FDA.reportPublic FDA data

Capsaicin

Product NDC
50488-2025
11-digit product format
504882025
Labeler code
50488
Product ID
50488-2025_5b1f8142-a34d-4331-8a79-edac1702414b
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
Alexso, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-08
Substance
CAPSAICIN
Active strength
.025 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Capsaicin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.025 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
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
030d67b2-d798-4134-bc96-69536ad46f2dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
50488-2025-1Capsaicin5 in 1 POUCHPATCH55
50488-2025-1Capsaicin2 in 1 BOXPATCH25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-2025-1EA - Each50488-20252e0a1745-4c06-4c66-8d9c-7f4f23c1771f12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-2025CAPSAICIN PATCH [ALEXSO, INC]4Current NDC, Legacy NDC, 2 package rows20241208_030d67b2-d798-4134-bc96-69536ad46f2d.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
CapsaicinCAPSAICINAlexso, Inc030d67b2-d798-4134-bc96-69536ad46f2d2026-03-19WarningsExact identifier
ndc (product): 50488-2025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSN030d67b2-d798-4134-bc96-69536ad46f2d5
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD030d67b2-d798-4134-bc96-69536ad46f2d5
1043399capsaicin 0.025 % Medicated PatchSY030d67b2-d798-4134-bc96-69536ad46f2d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50488-2025-1504882025012 POUCH in 1 BOX (50488-2025-1) / 5 PATCH in 1 POUCH / 100 g in 1 PATCH2 pouch2020-01-080000-00-00NoNoCurrent