FDA.reportPublic FDA data

Real Time Pain Relief Foot Cream

Product NDC
58133-900
11-digit product format
581330900
Labeler code
58133
Product ID
58133-900_61e41c3f-b761-4b3d-e053-2991aa0a3248
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 1.5%
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosmetic Specialty labs, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-01-30
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-900-042024-01-30C16284748780-11030e365-595f-111a-e063-dadaa90a10e2Real Time Pain Relief Foot Cream
58133-900-082024-01-30C16284748780-11030e365-595f-111a-e063-dadaa90a10e2Real Time Pain Relief Foot Cream
58133-900-142024-01-30C16284748780-11030e365-595f-111a-e063-dadaa90a10e2Real Time Pain Relief Foot Cream
58133-900-162024-01-30C16284748780-11030e365-595f-111a-e063-dadaa90a10e2Real Time Pain Relief Foot Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-900-04Real Time Pain Relief Foot CreamTopical Analgesic125 g in 1 JARCREAM1251
58133-900-08Real Time Pain Relief Foot CreamTopical Analgesic227 g in 1 JARCREAM2271
58133-900-14Real Time Pain Relief Foot CreamTopical Analgesic40 g in 1 JARCREAM401
58133-900-16Real Time Pain Relief Foot CreamTopical Analgesic453 g in 1 JARCREAM4531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-900REAL TIME PAIN RELIEF FOOT CREAM TOPICAL ANALGESIC (MENTHOL 1.5%) CREAM [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 4 package rows20180110_61e41c3f-b760-4b3d-e053-2991aa0a3248.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045482menthol 1.5 % Topical CreamPSN61e41c3f-b760-4b3d-e053-2991aa0a32481
1045482menthol 15 MG/ML Topical CreamSCD61e41c3f-b760-4b3d-e053-2991aa0a32481
1045482menthol 1.5 % Topical CreamSY61e41c3f-b760-4b3d-e053-2991aa0a32481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58133-900-0458133090004125 g in 1 JAR (58133-900-04) 125 g2014-01-310000-00-00NoNoCurrent
58133-900-0858133090008227 g in 1 JAR (58133-900-08) 227 g2014-01-310000-00-00NoNoCurrent
58133-900-145813309001440 g in 1 JAR (58133-900-14) 40 g2014-01-310000-00-00NoNoCurrent
58133-900-1658133090016453 g in 1 JAR (58133-900-16) 453 g2014-01-310000-00-00NoNoCurrent