Home NDC 55264-012 SINSINPAP COOL
Product NDC 55264-012
11-digit product format 552640012
Labeler code 55264
Product ID 55264-012_2b28bf4c-b04c-b74a-e063-6394a90ac81c
Type HUMAN OTC DRUG
Nonproprietary name LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS
Dosage form PATCH
Route CUTANEOUS; TOPICAL; TRANSDERMAL
Labeler Sinsin Pharmaceutical Co., Ltd.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-05-30
Substance LEVOMENTHOL; THYMOL; CAMPHOR (SYNTHETIC); PEPPERMINT OIL; EUCALYPTUS OIL
Active strength 49.4; 16.5; 82.4; 164.7; 16.5 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 55264-012-05 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 55264-012-05 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 55264-012-05 bd6a592717d7…303034d00443…
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 SINSINPAP COOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOMENTHOL 49.4 mg/1 THYMOL 16.5 mg/1 CAMPHOR (SYNTHETIC) 82.4 mg/1 PEPPERMINT OIL 164.7 mg/1 EUCALYPTUS OIL 16.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1795944 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55264-012-04 SINSINPAP COOL 5 in 1 POUCH PATCH 5 5 55264-012-05 SINSINPAP COOL 1 in 1 CARTON PATCH 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55264-012 SINSINPAP COOL (LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS) PATCH [SINSIN PHARMACEUTICAL CO., LTD.] 5 Current NDC, Legacy NDC, 2 package rows 20250109_9d47855f-ccb5-4557-a31a-a2b336fa9806.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 77 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 Marketing end Sample Exclude flag Status 55264-012-04 55264001204 5 in 1 POUCH Historical 55264-012-05 55264001205 1 POUCH in 1 CARTON (55264-012-05) / 5 PATCH in 1 POUCH (55264-012-04) 1 pouch 2016-05-30 0000-00-00 No No Current