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 124 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLC849c60fc-e455-4c50-8adf-ac59c0ee785b2024-10-03WarningsExact identifier
application number: M017
rexall anti itch maximum strength reliefHYDROCORTISONEDolgencorp, LLC894cf9ab-693a-4210-96df-605947f51b632024-10-03WarningsExact identifier
application number: M017
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI070000d7-7d4d-439b-9a91-851ba7c027e62024-10-03WarningsExact identifier
application number: M017
hydrocortisone anti itchHYDROCORTISONEH E Ba1a9fed8-4938-48b5-81f1-d3942d534bb82024-10-03WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFIef9ea069-9b97-4bf5-aaac-deb85334dbd02024-10-03WarningsExact identifier
application number: M017
Basic Care HydrocortisoneHYDROCORTISONEAmazon.com Services LLC7fa13ab4-5f2d-4a48-816f-1b22d5f757b22024-10-03WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEA-S Medication Solutionsdc388dc1-0c4f-4bf1-8a12-fa39892317bc2024-10-02WarningsExact identifier
application number: M017
Geliga MuscularMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAfb2beb08-0ad6-a89d-e053-6294a90aa6fe2024-10-02WarningsExact identifier
application number: M017
Geliga Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAda28097f-4b5c-6159-e053-2a95a90a7d962024-10-02WarningsExact identifier
application number: M017
CircatrixCAPSAICINPureTek Corporationcd3b1256-2df8-dc26-e053-2a95a90ad0492024-10-02WarningsExact identifier
application number: M017
DermacinRx Penetral CreamCAPSAICINPureTek Corporation1e343a52-6071-3230-e054-00144ff8d46c2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEBorden Company (Private) Limited36abfc2c-d424-4df8-968d-866342c96a562024-10-02WarningsExact identifier
application number: M017
Eagle BalmCAMPHOR MENTHOLEagle Indo Pharma, PT87614869-9675-2c76-e053-2a95a90a48a92024-10-02WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedd9a93daa-4e24-6690-e053-2a95a90a147c2024-10-02WarningsExact identifier
application number: M017
Eagle Extra StrengthMENTHOL METHYL SALICYLATEBorden Company (Private) Limited5e02fbe3-5bc7-430e-b661-3a760ddd8fe02024-10-02WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEBorden Company (Private) Limitedc62a4313-2c07-5f58-e053-2995a90a083a2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEEagle Indo Pharma, PTe272ec90-3cd9-5b70-e053-2a95a90a1df42024-10-02WarningsExact identifier
application number: M017
RUGBY HYDROCORTISONE WITH ALOEHYDROCORTISONEA-S Medication Solutionsb2674075-aaa4-4c77-bcaa-a76336b3c3212024-10-02WarningsExact identifier
application number: M017
Herb Street Anti-Itch StickHYDROCORTISONEBalassa Laboratories Inc.8717faae-59c3-4c6f-9ef1-285c0d2445ed2024-10-01WarningsExact identifier
application number: M017
Herb Street Backache and Sore Muscle ReliefMENTHOLBalassa Laboratories Inc.aeac1b64-8689-4b3d-a41c-db41061257b52024-10-01WarningsExact 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