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 |
|---|---|---|---|---|---|---|
| COOL BREEZE Pain Relief | MENTHOL | COOL BREEZE US LLC | 14dcf4ee-6778-49d4-8601-9205737432ea | 2023-11-01 | Warnings | M017 |
| Lidozen | LIDOCAINE HYDROCHLORIDE, MENTHOL | Proficient Rx LP | 1ebb45e5-4541-4c95-abe1-661ef763a610 | 2023-11-01 | Warnings | M017 |
| Walgreens Pain Relieving Cream | LIDOCAINE 4% | Walgreens | ce1b55ed-f5c5-ea8b-e053-2a95a90acd40 | 2023-10-31 | Warnings | M017 |
| Walgreens pain relieving | LIDOCAINE 4% | Walgreens | ce2b9e57-749d-715c-e053-2995a90aaf8d | 2023-10-31 | Warnings | M017 |
| Walgreens Cool n heat | LIDOCAINE 4% MENTHOL 1% | Walgreens | ce168ab7-ec4a-daea-e053-2995a90af829 | 2023-10-31 | Warnings | M017 |
| Methyl Salicylate 40 Percent | METHYL SALICYLATE | Alexso, Inc | 53407aab-094c-4393-a2b9-54fd85321e3e | 2023-10-31 | Warnings | M017 |
| Hydrocortisone Acetate | HYDROCORTISONE ACETATE | Bentlin Products LLC | 4346351c-8e11-46ae-b428-98d17f55beb9 | 2023-10-30 | Warnings | M017 |
| Biofreeze Roll-On | MENTHOL | A-S Medication Solutions | 814b37ea-5441-4cec-8794-71ca01d849ae | 2023-10-30 | Warnings | M017 |
| Dr. Sheffield Hydrocortisone Anti itch | HYDROCORTISONE | Sheffield Pharmaceuticals LLC | 71c9f2f4-2188-45eb-b55e-3856ac78070b | 2023-10-30 | Warnings | M017 |
| Family Wellness | BENZOCAINE, RESORCINOL | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. | df540eb8-6773-4647-9cc2-c3fd14d7355e | 2023-10-27 | Warnings | M017 |
| Family Wellness | HYDROCORTISONE 1% | FRONT PHARMACEUTICAL PLC | ea26265d-f24e-458e-8bf0-287b2d49f4f4 | 2023-10-27 | Warnings | M017 |
| Joint Formula 88 MAX PLUS | CAMPHOR | Sarati International, Inc. | f5d78335-b78d-4909-a88b-9daa3c18ba15 | 2023-10-27 | Warnings | M017 |
| OsmoFlex | MENTHOL | Sarati International, Inc. | 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e | 2023-10-27 | Warnings | M017 |
| Thera plus Anti-itch with aloe Hydrocortisone | HYDROCORTISONE | Fourstar Group USA, Inc. | c69d0670-a65b-1680-e053-2995a90a2ee5 | 2023-10-26 | Warnings | M017 |
| Family Wellness | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | FRONT PHARMACEUTICAL PLC | fde2069b-344e-46da-bb95-c5113e0f35d6 | 2023-10-26 | Warnings | M017 |
| MAXIMUM STRENGTH HEMORRHOIDAL RELIEF | LIDOCAINE | CVS PHARMACY, INC | b61424bf-3b23-420b-a7bc-256ddb96aa22 | 2023-10-25 | Warnings | M017 |
| Assured | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. | bc97f364-9443-47b8-9c2d-b5dcc00cc9b7 | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL, UNSPECIFIED FORM | Troy Manufacturing, Inc. | b41091b4-0dc0-4a88-8ff6-11979b3d307a | 2023-10-25 | Warnings | M017 |
| Thera Plus | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | bcc99e5a-2403-46da-9c9d-8411fa4104e0 | 2023-10-25 | Warnings | M017 |
| Assured | LIDOCAINE HYDROCHLORIDE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c | 2023-10-25 | 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 |