | 70006efc-9cc8-4490-b28c-fcb23b1737c4 | 2024-02-01 | Warnings | M017 |
| Rugby Capsaicin External Analgesic | CAPSAICIN | Proficient Rx LP | 7c733a30-5002-49e7-a6bd-7737a1d2461e | 2024-02-01 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Proficient Rx LP | ccb62898-b614-45b9-95ea-23e5e31893a8 | 2024-02-01 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE | Proficient Rx LP | 0b26d92f-9d0e-46d4-a8bc-75d6da5f6199 | 2024-02-01 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Proficient Rx LP | c57d5f8e-5934-4cbb-999a-cdd55e5b105f | 2024-02-01 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Proficient Rx LP | 47e9fe84-bd0c-40ea-85de-e950bcacc557 | 2024-02-01 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55264-021-06 | 55264002106 | 1 POUCH in 1 CARTON (55264-021-06) / 6 PATCH in 1 POUCH | 1 pouch | 2018-11-09 | 0000-00-00 | No | No | Current |