Satohap

Product NDC
49873-018
11-digit product format
498730018
Labeler code
49873
Product ID
49873-018_57ef197a-23c6-464a-e063-6394a90afe17
Type
HUMAN OTC DRUG
Nonproprietary name
dl-camphor, l-menthol, methyl salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-11-08
Substance
CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE
Active strength
5; 4; 8 mg/1; mg/1; mg/1
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)5 mg/1
LEVOMENTHOL4 mg/1
METHYL SALICYLATE8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2669659Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df0e2b83-8f61-4ed8-bcc4-55e4ea782090Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-018-02Satohap5 in 1 POUCHPATCH54
49873-018-02Satohap1 in 1 CARTONPATCH14
49873-018-05Satohap5 in 1 POUCHPATCH54
49873-018-05Satohap1 in 1 CARTONPATCH14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
LEVOMENTHOLACTIVE INGREDIENTBZ1R15MTK7SATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
LEVOMENTHOLACTIVE MOIETYBZ1R15MTK7SATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
ALGELDRATEINACTIVE INGREDIENT03J11K103CSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
POLYOXYL 60 HYDROGENATED CASTOR OILINACTIVE INGREDIENT02NG325BQGSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
SORBITOLINACTIVE INGREDIENT506T60A25RSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RSATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-018SATOHAP (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 4 package rows20231113_df0e2b83-8f61-4ed8-bcc4-55e4ea782090.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 138 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MED O-3 BIO-METHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC02707552-03d9-3ad2-e063-6294a90a34722024-01-06WarningsExact identifier
application number: M017
Sumifun Knee Relieving PatchKNEE RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e7e73ec-ab33-9235-e063-6394a90ad9502024-01-06WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINEYYBA Corpde6dc194-c6ef-4cb5-be3f-e772ace9abaf2024-01-03WarningsExact identifier
application number: M017
Equate Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMWalmart Inc.0cdc9323-f5c3-468c-a7ae-83dfd2d766262024-01-03WarningsExact identifier
application number: M017
OWELL NATURALS Deep Penetrating Pain ReliefMENTHOLOWELL NATURALS BRAND, LLCb36eb017-ed8d-476e-994b-22b275e005432024-01-02WarningsExact identifier
application number: M017
DibucaineDIBUCAINE 1%Trifecta Pharmaceuticals USA LLCe8a56651-a292-7609-e053-2a95a90a7c362024-01-02WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Trifecta Pharmaceuticals USA, LLC.44d17651-a31b-64ca-e054-00144ff8d46c2024-01-02WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.e0a13344-5493-eb51-e053-2995a90a81832024-01-02WarningsExact identifier
application number: M017
Sumifun Knee Relieve PatchKNEE RELIEVE PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e031aa5-edf4-8c9d-e063-6394a90afee32024-01-02WarningsExact identifier
application number: M017
OKeeffes Healthy FeetALLANTOIN, LIDOCAINEThe Gorilla Glue Company/O'Keeffe's Companyd73709db-3932-3c56-e053-2995a90a7d0a2024-01-01WarningsExact identifier
application number: M017
PERSONAL CARE ICE COLDMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.1994356c-e347-5b7d-e063-6394a90a476c2024-01-01WarningsExact identifier
application number: M017
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINProficient Rx LP7e765fc1-74c6-4af3-a9cf-05b57011d7d82024-01-01WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Incc6a0880e-fc16-46e9-8314-c56c9d15bf312023-12-31WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Anti ItchHYDROCORTISONEL'Oreal USA Products Inc.8d65e945-2557-486f-9279-ecbaa08f31c42023-12-31WarningsExact identifier
application number: M017
Nighttime Sleep-Aid Non-Habit FormingDIPHENHYDRAMINE HCIAptaPharma Inc.ed0ba7aa-e794-43da-b576-6b9945bf74772023-12-30WarningsExact identifier
application number: M017
Sting-KillBENZOCAINE AND MENTHOLRANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTHb8bd9280-f20a-4b2a-aef7-a0ba7b3b87012023-12-29WarningsExact identifier
application number: M017
Maybelline New York Baby Lips Dr Rescue Medicated BalmMENTHOLL'Oreal USA Products Inc2f7b8221-66f6-4aed-8359-318cfc656a722023-12-28WarningsExact identifier
application number: M017
Equate CortisoneHYDROCORTISONE 1%Walmart Inc027fae33-93a0-a61f-e063-6294a90a990f2023-12-27WarningsExact identifier
application number: M017
Walgreens Cool n Heat LidocaineLIDOCAINE HCL 4%Walgreens Co0681c6c5-5a8b-ea9e-e063-6394a90a83bc2023-12-27WarningsExact identifier
application number: M017
EXTRA STRENGTH WAL-DRYL ITCH RELIEFDIPHENHYDRAMINE, ZINC ACETATEWALGREEN CO681cf1af-2cc3-4e6d-b76f-f00731ea3e122023-12-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2669659camphor 0.5 % / levomenthol 0.4 % / methyl salicylate 0.8 % Medicated PatchPSNdf0e2b83-8f61-4ed8-bcc4-55e4ea7820904
2669659camphor 0.005 MG/MG / levomenthol 0.004 MG/MG / methyl salicylate 0.008 MG/MG Medicated PatchSCDdf0e2b83-8f61-4ed8-bcc4-55e4ea7820904
2669659camphor 0.5 % / levomenthol 0.4 % / methyl salicylate 0.8 % Medicated PatchSYdf0e2b83-8f61-4ed8-bcc4-55e4ea7820904

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-018-02498730018021 POUCH in 1 CARTON (49873-018-02) / 5 PATCH in 1 POUCH1 pouch1989-11-080000-00-00NoNoCurrent
49873-018-05498730018051 POUCH in 1 CARTON (49873-018-05) / 5 PATCH in 1 POUCH1 pouch1989-11-080000-00-00NoNoCurrent