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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043399Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dce9db37-cd07-44d8-8881-f63a2191964fAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Capsaicin Pain ReliefCAPSAICINKareway Product, Inc.dce9db37-cd07-44d8-8881-f63a2191964f2018-06-07WarningsExact identifier
ndc (product): 67510-0303

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