FDA.reportPublic FDA data

Cold Spot

Product NDC
51452-001
11-digit product format
514520001
Labeler code
51452
Product ID
51452-001_8bdc5379-f2d4-4c2b-affa-8fdd375c7713
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, methyl salicylate
Dosage form
GEL
Route
TOPICAL
Labeler
Fabrication Enterprises
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-08-24
Marketing end
0000-00-00
Substance
MENTHOL; METHYL SALICYLATE
Active strength
58 mL/480mL; mL/480mL
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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51452-001-002019-10-29C16284748780-1960f7f55-cdd9-8e05-e053-dbdaa90a074aCold Spot Point Relief Pain relieving Gel - 5 G
51452-001-042019-10-29C16284748780-1960f7f55-cd55-8e05-e053-dbdaa90a074aCold Spot Point Relief Pain relieving Gel - 4 oz.
51452-001-162019-10-29C16284748780-1960f7f55-c87b-8e05-e053-dbdaa90a074aCold Spot Point Relief Pain relieving Gel - 16 oz.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51452-001-00Cold SpotPoint Relief5 g in 1 BOTTLE, DISPENSINGGEL54
51452-001-04Cold SpotPoint Relief120 mL in 1 TUBEGEL1203

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
MentholACTIVE INGREDIENTL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
MentholACTIVE MOIETYL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
MENTHOLACTIVE MOIETYL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
alcoholINACTIVE INGREDIENT3K9958V90MCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
ARNICA CORDIFOLIA FLOWERINACTIVE INGREDIENTJCG1OSZ7A8COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
ARNICA CORDIFOLIA FLOWERINACTIVE INGREDIENTJCG1OSZ7A8COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
CARBOMER 1342INACTIVE INGREDIENT809Y72KV36COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5ZCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
Citric AcidINACTIVE INGREDIENT2968PHW8QPCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FTCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FTCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
Eucalyptus Globulus LEAFINACTIVE INGREDIENTS546YLW6E6COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
Glucosamine sulfateINACTIVE INGREDIENT1FW7WLR731COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
Ilex Paraguariensis LeaFINACTIVE INGREDIENT1Q953B4O4FCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
Ilex Paraguariensis LeafINACTIVE INGREDIENT1Q953B4O4FCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
Peppermint OilINACTIVE INGREDIENTAV092KU4JHCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
Peppermint OilINACTIVE INGREDIENTAV092KU4JHCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
WATERINACTIVE INGREDIENT059QF0KO0RCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
waterINACTIVE INGREDIENT059QF0KO0RCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4
MENTHOLACTIVE INGREDIENTL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
MENTHOLACTIVE MOIETYL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
ARNICA CORDIFOLIA FLOWERINACTIVE INGREDIENTJCG1OSZ7A8COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
CARBOMER 1342INACTIVE INGREDIENT809Y72KV36COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3
WATERINACTIVE INGREDIENT059QF0KO0RCOLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51452-001COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]4Legacy NDC, 1 package rows20101130_823ccf6b-f494-4ddb-9547-431c2367d65f.zip
51452-001COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [FABRICATION ENTERPRISES]3Legacy NDC, 1 package rows20101130_7013706a-3afe-430f-a510-c7735a922150.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235996ColdSpot POINT RELIEF 12 % / 4 % Topical GelPSN823ccf6b-f494-4ddb-9547-431c2367d65f4
1045442menthol 12 % / methyl salicylate 4 % Topical GelPSN823ccf6b-f494-4ddb-9547-431c2367d65f4
1235996menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel [Cold Spot with Methyl Salicylate]SBD823ccf6b-f494-4ddb-9547-431c2367d65f4
1045442menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical GelSCD823ccf6b-f494-4ddb-9547-431c2367d65f4
1235996Cold Spot Point Relief with Methyl Salicylate (menthol 12 % / methyl salicylate 4 % ) Topical GelSY823ccf6b-f494-4ddb-9547-431c2367d65f4
1235996Cold Spot with Methyl Salicylate (menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG) Topical GelSY823ccf6b-f494-4ddb-9547-431c2367d65f4
1045442menthol 12 % / methyl salicylate 4 % Topical GelSY823ccf6b-f494-4ddb-9547-431c2367d65f4
1235996ColdSpot POINT RELIEF 12 % / 4 % Topical GelPSN7013706a-3afe-430f-a510-c7735a9221503
1045442menthol 12 % / methyl salicylate 4 % Topical GelPSN7013706a-3afe-430f-a510-c7735a9221503
1235996menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel [Cold Spot with Methyl Salicylate]SBD7013706a-3afe-430f-a510-c7735a9221503
1045442menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical GelSCD7013706a-3afe-430f-a510-c7735a9221503
1235996Cold Spot Point Relief with Methyl Salicylate (menthol 12 % / methyl salicylate 4 % ) Topical GelSY7013706a-3afe-430f-a510-c7735a9221503
1235996Cold Spot with Methyl Salicylate (menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG) Topical GelSY7013706a-3afe-430f-a510-c7735a9221503
1045442menthol 12 % / methyl salicylate 4 % Topical GelSY7013706a-3afe-430f-a510-c7735a9221503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51452-001-00514520001005 g in 1 BOTTLE, DISPENSING5 gHistorical
51452-001-0451452000104120 mL in 1 TUBE120 mlHistorical