FDA.reportPublic FDA data

Satogesic

Product NDC
49873-060
11-digit product format
498730060
Labeler code
49873
Product ID
49873-060_57efc713-6d19-4b38-e063-6294a90a760e
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
1990-12-03
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
Satogesic
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
cb000134-92a4-4304-8ef0-0347190e1414Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-060-01Satogesic5 in 1 POUCHPATCH55
49873-060-01Satogesic1 in 1 CARTONPATCH15
49873-060-02Satogesic1 in 1 CARTONPATCH15
49873-060-02Satogesic5 in 1 POUCHPATCH55

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
LEVOMENTHOLACTIVE INGREDIENTBZ1R15MTK7SATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
LEVOMENTHOLACTIVE MOIETYBZ1R15MTK7SATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)INACTIVE INGREDIENTM4PPW69Y4HSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
ALGELDRATEINACTIVE INGREDIENT03J11K103CSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT132584PQMOSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
POLYOXYL 60 HYDROGENATED CASTOR OILINACTIVE INGREDIENT02NG325BQGSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
SORBITOLINACTIVE INGREDIENT506T60A25RSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RSATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-060SATOGESIC (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SATO PHARMACEUTICAL CO., LTD.]5Current NDC, Legacy NDC, 4 package rows20231113_cb000134-92a4-4304-8ef0-0347190e1414.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 45 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
application number: M017
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsExact identifier
application number: M017
POMG PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDE, MENTHOLPOMG LLC1fa980fb-fc0e-fdd0-e063-6394a90adc132026-01-07WarningsExact identifier
application number: M017
Artridon GlucosamineMENTHOL, METHYL SALICYLATEPharmadel LLC73572156-4cce-0669-e053-2991aa0aaecc2026-01-07WarningsExact identifier
application number: M017
HealthWise Cooling Pain ReliefMENTHOLVeridian Healthcare6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd2026-01-07WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-Itch CreamHYDROCORTISONEDLC Laboratories, Inc.16eeec2c-065d-4da0-e063-6294a90a38732026-01-07WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
application number: M017
EARTHS CARE MUSCLE AND JOINT RUBCAMPHORDLC Laboratories, Inc.71e33e06-4dc3-4ead-a122-ff89d93a64de2026-01-07WarningsExact identifier
application number: M017
Amour CBDPAIN RELIEF CREAMSVD Premium Products95b45e79-b1e7-17b2-e053-2995a90a88362026-01-07WarningsExact identifier
application number: M017
Tiger Balm Active MuscleMETHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.845a4ead-f9c0-4009-bcae-b17cd388439b2026-01-07WarningsExact identifier
application number: M017
3X Medicated Toothache and Gum GelBENZOCAINERite Aid996f7989-17ce-5b28-e053-2995a90af8b82026-01-06WarningsExact identifier
application number: M017
QNTAMAX Muscle and Joint Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLQntamax LLC6622b94c-824e-4e84-a8d8-b60bb0b866e22026-01-06WarningsExact identifier
application number: M017
Winco Muscle and Joint Pain Relief Gel 2ozWINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEFWINCO FOODS, LLC47bedf4e-4036-cf43-e063-6394a90a91d62026-01-06WarningsExact identifier
application number: M017
Pain Relief Hot PatchMENTHOL AND CAPSAICINUniversal Distribution Center LLC110bcb16-ef0b-4bc8-8877-173a0494e1ad2026-01-06WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact identifier
application number: M017
Lidocaine 4% Topical Anesthetic CreamLIDOCAINE 4%Oncor Pharmaceuticals1baaa669-05af-4024-a0ba-ee3451756f6a2026-01-05WarningsExact identifier
application number: M017
TheraCare Pain ReliefMENTHOLVeridian Healthcare6834a6de-4d1d-4e40-945d-ec5c267abd142026-01-05WarningsExact 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 PatchPSNcb000134-92a4-4304-8ef0-0347190e14145
2669659camphor 0.005 MG/MG / levomenthol 0.004 MG/MG / methyl salicylate 0.008 MG/MG Medicated PatchSCDcb000134-92a4-4304-8ef0-0347190e14145
2669659camphor 0.5 % / levomenthol 0.4 % / methyl salicylate 0.8 % Medicated PatchSYcb000134-92a4-4304-8ef0-0347190e14145

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-060-01498730060011 POUCH in 1 CARTON (49873-060-01) / 5 PATCH in 1 POUCH1 pouch1990-12-030000-00-00NoNoCurrent
49873-060-02498730060021 POUCH in 1 CARTON (49873-060-02) / 5 PATCH in 1 POUCH1 pouch1990-12-030000-00-00NoNoCurrent