FDA.reportPublic FDA data

Capsaicin 0.035 Percent

Product NDC
50488-2035
11-digit product format
504882035
Labeler code
50488
Product ID
50488-2035_d6e671e2-8225-4fd9-a19d-f058ee174469
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
2025-06-01
Substance
CAPSAICIN
Active strength
.035 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 0.035 Percent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.035 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
2702859Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
597e0d44-21f8-4f98-b932-70345462f359Available 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
50488-2035-1Capsaicin 0.035 Percent100 g in 1 PATCHPATCH1003
50488-2035-1Capsaicin 0.035 Percent10 in 1 CARTONPATCH103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-2035-1EA - Each50488-2035b7bf44ec-8128-4f11-9a1c-ac9085800bb212025-08-11

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 0.035 PercentCAPSAICINAlexso, Inc597e0d44-21f8-4f98-b932-70345462f3592026-03-19WarningsExact identifier
ndc (product): 50488-2035

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2702859capsaicin 0.035 % Medicated PatchPSN597e0d44-21f8-4f98-b932-70345462f3593
2702859capsaicin 0.00035 MG/MG Medicated PatchSCD597e0d44-21f8-4f98-b932-70345462f3593
2702859capsaicin 0.035 % Medicated PatchSY597e0d44-21f8-4f98-b932-70345462f3593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50488-2035-15048820350110 PATCH in 1 CARTON (50488-2035-1) / 100 g in 1 PATCH10 patch2025-06-01NoNoCurrent