FDA.reportPublic FDA data

Cold and Hot Pain Relief Sleeve

Product NDC
67510-0085
11-digit product format
675100085
Labeler code
67510
Product ID
67510-0085_ae81ade6-5e4b-bc6a-e053-2a95a90a8332
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Kareway Product, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-04-19
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
400 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-0085-42022-01-28C16284748780-19d75b9d0-a0f0-f424-e053-dadaa90a57cePure-Aid Cold & Hot Sleeve
67510-0085-42020-09-04C16284748780-19d75b9d0-a0f0-f424-e053-dadaa90a57cePure-Aid Cold & Hot Sleeve
67510-0085-42020-01-31C16284748780-19d75b9d0-a0f0-f424-e053-dadaa90a57cePure-Aid Cold & Hot Sleeve

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0085-4Cold and Hot Pain Relief Sleeve1 in 1 POUCHPATCH12
67510-0085-4Cold and Hot Pain Relief Sleeve1 in 1 BOXPATCH12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACOLD AND HOT PAIN RELIEF SLEEVE (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ACOLD AND HOT PAIN RELIEF SLEEVE (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD AND HOT PAIN RELIEF SLEEVE (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302COLD AND HOT PAIN RELIEF SLEEVE (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOLD AND HOT PAIN RELIEF SLEEVE (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOLD AND HOT PAIN RELIEF SLEEVE (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOLD AND HOT PAIN RELIEF SLEEVE (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLD AND HOT PAIN RELIEF SLEEVE (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0085COLD AND HOT PAIN RELIEF SLEEVE (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2Legacy NDC, 2 package rows20200905_1a11d455-c8e5-4ee7-8e0b-6c3eefc29c86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043743menthol 16 % Medicated PatchPSN1a11d455-c8e5-4ee7-8e0b-6c3eefc29c862
1043743menthol 0.16 MG/MG Medicated PatchSCD1a11d455-c8e5-4ee7-8e0b-6c3eefc29c862
1043743menthol 16 % Medicated PatchSY1a11d455-c8e5-4ee7-8e0b-6c3eefc29c862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67510-0085-4675100085041 POUCH in 1 BOX (67510-0085-4) > 1 PATCH in 1 POUCH1 pouch2012-04-190000-00-00NoNoCurrent