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 |
|---|---|---|---|---|---|---|
| Red hot | CAPSAICIN | The Hygenic Company, LLC | d100092c-e10b-2063-e053-2995a90aedb2 | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL | Troy Manufacturing, Inc. | c8d4ae28-efc4-6a00-e053-2a95a90a40bf | 2023-10-25 | Warnings | M017 |
| Cryo10 Topical Analgesic | MENTHOL | Element 26 LLC | ff1d2140-9302-918c-e053-6394a90acb9a | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL | Troy Manufacturing, Inc. | 3336cc35-e773-4705-84b5-61040604beef | 2023-10-25 | Warnings | M017 |
| CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant | BENZOCAINE, WHITE PETROLATUM | Carma Laboratories, Inc. | bbf0abcd-b7d6-b5e4-e053-2995a90a5240 | 2023-10-25 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | bbee66b9-39ff-4e7e-e053-2995a90a43be | 2023-10-25 | Warnings | M017 |
| XtraCare Ice Cold Topical Analgesic Gel | MENTHOL | Rejoice International | d38f3099-d940-44d8-aa7f-404157c5e0e3 | 2023-10-24 | Warnings | M017 |
| Family Wellness | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fefbe351-1cd9-4a2f-a43d-51e2c4eb180b | 2023-10-24 | Warnings | M017 |
| TheraPlus Plus | MENTHOL | Zhejiang Jingwei Pharmaceutical Co., Ltd. | d4119f84-eb60-4134-b58e-de13d9601199 | 2023-10-24 | Warnings | M017 |
| Family Wellness | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | cddc9c4a-7c58-4225-921a-05d6afb49178 | 2023-10-24 | Warnings | M017 |
| Theraworx Pain Relief Roll- On- Lidocaine | LIDOCAINE HYDROCHLORIDE | AVADIM HOLDINGS, INC. | b4ce3876-f9e3-43ca-810b-75fbe6f887b6 | 2023-10-23 | Warnings | M017 |
| NUMOTIZINE | MENTHOL | Hobart Laboratories, Inc. | 9a29ad1b-4ba3-403f-90c9-ee7582fe4535 | 2023-10-20 | Warnings | M017 |
| Numfast Tetracaine Green | TETRACAINE | Unit Dose, Ltd. | 77d9e6ea-1cd3-4447-ba74-01cd7143e27c | 2023-10-19 | Warnings | M017 |
| Liprotek | PETROLATUM, LIDOCAINE | Unit Dose, Ltd. | 051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa5 | 2023-10-19 | Warnings | M017 |
| GENUINE FIRST AID Antiseptic Pain Relieving | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | bc7c6739-6068-4694-adc9-0c0c5c347df4 | 2023-10-19 | Warnings | M017 |
| CVS Itch relief moisturizing | PRAMOXINE HCL 1% | CVS Health | f3a753fc-f448-6bba-e053-2a95a90a8e1b | 2023-10-18 | Warnings | M017 |
| Zylotrol | LIDOCAINE HCL 4%, MENTHOL 1% | Asclemed USA, Inc. | e13984ea-73a9-2894-e053-2995a90a8ed6 | 2023-10-16 | Warnings | M017 |
| EXOTEN-C | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Asclemed USA, Inc. | 76ed37e0-64b5-4abe-a03c-3dc7084a3919 | 2023-10-16 | Warnings | M017 |
| Calypxo Pain Relief | METHYL SALICYLATE, MENTHOL | Asclemed USA, Inc | bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6 | 2023-10-16 | Warnings | M017 |
| Calypxo HP Pain Relief | METHYL SALICYLATE, MENTHOL | Asclemed USA, Inc | 89a8c267-bd92-4d0d-8e50-c52224aff9cd | 2023-10-16 | 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 |