Triple Power

Product NDC
64058-341
11-digit product format
640580341
Labeler code
64058
Product ID
64058-341_496b8ced-0ca7-4589-aa44-f23b887fa812
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM and CAMPHOR (SYNTHETIC)
Dosage form
CREAM
Route
TOPICAL
Labeler
Concept Laboratories, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-06-25
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC)
Active strength
0 g/g; g/g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct64058-341IInactivated by FDA2026-10-12
excluded packagepackage64058-34164058-341-64IInactivated 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 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64058-341-64IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64058-341-64IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64058-341-64IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64058-341-64IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64058-341-64IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64058-341-64IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64058-341-64IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64058-341-64IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64058-341-64IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64058-341-64IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64058-341-64IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64058-341-64IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64058-341-64IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64058-341-64IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64058-341-64IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64058-341-64IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64058-341-64IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64058-341-64IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64058-341-64IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64058-341-64IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64058-341-64IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64058-341-64EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64058-341-642020-01-31C16284748780-19d75b9d0-45a9-f424-e053-dadaa90a57ceTriple Power Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64058-341-64Triple Power Pain Relief106 g in 1 BOTTLECREAM1061

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
MENTHOL, UNSPECIFIED FORMACTIVE INGREDIENTL7T10EIP3ATRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
MENTHOL, UNSPECIFIED FORMACTIVE MOIETYL7T10EIP3ATRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
ACAI OILINACTIVE INGREDIENTZ0W6766A2WTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
ETHYL MENTHANE CARBOXAMIDEINACTIVE INGREDIENT6S7S02945HTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
LAURYL LAURATEINACTIVE INGREDIENTGPW77G0937TRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
LINSEED OILINACTIVE INGREDIENT84XB4DV00WTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7ITRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
METHYL DIISOPROPYL PROPIONAMIDEINACTIVE INGREDIENT6QOP5A9489TRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
PPG-2 HYDROXYETHYL COCAMIDEINACTIVE INGREDIENT34N07GUJ3XTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM393TRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RTRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64058-341TRIPLE POWER PAIN RELIEF (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1Legacy NDC, 1 package rows20150701_4d044ecc-2e1f-4cc1-8202-8c65b563e7c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1150970camphor 6 % / menthol 12 % Topical CreamPSN4d044ecc-2e1f-4cc1-8202-8c65b563e7c51
1150970camphor 60 MG/ML / menthol 120 MG/ML Topical CreamSCD4d044ecc-2e1f-4cc1-8202-8c65b563e7c51
1150970camphor 6 % / menthol 12 % Topical CreamSY4d044ecc-2e1f-4cc1-8202-8c65b563e7c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64058-341-6464058034164106 g in 1 BOTTLE106 gHistorical