FDA.reportPublic FDA data

Capsaicin Pain Relief

Product NDC
67510-0303
11-digit product format
675100303
Labeler code
67510
Product ID
67510-0303_6e120fc6-2435-8dae-e053-2a91aa0a8f89
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
Kareway Product, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-01-23
Substance
CAPSAICIN
Active strength
.702 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Capsaicin Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.702 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM
Rxcui1043399

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0303-1Capsaicin Pain Relief1 in 1 CARTONPATCH13
67510-0303-1Capsaicin Pain Relief1 in 1 POUCHPATCH13
67510-0303-2Capsaicin Pain Relief2 in 1 POUCHPATCH23

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMCAPSAICIN PAIN RELIEF (CAPSAICIN) PATCH [KAREWAY PRODUCT, INC.]1
CAPSAICINACTIVE MOIETYS07O44R1ZMCAPSAICIN PAIN RELIEF (CAPSAICIN) PATCH [KAREWAY PRODUCT, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCAPSAICIN PAIN RELIEF (CAPSAICIN) PATCH [KAREWAY PRODUCT, INC.]1
NATURAL LATEX RUBBERINACTIVE INGREDIENT2LQ0UUW8INCAPSAICIN PAIN RELIEF (CAPSAICIN) PATCH [KAREWAY PRODUCT, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPSAICIN PAIN RELIEF (CAPSAICIN) PATCH [KAREWAY PRODUCT, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCAPSAICIN PAIN RELIEF (CAPSAICIN) PATCH [KAREWAY PRODUCT, INC.]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZCAPSAICIN PAIN RELIEF (CAPSAICIN) PATCH [KAREWAY PRODUCT, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0303CAPSAICIN PAIN RELIEF (CAPSAICIN) PATCH [KAREWAY PRODUCT, INC.]3Current NDC, Legacy NDC, 3 package rows20180607_dce9db37-cd07-44d8-8881-f63a2191964f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSNdce9db37-cd07-44d8-8881-f63a2191964f3
1043399capsaicin 0.00025 MG/MG Medicated PatchSCDdce9db37-cd07-44d8-8881-f63a2191964f3
1043399capsaicin 0.025 % Medicated PatchSYdce9db37-cd07-44d8-8881-f63a2191964f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67510-0303-1675100303011 POUCH in 1 CARTON (67510-0303-1) / 1 PATCH in 1 POUCH1 pouch2012-01-230000-00-00NoNoCurrent
67510-0303-2675100303022 PATCH in 1 POUCH (67510-0303-2) 2 patch2018-05-180000-00-00NoNoCurrent