FDA.reportPublic FDA data

SATOHAP COOL and HOT

Product NDC
49873-622
11-digit product format
498730622
Labeler code
49873
Product ID
49873-622_232a4c76-1a0d-2f4b-e063-6394a90a8849
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
CAMPHOR (SYNTHETIC); CAPSAICIN; LEVOMENTHOL
Active strength
3.1; .025; 6 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SATOHAP COOL and HOT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)3.1 g/100g
CAPSAICIN.025 g/100g
LEVOMENTHOL6 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, S07O44R1ZM, BZ1R15MTK7
Rxcui2694729

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-622-01SATOHAP COOL and HOT5 in 1 POUCHPATCH51
49873-622-01SATOHAP COOL and HOT1 in 1 BOXPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-622SATOHAP COOL AND HOT (CAMPHOR, CAPSAICIN, MENTHOL) PATCH [SATO PHARMACEUTICALS CO., LTD.]1Current NDC, 2 package rows20241009_232a4c76-1a0c-2f4b-e063-6394a90a8849.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2694729camphor 3.1 % / capsaicin 0.025 % / menthol 6 % Medicated PatchPSN232a4c76-1a0c-2f4b-e063-6394a90a88491
2694729camphor 0.031 MG/MG / capsaicin 0.00025 MG/MG / menthol 0.06 MG/MG Medicated PatchSCD232a4c76-1a0c-2f4b-e063-6394a90a88491
2694729camphor 3.1 % / capsaicin 0.025 % / menthol 6 % Medicated PatchSY232a4c76-1a0c-2f4b-e063-6394a90a88491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49873-622-01498730622011 POUCH in 1 BOX (49873-622-01) / 5 PATCH in 1 POUCH / 6.3 g in 1 PATCH1 pouch2024-09-01NoNoHistorical