FDA.reportPublic FDA data

SMART PRO

Product NDC
76092-101
11-digit product format
760920101
Labeler code
76092
Product ID
76092-101_fd8d9ad8-bfeb-49b9-90e7-37cf335a8cb5
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
M J Winston International Ltd..
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-07-01
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
1 mg/1; mg/1; mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76092-101-052020-01-31C16284748780-19d75b9d0-b521-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76092-101-05SMART PROMEDICATED ANALGESIC PAIN RELIEVING CATAPLASM5 in 1 POUCHPATCH51

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ASMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
MENTHOLACTIVE MOIETYL7T10EIP3ASMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
ALMASILATEINACTIVE INGREDIENTOZQ8O62H53SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
GELATININACTIVE INGREDIENT2G86QN327LSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
KAOLININACTIVE INGREDIENT24H4NWX5COSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341LSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ASMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
WATERINACTIVE INGREDIENT059QF0KO0RSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76092-101SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1Legacy NDC, 1 package rows20110701_ad334d10-9053-4c40-96a5-db7236564542.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717562camphor 1.2 % / levomenthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSNad334d10-9053-4c40-96a5-db72365645421
2717562camphor 0.012 MG/MG / levomenthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCDad334d10-9053-4c40-96a5-db72365645421
2717562camphor 1.2 % / levomenthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSYad334d10-9053-4c40-96a5-db72365645421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76092-101-05760920101055 in 1 POUCHHistorical