FDA.reportPublic FDA data

Satogesic Hot

Product NDC
49873-608
11-digit product format
498730608
Labeler code
49873
Product ID
49873-608_57efdac6-7c94-5ff1-e063-6294a90adb10
Type
HUMAN OTC DRUG
Nonproprietary name
capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-11-22
Substance
CAPSAICIN
Active strength
.25 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 Hot
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043399Internal RxNorm lookup
1994403Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16b47cb5-ea5f-4514-9a89-141ee4cc60f8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-608-01Satogesic Hot1 in 1 CARTONPATCH15
49873-608-01Satogesic Hot5 in 1 POUCHPATCH55

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
CAPSAICINACTIVE MOIETYS07O44R1ZMSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
ALGELDRATEINACTIVE INGREDIENT03J11K103CSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8SATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
POLYOXYL 60 HYDROGENATED CASTOR OILINACTIVE INGREDIENT02NG325BQGSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
SORBITOLINACTIVE INGREDIENT506T60A25RSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RSATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-608SATOGESIC HOT (CAPSAICIN) PATCH [SATO PHARMACEUTICAL CO., LTD.]5Current NDC, Legacy NDC, 2 package rows20231111_16b47cb5-ea5f-4514-9a89-141ee4cc60f8.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 119 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENGAY Tropical JasmineLIDOCAINEKenvue Brands LLCc416320a-c0d7-401e-b0fa-44114d76a5572024-11-06WarningsExact identifier
application number: M017
Bengay Ultra Strength Large SizeMENTHOL, UNSPECIFIED FORMKenvue Brands LLCf57ccc33-400b-4401-a348-c54d1eb9f5d02024-11-06WarningsExact identifier
application number: M017
Band Aid Antiseptic Cleansing To GoBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd5749cba-32f3-cf9c-e053-2a95a90a44162024-11-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLGOLDEN TIGER DISTRIBUTION L.L.C.26473383-282c-fb10-e063-6394a90a5fa22024-11-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLGOLDEN TIGER DISTRIBUTION L.L.C.1b6f929a-db65-8a02-e063-6394a90a8b592024-11-06WarningsExact identifier
application number: M017
Meijer Maximum Strength Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Incbd6f04f9-a23b-45f6-bce2-1ef7203198e12024-11-06WarningsExact identifier
application number: M017
Meijer Cold and Hot Pain Relieving AnalgesicLIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc6d356563-9098-4994-8ad8-819a8033a9f42024-11-06WarningsExact identifier
application number: M017
TopCare Maximum Strength Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLCdc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab2024-11-05WarningsExact identifier
application number: M017
Aveeno Restorative Skin Therapy Itch Relief BalmPRAMOXINE HYDROCHLORIDEKenvue Brands LLC61824ca7-a2d3-4830-b2bb-149a3222bfc82024-11-05WarningsExact identifier
application number: M017
Aveeno Hydrocortisone ANTI-ITCHHYDROCORTISONEKenvue Brands LLC233de4d7-e533-40cd-a5ed-e8b09abc626e2024-11-05WarningsExact identifier
application number: M017
STING MASTERLIDOCAINE HYDROCHLORIDELes Technologies Ptero, Inc94c6fd1f-9e74-420b-9d25-61b37953b8382024-11-05WarningsExact identifier
application number: M017
Alocane Emergency BurnLIDOCAINE HYDROCHLORIDEQuest Products, LLC.0c8e65a6-dff3-43b4-a3f1-95deb574ea892024-11-05WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35ac19-6883-a733-e063-6294a90ad22d2024-11-05WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.cfe8114b-df65-064b-e053-2a95a90a33f62024-11-05WarningsExact identifier
application number: M017
Alocane BotanicalsLIDOCAINE HYDROCHLORIDEQuest Products, LLC.02a8e5c7-56f4-eb0d-e063-6294a90a80cd2024-11-05WarningsExact identifier
application number: M017
Alocane Emergency Burn PadsLIDOCAINE HYDROCHLORIDEQuest Products, Inc.fe58bb89-7216-4121-afd3-d1438bdfbfa22024-11-05WarningsExact identifier
application number: M017
Licefreee AfterLicePRAMOXINE HCITec Laboratories Inc.06c4cc42-a215-3949-e063-6394a90a665e2024-11-05WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEASO LLCcb9505b7-222d-3a24-e053-2a95a90a0b642024-11-05WarningsExact identifier
application number: M017
TopCare Pain Relieving AnalgesicLIDOCAINE HYDROCHLORIDETopco Associates LLC6b4783e0-1987-4838-9e8c-b95426d62b282024-11-05WarningsExact identifier
application number: M017
Eagle Green BalmCAMPHOR MENTHOLBorden Company (Private) Limited6f7a796b-a31c-0e60-e053-2a91aa0a022b2024-11-04WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSN16b47cb5-ea5f-4514-9a89-141ee4cc60f85
1994403Satogesic Hot 0.025 % Medicated PatchPSN16b47cb5-ea5f-4514-9a89-141ee4cc60f85
1994403capsaicin 0.00025 MG/MG Medicated Patch [Satogesic Hot]SBD16b47cb5-ea5f-4514-9a89-141ee4cc60f85
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD16b47cb5-ea5f-4514-9a89-141ee4cc60f85
1043399capsaicin 0.025 % Medicated PatchSY16b47cb5-ea5f-4514-9a89-141ee4cc60f85
1994403Satogesic Hot 0.025 % Medicated PatchSY16b47cb5-ea5f-4514-9a89-141ee4cc60f85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-608-01498730608011 POUCH in 1 CARTON (49873-608-01) / 5 PATCH in 1 POUCH1 pouch2012-05-170000-00-00NoNoCurrent