Cold Spot

Product NDC
51452-004
11-digit product format
514520004
Labeler code
51452
Product ID
51452-004_2409526b-8656-40bd-aacc-92ed34dbae76
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
SWAB
Route
TOPICAL
Labeler
Fabrication Enterprises, inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-10-13
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
1 mL/8mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51452-004-002019-11-13C16284748780-197449f38-b5f1-f6ea-e053-dbdaa90aa703coldspot point relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51452-004-00Cold SpotPoint Relief8 mL in 1 PACKETSWAB84

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
MentholACTIVE MOIETYL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
alcoholINACTIVE INGREDIENT3K9958V90MCOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZCOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
BOSWELLIA SERRATA RESIN OILINACTIVE INGREDIENT5T1XCE6K8KCOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
BROMELAINSINACTIVE INGREDIENTU182GP2CF3COLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
Chondroitin sulfate (bovine)INACTIVE INGREDIENT6IC1M3OG5ZCOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
Citric AcidINACTIVE INGREDIENT2968PHW8QPCOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FTCOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
Eucalyptus Globulus leafINACTIVE INGREDIENTS546YLW6E6COLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FCOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302COLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
Peppermint OilINACTIVE INGREDIENTAV092KU4JHCOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4
WATERINACTIVE INGREDIENT059QF0KO0RCOLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51452-004COLD SPOT POINT RELIEF (MENTHOL) SWAB [FABRICATION ENTERPRISES, INC. ]4Legacy NDC, 1 package rows20111025_22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235986Cold Spot Point Relief 12 % Medicated PadPSN22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d4
1191164menthol 12 % Medicated PadPSN22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d4
1235986menthol 120 MG/ML Medicated Pad [Cold Spot]SBD22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d4
1191164menthol 120 MG/ML Medicated PadSCD22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d4
1235986Cold Spot 120 MG/ML Medicated PadSY22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d4
1235986Cold Spot Point Relief 12 % Medicated PadSY22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d4
1191164menthol 12 % Medicated WipeSY22c737d7-ccff-4c00-8ee1-6ab9f4a6b18d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51452-004-00514520004008 mL in 1 PACKET8 mlHistorical