Home NDC 49873-622 SATOHAP COOL and HOT
Product NDC 49873-622
11-digit product format 498730622
Labeler code 49873
Product ID 49873-622_57efe410-5fbf-ea8c-e063-6394a90ae3da
Type HUMAN OTC DRUG
Nonproprietary name Camphor, Capsaicin, Menthol
Dosage form PATCH
Route TOPICAL
Labeler Sato Pharmaceuticals Co., Ltd.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance CAPSAICIN; CAMPHOR (SYNTHETIC); LEVOMENTHOL
Active strength .025; 3.1; 6 g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 SATOHAP COOL and HOT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPSAICIN .025 g/100g CAMPHOR (SYNTHETIC) 3.1 g/100g LEVOMENTHOL 6 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S07O44R1ZM 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 2694729 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 49873-622-01 SATOHAP COOL and HOT 5 in 1 POUCH PATCH 5 1 49873-622-01 SATOHAP COOL and HOT 1 in 1 BOX PATCH 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49873-622 SATOHAP COOL AND HOT (CAMPHOR, CAPSAICIN, MENTHOL) PATCH [SATO PHARMACEUTICALS CO., LTD.] 1 Current NDC, 2 package rows 20241009_232a4c76-1a0c-2f4b-e063-6394a90a8849.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 18 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 49873-622-01 49873062201 1 POUCH in 1 BOX (49873-622-01) / 5 PATCH in 1 POUCH / 6.3 g in 1 PATCH 1 pouch 2024-09-01 No No Current