Cold Spot

Product NDC
65121-003
11-digit product format
651210003
Labeler code
65121
Product ID
65121-003_d82d99d9-f506-4013-a0b5-975d6f3fd9d4
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Pure Source
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 productproduct65121-003IInactivated by FDA2026-10-16
excluded productproduct65121-003IInactivated by FDA2026-10-16
excluded productproduct65121-003IInactivated by FDA2026-10-16
excluded packagepackage65121-00365121-003-04IInactivated by FDA2026-10-16
excluded packagepackage65121-00365121-003-02IInactivated by FDA2026-10-16
excluded packagepackage65121-00365121-003-16IInactivated by FDA2026-10-16

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 packagepackage65121-003-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65121-003-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65121-003-16d630ba8d3edf…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 packagepackage65121-003-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65121-003-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65121-003-16f5e01cc5f278…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 packagepackage65121-003-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65121-003-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65121-003-162ef7874e63bc…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 packagepackage65121-003-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65121-003-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65121-003-16a1b67e2a42f9…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 packagepackage65121-003-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65121-003-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65121-003-16cfe11265f3b6…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 packagepackage65121-003-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65121-003-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65121-003-16cdf11ea48f46…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 packagepackage65121-003-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65121-003-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65121-003-16302b2466d912…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 packagepackage65121-003-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65121-003-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65121-003-16ed331223b511…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 packagepackage65121-003-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65121-003-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65121-003-160efc9e666f02…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 packagepackage65121-003-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65121-003-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65121-003-16ad56d346431e…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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65121-003-04Cold SpotPoint Relief120 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY1206
65121-003-02Cold SpotPoint Relief60 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY605
65121-003-16Cold SpotPoint Relief120 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY1203

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
MentholACTIVE MOIETYL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
alcoholINACTIVE INGREDIENT3K9958V90MCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
Arnica cordifolia flowerINACTIVE INGREDIENTJCG1OSZ7A8COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
Chondroitin sulfate (bovine)INACTIVE INGREDIENT6IC1M3OG5ZCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
Citric AcidINACTIVE INGREDIENT2968PHW8QPCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FTCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
Eucalyptus Globulus leafINACTIVE INGREDIENTS546YLW6E6COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
Glucosamine sulfateINACTIVE INGREDIENT1FW7WLR731COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
Peppermint OilINACTIVE INGREDIENTAV092KU4JHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
waterINACTIVE INGREDIENT059QF0KO0RCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6
MentholACTIVE INGREDIENTL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
MentholACTIVE MOIETYL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
alcoholINACTIVE INGREDIENT3K9958V90MCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
ARNICA CORDIFOLIA FLOWERINACTIVE INGREDIENTJCG1OSZ7A8COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5ZCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
Citric AcidINACTIVE INGREDIENT2968PHW8QPCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FTCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
Glucosamine sulfateINACTIVE INGREDIENT1FW7WLR731COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
Peppermint OilINACTIVE INGREDIENTAV092KU4JHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
waterINACTIVE INGREDIENT059QF0KO0RCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5
MentholACTIVE INGREDIENTL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
MentholACTIVE MOIETYL7T10EIP3ACOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
alcoholINACTIVE INGREDIENT3K9958V90MCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
ARNICA CORDIFOLIA FLOWERINACTIVE INGREDIENTJCG1OSZ7A8COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5ZCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
Citric AcidINACTIVE INGREDIENT2968PHW8QPCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
Dimethyl SulfoneINACTIVE INGREDIENT9H4PO4Z4FTCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
Glucosamine sulfateINACTIVE INGREDIENT1FW7WLR731COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
Ilex Paraguariensis LeafINACTIVE INGREDIENT1Q953B4O4FCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
Peppermint OilINACTIVE INGREDIENTAV092KU4JHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3
waterINACTIVE INGREDIENT059QF0KO0RCOLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65121-003COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]6Legacy NDC, 1 package rows20101112_2a86e0fc-a65a-4951-8b38-03636b83fff8.zip
65121-003COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]5Legacy NDC, 1 package rows20101009_ae5fc436-9a8b-44e3-8b7d-94fb5a80c084.zip
65121-003COLD SPOT POINT RELIEF (MENTHOL) AEROSOL, SPRAY [PURE SOURCE]3Legacy NDC, 1 package rows20101104_c2b74583-a179-4c89-b479-3867d00f3cd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043283ColdSpot POINT RELIEF 10 % Topical SprayPSN2a86e0fc-a65a-4951-8b38-03636b83fff86
667889menthol 10 % Topical SprayPSN2a86e0fc-a65a-4951-8b38-03636b83fff86
1043283menthol 100 MG/ML Topical Spray [Cold Spot]SBD2a86e0fc-a65a-4951-8b38-03636b83fff86
667889menthol 100 MG/ML Topical SpraySCD2a86e0fc-a65a-4951-8b38-03636b83fff86
1043283Cold Spot 0.1 ML/ML Topical SpraySY2a86e0fc-a65a-4951-8b38-03636b83fff86
1043283Cold Spot Point Relief 10 % Topical SpraySY2a86e0fc-a65a-4951-8b38-03636b83fff86
667889menthol 10 % Topical SpraySY2a86e0fc-a65a-4951-8b38-03636b83fff86
1043283ColdSpot POINT RELIEF 10 % Topical SprayPSNae5fc436-9a8b-44e3-8b7d-94fb5a80c0845
667889menthol 10 % Topical SprayPSNae5fc436-9a8b-44e3-8b7d-94fb5a80c0845
1043283menthol 100 MG/ML Topical Spray [Cold Spot]SBDae5fc436-9a8b-44e3-8b7d-94fb5a80c0845
667889menthol 100 MG/ML Topical SpraySCDae5fc436-9a8b-44e3-8b7d-94fb5a80c0845
1043283Cold Spot 0.1 ML/ML Topical SpraySYae5fc436-9a8b-44e3-8b7d-94fb5a80c0845
1043283Cold Spot Point Relief 10 % Topical SpraySYae5fc436-9a8b-44e3-8b7d-94fb5a80c0845
667889menthol 10 % Topical SpraySYae5fc436-9a8b-44e3-8b7d-94fb5a80c0845
1043283ColdSpot POINT RELIEF 10 % Topical SprayPSNc2b74583-a179-4c89-b479-3867d00f3cd13
667889menthol 10 % Topical SprayPSNc2b74583-a179-4c89-b479-3867d00f3cd13
1043283menthol 100 MG/ML Topical Spray [Cold Spot]SBDc2b74583-a179-4c89-b479-3867d00f3cd13
667889menthol 100 MG/ML Topical SpraySCDc2b74583-a179-4c89-b479-3867d00f3cd13
1043283Cold Spot 0.1 ML/ML Topical SpraySYc2b74583-a179-4c89-b479-3867d00f3cd13
1043283Cold Spot Point Relief 10 % Topical SpraySYc2b74583-a179-4c89-b479-3867d00f3cd13
667889menthol 10 % Topical SpraySYc2b74583-a179-4c89-b479-3867d00f3cd13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
65121-003-026512100030260 mL in 1 BOTTLE, SPRAY60 mlHistorical
65121-003-0465121000304120 mL in 1 BOTTLE, SPRAY120 mlHistorical
65121-003-1665121000316120 mL in 1 BOTTLE, SPRAY120 mlHistorical