FDA.reportPublic FDA data

Satohap

Product NDC
49873-068
11-digit product format
498730068
Labeler code
49873
Product ID
49873-068_0b3fe183-c97d-44d8-e063-6294a90a67cd
Type
HUMAN OTC DRUG
Nonproprietary name
methyl salicylate, dl-camphor, l-menthol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-11-03
Substance
METHYL SALICYLATE; LEVOMENTHOL; CAMPHOR (SYNTHETIC)
Active strength
10; 4; 5 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
LEVOMENTHOL4 g/100mL
CAMPHOR (SYNTHETIC)5 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
BZ1R15MTK7Internal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1249174Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecfAvailable on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49873-068-022023-05-16C16284748780-1f386c649-ec97-0266-e053-dadaa90a7c1aSatohap Spray
49873-068-022023-01-30C16284748780-1f386c649-ec97-0266-e053-dadaa90a7c1aSatohap Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-068-02Satohap70 mL in 1 CANISTERSPRAY706

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]2
LEVOMENTHOLACTIVE INGREDIENTBZ1R15MTK7SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]2
LEVOMENTHOLACTIVE MOIETYBZ1R15MTK7SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]2
LIQUEFIED PETROLEUM GASINACTIVE INGREDIENT5K616HU99VSATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]2
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-068SATOHAP (METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL) SPRAY [SATO PHARMACEUTICAL CO., LTD.]6Current NDC, Legacy NDC, 1 package rows20231129_3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf.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 63 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4x Medicated Toothache and Gum CreamBENZOCAINEKrogera8c5090a-24f9-4e73-e053-2a95a90acca02025-11-14WarningsExact identifier
application number: M017
PM Toothache ReliefBENZOCAINECVS0a5a8cd0-d680-8a0f-e063-6294a90aa65c2025-11-14WarningsExact identifier
application number: M017
PM Toothache ReliefBENZOCAINEWalgreense816f742-fba9-3c12-e053-2a95a90a192f2025-11-14WarningsExact identifier
application number: M017
4x Medicated Toothache and Gum CreamBENZOCAINEWalgreensa71c2092-4ece-b82e-e053-2995a90ac9332025-11-14WarningsExact identifier
application number: M017
After Bite OutdoorDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands22b891a9-6386-dee1-e063-6394a90a5c2f2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger3f881349-fcdd-e276-e063-6394a90ae49e2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434cb8b2-a996-5360-e063-6394a90ada032025-11-13WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED4360e3ec-7a4b-b28e-e063-6294a90a0bd62025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED4360e3be-0ec4-cd57-e063-6394a90aca632025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED43616ad7-58bb-e5ad-e063-6394a90a192b2025-11-13WarningsExact identifier
application number: M017
4x Medicated Severe Toothache and Gum GelBENZALKONIUM CHLORIDEMeijer97ce7890-5093-1763-e053-2a95a90afae72025-11-13WarningsExact identifier
application number: M017
Pain RelieverCAMPHOR, MENTHOLKool 'N Fit Inc.2253f6bd-5707-b993-e063-6394a90aa74a2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED4360e0d1-46cd-ab4b-e063-6394a90a55e12025-11-12WarningsExact identifier
application number: M017
CVS Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECVS8723e097-296f-784a-e053-2991aa0a552e2025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154d8821-3e76-b0e2-e063-6294a90ae0772025-11-12WarningsExact identifier
application number: M017
Good neighbor Pharmacy Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEAMERISOURCEBERGEN DRUG CORPORATION87395273-380c-7cef-e053-2991aa0a54c62025-11-12WarningsExact identifier
application number: M017
Quality Choice Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEChain Drug Marketing Association8735b298-83f3-0b5d-e053-2a91aa0a82922025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.1550e794-b3c0-4769-e063-6294a90a8c2d2025-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249174camphor 5 % / menthol 4 % / methyl salicylate 10 % Topical SprayPSN3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf6
1249174camphor 50 MG/ML / menthol 40 MG/ML / methyl salicylate 100 MG/ML Topical SpraySCD3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf6
1249174camphor 5 % / menthol 4 % / methyl salicylate 10 % Topical SpraySY3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-068-024987300680270 mL in 1 CANISTER (49873-068-02) 70 ml2006-11-030000-00-00NoNoCurrent