FDA.reportPublic FDA data

Capsaicin 0.03% Patch

Product NDC
82461-418
11-digit product format
824610418
Labeler code
82461
Product ID
82461-418_1f68a068-2ae3-476e-92e3-4b03c0f0762f
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin 0.03%
Dosage form
PATCH
Route
TOPICAL
Labeler
Medcore LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
Substance
CAPSAICIN
Active strength
.03 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Capsaicin 0.03% Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.03 g/100g

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
2727393Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046c073-c270-4be3-89f2-e8c91f1af97bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82461-418-10Capsaicin 0.03% Patch100 g in 1 PATCHPATCH1001
82461-418-10Capsaicin 0.03% Patch10 in 1 CARTONPATCH101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82461-418-10EA - Each82461-4189c1f761a-2e13-42f3-bbc6-931103a8c41d12026-01-08

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 0.03% PatchCAPSAICIN 0.03%Medcore LLC1046c073-c270-4be3-89f2-e8c91f1af97b2025-11-04WarningsExact identifier
ndc (product): 82461-418

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2727393capsaicin 0.03 % Medicated PatchPSN1046c073-c270-4be3-89f2-e8c91f1af97b1
2727393capsaicin 0.0003 MG/MG Medicated PatchSCD1046c073-c270-4be3-89f2-e8c91f1af97b1
2727393capsaicin 0.03 % Medicated PatchSY1046c073-c270-4be3-89f2-e8c91f1af97b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82461-418-108246104181010 PATCH in 1 CARTON (82461-418-10) / 100 g in 1 PATCH10 patch2025-11-01NoNoCurrent