Careone Extra Strength Cold and Hot

Product NDC
41520-871
11-digit product format
415200871
Labeler code
41520
Product ID
41520-871_97686ef1-f3f9-cf31-e053-2995a90ae3e8
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
American Sales Company
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-16
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
0 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41520-871IInactivated by FDA2026-10-15
excluded packagepackage41520-87141520-871-05IInactivated by FDA2026-10-15

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 1 · 36 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 packagepackage41520-871-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41520-871-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41520-871-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41520-871-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41520-871-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41520-871-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41520-871-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41520-871-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41520-871-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41520-871-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41520-871-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41520-871-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage41520-871-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage41520-871-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage41520-871-051332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage41520-871-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage41520-871-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage41520-871-05bd6a592717d7…303034d00443…

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-871-052022-01-28C16284748780-1d6a99b39-6b23-a426-e053-dadaa90af4c21b66857c-38fb-49b5-a438-533c02aba4cc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-871-05Careone Extra Strength Cold and Hot5 in 1 CARTONPATCH53
41520-871-05Careone Extra Strength Cold and Hot1 in 1 PATCHPATCH13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
MENTHOLACTIVE MOIETYL7T10EIP3ACAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0CAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
GELATININACTIVE INGREDIENT2G86QN327LCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
KAOLININACTIVE INGREDIENT24H4NWX5COCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-871CAREONE EXTRA STRENGTH COLD AND HOT (MENTHOL) PATCH [AMERICAN SALES COMPANY]3Legacy NDC, 2 package rows20191116_1b66857c-38fb-49b5-a438-533c02aba4cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN1b66857c-38fb-49b5-a438-533c02aba4cc3
420222menthol 0.05 MG/MG Medicated PatchSCD1b66857c-38fb-49b5-a438-533c02aba4cc3
420222menthol 5 % Medicated PatchSY1b66857c-38fb-49b5-a438-533c02aba4cc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-871-05415200871055 PATCH in 1 CARTON (41520-871-05) > 1 PATCH in 1 PATCH5 patch2017-05-100000-00-00NoNoCurrent