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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
232a4c76-1a0c-2f4b-e063-6394a90a8849	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

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 75 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AREX SINSIN PAS	CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE	Sinsin Pharmaceutical Co., Ltd.	2013ea44-e2ea-4b36-bddb-7f64163284b6	2025-10-07	Warnings	Exact identifier application number: M017
SINSINPAS LIDOCAINE PAIN RELIEVING	LIDOCAINE	Sinsin Pharmaceutical Co., Ltd.	82c0a036-8750-5b3d-e053-2a91aa0a1815	2025-10-07	Warnings	Exact identifier application number: M017
SINSIN MULPAS	L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOL	Sinsin Pharmaceutical Co., Ltd.	81baffcb-c08e-4616-e053-2a91aa0aaf15	2025-10-07	Warnings	Exact identifier application number: M017
Arex Sinsin Pas	CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE	Sinsin Pharmaceutical Co., Ltd.	a851854a-5dfe-4bd5-95f6-67c3f13f1187	2025-10-07	Warnings	Exact identifier application number: M017
Sinsinpas Arex Flex Gel Pain Relieving Patch	L-MENTHOL	Sinsin Pharmaceutical Co., Ltd.	1758ef9b-4fac-4066-e063-6394a90a8cc3	2025-10-07	Warnings	Exact identifier application number: M017
SINSINPAS CORN REMOVER	SALICYLIC ACID	Sinsin Pharmaceutical Co., Ltd.	e2771dfc-ee57-553f-e053-2a95a90af281	2025-10-07	Warnings	Exact identifier application number: M017
Feminine Anti-Itch Creme	BENZOCAINE, RESORCINOL	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	aa6cc963-dc60-5222-e053-2995a90acaf6	2025-10-06	Warnings	Exact identifier application number: M017
TheraCare 2% Diphenhydramine Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Veridian Healthcare	5999b677-63dd-49c6-b5b8-7b3c117ecc5c	2025-10-06	Warnings	Exact identifier application number: M017
HealthWise Pain Relief	MENTHOL	Veridian Healthcare	06be5331-7a1e-4ab3-9f17-2d350bd4b890	2025-10-02	Warnings	Exact identifier application number: M017
equate Burn Relief	LIDOCAINE HYDROCHLORIDE	Walmart Inc	a90cbd92-80a5-4463-8152-b83165121a6f	2025-10-02	Warnings	Exact identifier application number: M017
AsperFlex HOT	CAMPHOR, MENTHOL, METHYL SALICYLATE	Akron Pharma Inc.	a6cb0656-8866-44ff-b40c-73655ff68721	2025-10-02	Warnings	Exact identifier application number: M017
AsperFlex Original Maximum Strength	MENTHOL	Akron Pharma Inc.	d766c61e-c48b-4aff-97b0-678159479e03	2025-10-02	Warnings	Exact identifier application number: M017
HealthWise Feminine Anti-Itch Cream	BENZOCAINE, RESORCINOL	Veridian Healthcare	1f9110da-f448-8e20-e063-6294a90a4275	2025-10-02	Warnings	Exact identifier application number: M017
PROSTAT FIRST AID Burn Ease, 0.9g	LIDOCAINE	ProStat First Aid LLC	dc704403-e2aa-47f7-a7f4-f6afe1547ca8	2025-10-01	Warnings	Exact identifier application number: M017
PROSTAT FIRST AID Burn Ease, 0.9g	LIDOCAINE	ProStat First Aid LLC	e02558a9-fe2b-4f28-9fd3-7308f859d759	2025-10-01	Warnings	Exact identifier application number: M017
FL Burn Ease, 0.9g	LIDOCAINE	ProStat First Aid LLC	4dc0d579-ab42-4ea5-9788-5e54d7d318a3	2025-10-01	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	c7a7626c-cf82-4301-af79-c5e85367e777	2025-10-01	Warnings	Exact identifier application number: M017
Viaderma Calm Anti-Itch	HYDROCORTISONE	ViaDerma Distribution, Inc.	7afa2ccd-bfc6-48fc-9a14-a0c6d645844e	2025-10-01	Warnings	Exact identifier application number: M017
AsperFlex Advance	CAMPHOR, MENTHOL, METHYL SALICYLATE	Akron Pharma Inc.	d23d7f2b-4dcd-4c31-9d12-340f233018b4	2025-10-01	Warnings	Exact identifier application number: M017
HEATING PAIN RELIEF	METHYL SALICYLATE, MENTHOL	SUNSET NOVELTIES, INC	4024d604-c8c7-2d73-e063-6294a90a2e80	2025-10-01	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
BZ1R15MTK7	LEVOMENTHOL	2216-51-5	LEVOMENTHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2694729	camphor 3.1 % / capsaicin 0.025 % / menthol 6 % Medicated Patch	PSN	232a4c76-1a0c-2f4b-e063-6394a90a8849	1
2694729	camphor 0.031 MG/MG / capsaicin 0.00025 MG/MG / menthol 0.06 MG/MG Medicated Patch	SCD	232a4c76-1a0c-2f4b-e063-6394a90a8849	1
2694729	camphor 3.1 % / capsaicin 0.025 % / menthol 6 % Medicated Patch	SY	232a4c76-1a0c-2f4b-e063-6394a90a8849	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SATOHAP Cool & Hot - 5 pads in 1 pouch - (10cm BY 7cm each pad)	Sato Pharmaceuticals Co., Ltd.	2026-07-31	HUMAN OTC DRUG LABEL	2