FDA.reportPublic FDA data

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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
application number: M017
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a5b47ce-2bf1-42c7-e063-6294a90af09f2026-07-23WarningsExact identifier
application number: M017
DERMFREE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c63b3-44de-8736-e063-6394a90ac21a2026-07-23WarningsExact identifier
application number: M017
DERMFREE Anti-itchHYDROCORTISONE1% ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a5af4c6-555a-e74c-e063-6394a90aa6ce2026-07-23WarningsExact identifier
application number: M017
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
application number: M017
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
application number: M017
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
application number: M017
Numbing Pain ReliefLIDOCAINE 4%Walgreen Company2425badb-e196-e9f8-e063-6294a90a7bf42026-07-22WarningsExact identifier
application number: M017
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
application number: M017
Heat Pain ReliefCAPSAICIN 0.1%Walgreen Company2434f9cf-74aa-17af-e063-6294a90a56d92026-07-22WarningsExact identifier
application number: M017
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsExact identifier
application number: M017
CVS Ultra Strength MuscleMENTHOL, CAMPHOR, METHYL SALICYLATECVS Pharmacy48bef8bc-6e39-a328-e063-6394a90ae4502026-07-22WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative573c2d85-9e0b-7955-e063-6394a90aff642026-07-22WarningsExact identifier
application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
application number: M017
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact 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