FDA.reportPublic FDA data

Salonpas

Product NDC
46581-110
11-digit product format
465810110
Labeler code
46581
Product ID
46581-110_3a5fdf2d-359f-47bc-bba2-80674cef19cf
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl salicylate
Dosage form
PATCH
Route
PERCUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Hisamitsu Pharmaceutical Co., Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
21.56; 41.73; 69.55 mg/1; mg/1; mg/1
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
Salonpas
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)21.56 mg/1
MENTHOL41.73 mg/1
METHYL SALICYLATE69.55 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
L7T10EIP3AInternal 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
1793147Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
acdd5622-a9a7-4cc3-877e-57efea23303fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46581-110-14Salonpas20 in 1 POUCHPATCH209
46581-110-14Salonpas7 in 1 BOXPATCH79
46581-110-20Salonpas20 in 1 POUCHPATCH209
46581-110-20Salonpas1 in 1 BOXPATCH19
46581-110-60Salonpas20 in 1 POUCHPATCH209
46581-110-60Salonpas3 in 1 BOXPATCH39
46581-110-99Salonpas2 in 1 POUCHPATCH29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46581-110-20EA - Each46581-110e01f4fa0-af82-4a78-880d-d1a731e1360a12020-07-13
46581-110-60EA - Each46581-110324efea9-ebf1-4441-8cdc-97ae0a684d9a12020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2
MENTHOLACTIVE INGREDIENTL7T10EIP3ASALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YSALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3ASALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2
ALUMINUM SILICATEINACTIVE INGREDIENTT1FAD4SS2MSALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46581-110SALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]9Current NDC, Legacy NDC, 7 package rows20241205_acdd5622-a9a7-4cc3-877e-57efea23303f.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 86 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULTRA STRENGTH ZHENG GU SHUIMENTHOL AND CAMPHORGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD53397663-044d-4e48-989b-2c6257af5f842025-07-14Warnings, Adverse reactionsExact identifier
application number: M017
TIGER BALM PAIN RELIEVING HYDROGELCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.cb60037f-bceb-4090-a5e4-bdda0cbf9f5c2025-07-14WarningsExact identifier
application number: M017
Avedana Hydrocortisone Cream with AloeHYDROCORTISONEUnipack LLC2a55c426-39b4-4d94-b6b4-6c548c9685e92025-07-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATERite Aid Corporationcb6e0bed-2ea1-49d2-89e7-2554e7565b742025-07-11WarningsExact identifier
application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll OnLIDOCAINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c42025-07-11WarningsExact identifier
application number: M017
Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETARGET Corporation6fba5890-f48f-4302-a8ac-5087a6e03bd52025-07-11WarningsExact identifier
application number: M017
TopCare Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC55dc4025-f07f-41b2-8b18-6a11ee04b5cc2025-07-11WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC309d9be0-e367-429a-a1fa-ab7855477c8a2025-07-10WarningsExact identifier
application number: M017
Bengay Vanishing ScentMENTHOL, UNSPECIFIED FORMKenvue Brands LLC6cc3294b-3b0f-44d0-af71-61db1022d2692025-07-10WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLQuality Choicece544a7c-8dc6-4e63-b499-d8a4e0ec48c32025-07-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATEWalgreen Companybff322f1-59c3-41e0-8685-fcfe52bf4b422025-07-10WarningsExact identifier
application number: M017
CVS CortisoneHYDROCORTISONECVS Pharmacy87631be8-94b8-4718-858d-d2f30e636cce2025-07-10WarningsExact identifier
application number: M017
TopCare Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETopco Associates LLCc40e8e1d-d6d7-4880-99d3-011b97a5e4f32025-07-10WarningsExact identifier
application number: M017
Live Better Hydrocortisone with AloeHYDROCORTISONEThe Great Atlantic & Pacific Tea Company044e6ee2-98a6-4802-b33d-78b8551356c42025-07-10WarningsExact identifier
application number: M017
Rocainol TOPICAL ANALGESICMETHYL SALICYLATE, MENTHOLCompania Internacional de Comercio, S.A.P.I de C.V.827ec7b2-3d87-47e0-a47a-966b25732c322025-07-10WarningsExact identifier
application number: M017
NumbR-XLIDOCAINE HCLProdigy Media Inc16329ab6-4a33-4c38-85e0-5aad9c75d61d2025-07-10WarningsExact identifier
application number: M017
Dr LidoLIDOCAINE HCLProdigy Media Incda0938f0-00e7-4502-8721-d64c71f594fc2025-07-10WarningsExact identifier
application number: M017
Pain Relief PatchCAMPHOR, METHYL SALICYLATE, MENTHOLCDMA, Inc.da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b2025-07-09WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5%MENTHOLLiquidCapsule Manufacturing LLC4fd4b7ac-1971-4abe-8fbb-74ab69e120612025-07-09WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEAmerisourceBergenf36acdb8-a526-4bb7-a557-e1dcbbc1cf452025-07-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSNacdd5622-a9a7-4cc3-877e-57efea23303f9
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCDacdd5622-a9a7-4cc3-877e-57efea23303f9
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSYacdd5622-a9a7-4cc3-877e-57efea23303f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46581-110-14465810110147 POUCH in 1 BOX (46581-110-14) / 20 PATCH in 1 POUCH7 pouch2016-08-010000-00-00NoNoCurrent
46581-110-20465810110201 POUCH in 1 BOX (46581-110-20) / 20 PATCH in 1 POUCH1 pouch2015-12-010000-00-00NoNoCurrent
46581-110-60465810110603 POUCH in 1 BOX (46581-110-60) / 20 PATCH in 1 POUCH3 pouch2015-06-010000-00-00NoNoCurrent
46581-110-99465810110992 PATCH in 1 POUCH (46581-110-99) 2 patch2015-07-010000-00-00NoNoCurrent