Cold Spot

Product NDC
51452-003
11-digit product format
514520003
Labeler code
51452
Product ID
51452-003_fbe6ecf2-e153-4ebb-a3bc-7d259cc9528d
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
fabrication enterprises
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-08-24
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
48 mL/480mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51452-003IInactivated by FDA2026-10-12
excluded productproduct51452-003IInactivated by FDA2026-10-12
excluded productproduct51452-003IInactivated by FDA2026-10-12
excluded packagepackage51452-00351452-003-04IInactivated by FDA2026-10-12
excluded packagepackage51452-00351452-003-02IInactivated by FDA2026-10-12
excluded packagepackage51452-00351452-003-16IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 3 · 132 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51452-003-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51452-003-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51452-003-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51452-003-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51452-003-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51452-003-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51452-003-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51452-003-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51452-003-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51452-003-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51452-003-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51452-003-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51452-003-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51452-003-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51452-003-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51452-003-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51452-003-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51452-003-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51452-003-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51452-003-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51452-003-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51452-003-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51452-003-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51452-003-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51452-003-160efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51452-003-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51452-003-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51452-003-16ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51452-003-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51452-003-04ad56d346431e…cc804d4bbf1e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51452-003-02Cold SpotPoint Relief60 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY602
51452-003-04Cold SpotPoint Relief120 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY1202
51452-003-16Cold SpotPoint Relief480 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY4802

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
MentholACTIVE INGREDIENTL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
MentholACTIVE INGREDIENTL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
MentholACTIVE MOIETYL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
MentholACTIVE MOIETYL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
MentholACTIVE MOIETYL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
alcoholINACTIVE INGREDIENT3K9958V90MCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
alcoholINACTIVE INGREDIENT3K9958V90MCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
alcoholINACTIVE INGREDIENT3K9958V90MCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
ARNICA CORDIFOLIA FLOWERINACTIVE INGREDIENTJCG1OSZ7A8COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
ARNICA CORDIFOLIA FLOWERINACTIVE INGREDIENTJCG1OSZ7A8COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
ARNICA CORDIFOLIA FLOWERINACTIVE INGREDIENTJCG1OSZ7A8COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5ZCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5ZCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5ZCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Citric AcidINACTIVE INGREDIENT2968PHW8QPCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Citric AcidINACTIVE INGREDIENT2968PHW8QPCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Citric AcidINACTIVE INGREDIENT2968PHW8QPCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FTCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FTCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FTCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Glucosamine sulfateINACTIVE INGREDIENT1FW7WLR731COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Glucosamine sulfateINACTIVE INGREDIENT1FW7WLR731COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Glucosamine sulfateINACTIVE INGREDIENT1FW7WLR731COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Ilex Paraguariensis LeafINACTIVE INGREDIENT1Q953B4O4FCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Peppermint OilINACTIVE INGREDIENTAV092KU4JHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Peppermint OilINACTIVE INGREDIENTAV092KU4JHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
Peppermint OilINACTIVE INGREDIENTAV092KU4JHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
waterINACTIVE INGREDIENT059QF0KO0RCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
waterINACTIVE INGREDIENT059QF0KO0RCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2
waterINACTIVE INGREDIENT059QF0KO0RCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51452-003COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2Legacy NDC, 1 package rows20101118_a52ffd24-cdb4-49d1-b663-244df9b65488.zip
51452-003COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2Legacy NDC, 1 package rows20101206_14dd9255-214d-4903-b441-6b4a486a9f36.zip
51452-003COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [FABRICATION ENTERPRISES]2Legacy NDC, 1 package rows20101206_7f4c4adb-9318-48ee-9174-de8468e89bbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043283ColdSpot POINT RELIEF 10 % Topical SprayPSN14dd9255-214d-4903-b441-6b4a486a9f362
1043283ColdSpot POINT RELIEF 10 % Topical SprayPSNa52ffd24-cdb4-49d1-b663-244df9b654882
1043283ColdSpot POINT RELIEF 10 % Topical SprayPSN7f4c4adb-9318-48ee-9174-de8468e89bbc2
667889menthol 10 % Topical SprayPSN14dd9255-214d-4903-b441-6b4a486a9f362
667889menthol 10 % Topical SprayPSNa52ffd24-cdb4-49d1-b663-244df9b654882
667889menthol 10 % Topical SprayPSN7f4c4adb-9318-48ee-9174-de8468e89bbc2
1043283menthol 100 MG/ML Topical Spray [Cold Spot]SBDa52ffd24-cdb4-49d1-b663-244df9b654882
1043283menthol 100 MG/ML Topical Spray [Cold Spot]SBD14dd9255-214d-4903-b441-6b4a486a9f362
1043283menthol 100 MG/ML Topical Spray [Cold Spot]SBD7f4c4adb-9318-48ee-9174-de8468e89bbc2
667889menthol 100 MG/ML Topical SpraySCDa52ffd24-cdb4-49d1-b663-244df9b654882
667889menthol 100 MG/ML Topical SpraySCD7f4c4adb-9318-48ee-9174-de8468e89bbc2
667889menthol 100 MG/ML Topical SpraySCD14dd9255-214d-4903-b441-6b4a486a9f362
1043283Cold Spot 0.1 ML/ML Topical SpraySY7f4c4adb-9318-48ee-9174-de8468e89bbc2
1043283Cold Spot 0.1 ML/ML Topical SpraySY14dd9255-214d-4903-b441-6b4a486a9f362
1043283Cold Spot 0.1 ML/ML Topical SpraySYa52ffd24-cdb4-49d1-b663-244df9b654882
1043283Cold Spot Point Relief 10 % Topical SpraySY7f4c4adb-9318-48ee-9174-de8468e89bbc2
1043283Cold Spot Point Relief 10 % Topical SpraySY14dd9255-214d-4903-b441-6b4a486a9f362
1043283Cold Spot Point Relief 10 % Topical SpraySYa52ffd24-cdb4-49d1-b663-244df9b654882
667889menthol 10 % Topical SpraySY7f4c4adb-9318-48ee-9174-de8468e89bbc2
667889menthol 10 % Topical SpraySYa52ffd24-cdb4-49d1-b663-244df9b654882
667889menthol 10 % Topical SpraySY14dd9255-214d-4903-b441-6b4a486a9f362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51452-003-025145200030260 mL in 1 BOTTLE, SPRAY60 mlHistorical
51452-003-0451452000304120 mL in 1 BOTTLE, SPRAY120 mlHistorical
51452-003-1651452000316480 mL in 1 BOTTLE, SPRAY480 mlHistorical