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 Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM
Rxcui2702859

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

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 patch2025-06-01NoNoHistorical