FDA.reportPublic FDA data

Alcis Daily Relief Pain Relief

Product NDC
58132-3331
11-digit product format
581323331
Labeler code
58132
Product ID
58132-3331_c2b362c3-36dc-40ef-91be-242d45a09b47
Type
HUMAN OTC DRUG
Nonproprietary name
Trolamine Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Alcis Topical, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-03-09
Marketing end
0000-00-00
Substance
TROLAMINE SALICYLATE
Active strength
10 g/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58132-3331-22020-01-31C16284748780-19d75b9d0-7684-f424-e053-dadaa90a57ceDrug Facts
58132-3331-32020-01-31C16284748780-19d75b9d0-7684-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58132-3331-2Alcis Daily Relief Pain Relief59.1 mL in 1 TUBECREAM59.12
58132-3331-2Alcis Daily Relief Pain Relief1 in 1 CARTONCREAM12
58132-3331-3Alcis Daily Relief Pain Relief88.7 mL in 1 TUBECREAM88.72
58132-3331-3Alcis Daily Relief Pain Relief1 in 1 CARTONCREAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TROLAMINE SALICYLATEACTIVE INGREDIENTH8O4040BHDALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C60ALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
GLUCOSAMINE SULFATEINACTIVE INGREDIENT1FW7WLR731ALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
IMIDUREAINACTIVE INGREDIENTM629807ATLALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
LAVANDULA ANGUSTIFOLIA FLOWERING TOPINACTIVE INGREDIENT9YT4B71U8PALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9ALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
ROSEMARYINACTIVE INGREDIENTIJ67X351P9ALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXAALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58132-3331ALCIS DAILY RELIEF PAIN RELIEF (TROLAMINE SALICYLATE) CREAM [ALCIS TOPICAL, INC.]2Legacy NDC, 4 package rows20140207_b5b1f3a2-7fba-4c2e-aee9-a0bf28ae1364.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313518trolamine salicylate 10 % Topical CreamPSNb5b1f3a2-7fba-4c2e-aee9-a0bf28ae13642
313518trolamine salicylate 100 MG/ML Topical CreamSCDb5b1f3a2-7fba-4c2e-aee9-a0bf28ae13642
313518trolamine salicylate 10 % Topical CreamSYb5b1f3a2-7fba-4c2e-aee9-a0bf28ae13642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58132-3331-25813233310259.1 mL in 1 TUBE59.1 mlHistorical
58132-3331-35813233310388.7 mL in 1 TUBE88.7 mlHistorical