FDA.reportPublic FDA data

Satohap Cool and Hot Pads

Product NDC
49873-621
11-digit product format
498730621
Labeler code
49873
Product ID
49873-621_21ad4b4b-1f8b-9b58-e063-6394a90a3a61
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Capsaicin, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-18
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 Pads
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
BZ1R15MTK7Internal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2694729Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6bf1eab-4ab9-f500-e053-2995a90a8d7bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-04-14Satohap Cool & Hot Pads - 5 pads in 1 pouch - (13cm by 8cm each pad)
2023-04-14Satohap Cool & Hot Pads - 5 pads in 1 pouch - (13cm by 8cm each pad)
2023-01-30Satohap Cool & Hot Pads - 5 pads in 1 pouch - (13cm by 8cm each pad)
2023-01-30Satohap Cool & Hot Pads - 5 pads in 1 pouch - (13cm by 8cm each pad)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-621-01Satohap Cool and Hot Pads5 in 1 POUCHPATCH54
49873-621-01Satohap Cool and Hot Pads1 in 1 BOXPATCH14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-621SATOHAP COOL AND HOT PADS (CAMPHOR, CAPSAICIN, MENTHOL) PATCH [SATO PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20241022_b6bf1eab-4ab9-f500-e053-2995a90a8d7b.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 1 of 155 · 3,098 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Inknows Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.59eb9c12-9e00-0171-e063-6394a90a83422026-08-25WarningsExact identifier
application number: M017
LidomarLIDOMAROncora Pharma, LLC215bfdca-60bf-480b-b02e-902de52fe5e82026-08-25WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c7e13f-b9ea-023a-e063-6294a90a79e02026-08-24WarningsExact identifier
application number: M017
KNEE PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8b33a-7d4f-2c6e-e063-6394a90a79292026-08-24WarningsExact identifier
application number: M017
Bovonte Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5958cc29-c449-56a7-e063-6394a90a960b2026-08-24WarningsExact identifier
application number: M017
JELVOXA NECK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.59a3d60a-26b5-e6a6-e063-6294a90a42bd2026-08-22WarningsExact identifier
application number: M017
JELVOXA DMSOCAMPHOR CAPSAICIN MENTHOLWuhan Ruihengjie Technology Co., Ltd.59a43e2c-d258-34b5-e063-6394a90a09bf2026-08-22WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINPreferred Pharmaceuticals Inc.0fabc025-4208-45f5-b3c2-543ae3a2df412026-08-21WarningsExact identifier
application number: M017
ClaravieHYDROCORTISONE ACETATEGentell LLC598d224b-d12e-89bf-e063-6394a90a84dc2026-08-21WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVINGMENTHOL, CAMPHORWorldwide Cosmetics, Inc3b8c2419-7a78-2731-e054-00144ff8d46c2026-08-21WarningsExact identifier
application number: M017
Enokon Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.5976e667-e506-1d11-e063-6394a90a68092026-08-20WarningsExact identifier
application number: M017
MQUPIN TIGER PatchTIGER PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5977cbb5-94c7-cb24-e063-6294a90a2e072026-08-20WarningsExact identifier
application number: M017
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
application number: M017
ClaravieCAMPHORGentell LLC5978bdab-5359-be9a-e063-6394a90a5a322026-08-20WarningsExact identifier
application number: M017
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsExact identifier
application number: M017
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2694729camphor 3.1 % / capsaicin 0.025 % / menthol 6 % Medicated PatchPSNb6bf1eab-4ab9-f500-e053-2995a90a8d7b4
2694729camphor 0.031 MG/MG / capsaicin 0.00025 MG/MG / menthol 0.06 MG/MG Medicated PatchSCDb6bf1eab-4ab9-f500-e053-2995a90a8d7b4
2694729camphor 3.1 % / capsaicin 0.025 % / menthol 6 % Medicated PatchSYb6bf1eab-4ab9-f500-e053-2995a90a8d7b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-621-01498730621011 POUCH in 1 BOX (49873-621-01) / 5 PATCH in 1 POUCH / 9.36 g in 1 PATCH1 pouch2020-12-180000-00-00NoNoCurrent