Home NDC 55264-116 Sinsinpas Arex Flex Gel Pain Relieving Patch
Product NDC 55264-116
11-digit product format 552640116
Labeler code 55264
Product ID 55264-116_409989d2-3458-6fab-e063-6294a90a57ab
Type HUMAN OTC DRUG
Nonproprietary name L-Menthol
Dosage form PATCH
Route TOPICAL
Labeler Sinsin Pharmaceutical Co., Ltd.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-01
Substance METHYL SALICYLATE; CAMPHOR (SYNTHETIC); LEVOMENTHOL
Active strength 57.6; 96; 76.8 mg/1; mg/1; mg/1
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 Sinsinpas Arex Flex Gel Pain Relieving Patch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 57.6 mg/1 CAMPHOR (SYNTHETIC) 96 mg/1 LEVOMENTHOL 76.8 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LAV5U5022Y Internal UNII lookup 5TJD82A1ET Internal UNII lookup BZ1R15MTK7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2568113 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55264-116-01 Sinsinpas Arex Flex Gel Pain Relieving Patch 6 in 1 PATCH PATCH 6 2 55264-116-02 Sinsinpas Arex Flex Gel Pain Relieving Patch 1 in 1 POUCH PATCH 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55264-116 SINSINPAS AREX FLEX GEL PAIN RELIEVING PATCH (L-MENTHOL) PATCH [SINSIN PHARMACEUTICAL CO., LTD.] 1 Current NDC, 2 package rows 20240503_1758ef9b-4fac-4066-e063-6394a90a8cc3.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 78 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55264-116-01 55264011601 6 in 1 PATCH Historical 55264-116-02 55264011602 1 PATCH in 1 POUCH (55264-116-02) / 6 PATCH in 1 PATCH (55264-116-01) 1 patch 2024-05-01 No No Current