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 107 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DCH Calaspray Itch ReliefPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Derma Care Research Labs, LLCfda2afaf-3cd0-92b3-e053-6394a90a74932024-12-19WarningsExact identifier
application number: M017
DCH Nerve Pain Relief Roll-OnLIDOCAINE HCL 4%, MENTHOL 1%Derma Care Research Labs, LLCff32cbb2-79eb-9158-e053-6394a90ac3572024-12-19WarningsExact identifier
application number: M017
DCH Burn ReliefLIDOCAINE, 0.5%Derma Care Research Labsffd7be08-0510-dfcb-e053-6394a90ad2862024-12-19WarningsExact identifier
application number: M017
DCH Arthritis Pain Relief Roll-OnCAPSAISIN 0.1%Derma Care Research Labs, LLCfda0d359-95eb-8b38-e053-6294a90a7b882024-12-19WarningsExact identifier
application number: M017
DCH Pain RelievingMENTHOL 2%Derma Care Research Labs, LLCff49ee63-6a87-c7a7-e053-6294a90a77a32024-12-19WarningsExact identifier
application number: M017
Warrior Pain Relief Roll-On Maximum StrengthLIDOCAINE HCL 4%Derma Care Research Labs, LLCdd80e560-6467-2166-e053-2995a90a88a82024-12-19WarningsExact identifier
application number: M017
DCH Labs Cool and Heat Roll-OnMENTHOL 16%Derma Care Research Labs, LLCd35d7720-44ce-3624-e053-2995a90a7fb42024-12-19WarningsExact identifier
application number: M017
Dr Goldsons PainMENTHOL 8%, METHYL SALICYLATE 30%Derma Care Research Labs, LLCfb34b0d3-ccc0-305e-e053-6394a90a231d2024-12-19WarningsExact identifier
application number: M017
Warrior Pain RelievingCAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30%Derma Care Research Labs, LLCdd06af3c-5452-9759-e053-2a95a90afc212024-12-19WarningsExact identifier
application number: M017
Warrior Burn Relief Aloe Maximum StrengthLIDOCAINE HCL 4%Derma Care Research Labs, LLCec6efa4b-dcbe-1c2b-e053-2995a90ae0432024-12-19WarningsExact identifier
application number: M017
DCH Arthritis ReliefTROLAMIN SALICYLATE 10%Derma Care Research Labs, LLCff31e515-5780-b77d-e053-6394a90af6b92024-12-19WarningsExact identifier
application number: M017
DCH Pain ReliefLIDOCAINE 4%Derma Care Research Labs, LLC00efda74-d434-04be-e063-6294a90a6d982024-12-19WarningsExact identifier
application number: M017
Dollar General Cold Therapy Pain ReliefMENTHOL 5%Dolgencorp, LLCff3284d1-e73c-93bf-e053-6294a90aaf4e2024-12-19WarningsExact identifier
application number: M017
Dollar General Pain Relieving Patch with LidocaineLIDOCAINEDOLGENCORP, LLC55828cd1-3a1e-48ac-bb01-4c50b96d09a22024-12-19WarningsExact identifier
application number: M017
DCH Nerve Pain ReliefLIDOCAINE 4%, MENTHOL 1%Derma Care Research Labs, LLC00db480a-e510-a64d-e063-6394a90a46952024-12-19WarningsExact identifier
application number: M017
Pain, Burn, and Itch ReliefBENZOCAINE 20%, MENTHOL 0.5%Derma Care Research Labs, LLCfd9fe09f-3ae9-c5f5-e053-6394a90ad6912024-12-19WarningsExact identifier
application number: M017
DCH Cooling Pain ReliefMENTHOL 4%Derma Care Research Labs, LLC00ed3175-c3ba-6545-e063-6394a90acfd12024-12-19WarningsExact identifier
application number: M017
DCH Pain ReliefLIDOCAINE HCL 4%Derma Care Research Labs, LLC00dd70f3-ecc3-33ba-e063-6294a90a4f322024-12-19WarningsExact identifier
application number: M017
Walgreens Kinesiology Pain ReliefLIDOCAINE, MENTHOLWalgreen Co.0fdbb310-8e65-4e0c-b413-a093964324a22024-12-19WarningsExact identifier
application number: M017
Signature Care Medicated Cold and Hot PatchMENTHOLSafeway0335f1b3-5c8a-67b8-e063-6294a90a98472024-12-19WarningsExact 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