FDA.reportPublic FDA data

Satohap

Product NDC
49873-065
11-digit product format
498730065
Labeler code
49873
Product ID
49873-065_0b7d6dc4-82df-04b0-e063-6394a90af9ec
Type
HUMAN OTC DRUG
Nonproprietary name
methyl salicylate, dl-camphor, l-menthol
Dosage form
LOTION
Route
TOPICAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-02-05
Substance
METHYL SALICYLATE; CAMPHOR (SYNTHETIC); LEVOMENTHOL
Active strength
10; 5; 4 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE10 g/100mL
CAMPHOR (SYNTHETIC)5 g/100mL
LEVOMENTHOL4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
5TJD82A1ETInternal UNII lookup
BZ1R15MTK7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860825Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
348fde05-2797-4410-a1b2-99e64187c4feAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-065-01Satohap1 in 1 CARTONLOTION14
49873-065-01Satohap45 mL in 1 BOTTLE, WITH APPLICATORLOTION454

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
LEVOMENTHOLACTIVE INGREDIENTBZ1R15MTK7SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
LEVOMENTHOLACTIVE MOIETYBZ1R15MTK7SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
salicylic acidACTIVE MOIETYO414PZ4LPZSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-065SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) LOTION [SATO PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231203_348fde05-2797-4410-a1b2-99e64187c4fe.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 96 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Pain ReliefMENTHOL 10.5%CVSd0ea80ce-38b2-acde-e053-2995a90a47e52025-03-31WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEA2A Integrated Pharmaceuticals, LLC31431866-6fb5-2acd-e063-6294a90ac5202025-03-31WarningsExact identifier
application number: M017
Citrus Cleansing Foot Soak and Body SoakCAMPHORSANSAR, LLCf136616d-9f32-4e55-a495-b7466fd685262025-03-28WarningsExact identifier
application number: M017
Zpol ULTRAMENTHOL, METHYL SALICYLATELaboratorios Zepol S.A.1a1433a6-8d04-96df-e063-6394a90a987b2025-03-27WarningsExact identifier
application number: M017
Muscle Recovery Foot Soak and Body SoakCAMPHORSANSAR, LLC1c347267-b653-41bf-9967-7feff17c38af2025-03-27WarningsExact identifier
application number: M017
Soothing Lavender Foot Soak and Body SoakCAMPHORSANSAR, LLCef26523a-b2f2-466e-89ad-f293cd64decb2025-03-27WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc31408e21-e58d-6db5-e063-6294a90aa4bc2025-03-26WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc3143bb72-2969-d66e-e063-6294a90a46042025-03-26WarningsExact identifier
application number: M017
Parche LeonCAPSAICIN, CAMPHOR, MENTHOLPharmadel LLCa8f266fa-6e43-559e-e053-2995a90a2c752025-03-26WarningsExact identifier
application number: M017
Adellina Numbing CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.314a83fe-8bdb-766f-e063-6294a90a61c62025-03-26WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus Menthol PatchLIDOCAINE AND MENTHOLVeridian Healthcare312f15fe-9297-2dc2-e063-6294a90a6f4d2025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3130729d-1679-90cd-e063-6294a90a21e62025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare31314dda-6199-574d-e063-6394a90aae7a2025-03-25WarningsExact identifier
application number: M017
RWSEFK Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.31366793-f8a6-a2c4-e063-6294a90acbfc2025-03-25WarningsExact identifier
application number: M017
Forticept Wounds and Burns HydrogelBENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELidan, inc.c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f2025-03-25WarningsExact identifier
application number: M017
MQ Pain Relieving PatchPAIN RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0978ff22-c357-e266-e063-6394a90a98a42025-03-24WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHAdvanced Rx of Tennessee, LLC30c97646-db06-df84-e063-6394a90a77432025-03-20WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e572025-03-20WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPFCAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.5f904369-5f21-4907-98de-df23bce308232025-03-20WarningsExact identifier
application number: M017
DermaCort Anti-itchHYDROCORTISONEMelaleuca, Inc.24044b0f-dd1e-4762-82b8-7a28b08c2f772025-03-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860825camphor 5 % / menthol 4 % / methyl salicylate 10 % Topical LotionPSN348fde05-2797-4410-a1b2-99e64187c4fe4
860825camphor 50 MG/ML / menthol 40 MG/ML / methyl salicylate 100 MG/ML Topical LotionSCD348fde05-2797-4410-a1b2-99e64187c4fe4
860825camphor 5 % / menthol 4 % / methyl salicylate 10 % Topical LotionSY348fde05-2797-4410-a1b2-99e64187c4fe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49873-065-01498730065011 BOTTLE, WITH APPLICATOR in 1 CARTON (49873-065-01) / 45 mL in 1 BOTTLE, WITH APPLICATOR1991-02-050000-00-00NoNoCurrent