FDA.reportPublic FDA data

Allure Ice Cold Analgesic

Product NDC
52000-004
11-digit product format
520000004
Labeler code
52000
Product ID
52000-004_da83c7c6-bf57-4c6e-bb44-d76c14c8cacc
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Camphor
Dosage form
GEL
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-06-30
Marketing end
0000-00-00
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
1 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-004-132020-01-31C16284748780-19d75b9d0-981d-f424-e053-dadaa90a57ceALLURE ICE COLD ANALGESIC GEL
52000-004-142020-01-31C16284748780-19d75b9d0-981d-f424-e053-dadaa90a57ceALLURE ICE COLD ANALGESIC GEL
52000-004-152020-01-31C16284748780-19d75b9d0-981d-f424-e053-dadaa90a57ceALLURE ICE COLD ANALGESIC GEL
52000-004-162020-01-31C16284748780-19d75b9d0-981d-f424-e053-dadaa90a57ceALLURE ICE COLD ANALGESIC GEL
52000-004-172020-01-31C16284748780-19d75b9d0-981d-f424-e053-dadaa90a57ceALLURE ICE COLD ANALGESIC GEL
52000-004-182020-01-31C16284748780-19d75b9d0-981d-f424-e053-dadaa90a57ceALLURE ICE COLD ANALGESIC GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-004-13Allure Ice Cold Analgesic170 g in 1 BOTTLE, PLASTICGEL1702
52000-004-14Allure Ice Cold Analgesic226 g in 1 BOTTLE, PLASTICGEL2262
52000-004-15Allure Ice Cold Analgesic300 g in 1 BOTTLE, PLASTICGEL3002
52000-004-16Allure Ice Cold Analgesic500 g in 1 BOTTLE, PLASTICGEL5002
52000-004-17Allure Ice Cold Analgesic127 g in 1 TUBEGEL1272
52000-004-18Allure Ice Cold Analgesic170 g in 1 TUBEGEL1702

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
MENTHOLACTIVE MOIETYL7T10EIP3AALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208ALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-004ALLURE ICE COLD ANALGESIC (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2Legacy NDC, 6 package rows20120727_ab166351-93b7-4707-9b4b-aa404ef4e39e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043046camphor 0.5 % / menthol 1 % Topical GelPSNab166351-93b7-4707-9b4b-aa404ef4e39e2
1043046camphor 0.005 MG/MG / menthol 0.01 MG/MG Topical GelSCDab166351-93b7-4707-9b4b-aa404ef4e39e2
1043046camphor 0.5 % / menthol 1 % Topical GelSYab166351-93b7-4707-9b4b-aa404ef4e39e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52000-004-1352000000413170 g in 1 BOTTLE, PLASTIC170 gHistorical
52000-004-1452000000414226 g in 1 BOTTLE, PLASTIC226 gHistorical
52000-004-1552000000415300 g in 1 BOTTLE, PLASTIC300 gHistorical
52000-004-1652000000416500 g in 1 BOTTLE, PLASTIC500 gHistorical
52000-004-1752000000417127 g in 1 TUBE127 gHistorical
52000-004-1852000000418170 g in 1 TUBE170 gHistorical