PT Elite Premium Pain Relief

Product NDC
85808-615
11-digit product format
858080615
Labeler code
85808
Product ID
85808-615_3a81868c-3aa7-5e51-e063-6294a90a2952
Type
HUMAN OTC DRUG
Nonproprietary name
CAPSAICIN, MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
PT ELITE PRODUCTS LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-09
Substance
CAPSAICIN; MENTHOL
Active strength
.35; 40 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PT Elite Premium Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.35 mg/mL
MENTHOL40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, L7T10EIP3A
Rxcui1865193

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
85808-615-00PT Elite Premium Pain Relief100 mL in 1 TUBECREAM1002
85808-615-00PT Elite Premium Pain Relief1 in 1 BOXCREAM12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1865193capsaicin 0.035 % / menthol 4 % Topical CreamPSNad251821-4c58-425d-bdcb-8dd9bd41b7132
1865193capsaicin 0.35 MG/ML / menthol 40 MG/ML Topical CreamSCDad251821-4c58-425d-bdcb-8dd9bd41b7132
1865193capsaicin 0.035 % / menthol 4 % Topical CreamSYad251821-4c58-425d-bdcb-8dd9bd41b7132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85808-615-00858080615001 TUBE in 1 BOX (85808-615-00) / 100 mL in 1 TUBE1 tube2025-05-09NoNoHistorical