FDA.reportPublic FDA data

Trubrexa

Product NDC
85509-4000
11-digit product format
855094000
Labeler code
85509
Product ID
85509-4000_415af5fd-7cb1-a160-e063-6294a90ad15b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine and capsaicin
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
PHOENIX RX LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-03
Substance
CAPSAICIN; LIDOCAINE
Active strength
.00025; .0475 g/g; g/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trubrexa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.00025 g/g
LIDOCAINE.0475 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, 98PI200987
Rxcui2667457

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-4000-3Trubrexa4 in 1 POUCHPATCH42
85509-4000-3Trubrexa8 in 1 BOXPATCH82

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-4000-3EA - Each85509-4000b337c920-6d4c-4ae7-9260-7efb08bdff5312025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667457lidocaine 4.75 % / capsaicin 0.025 % Medicated PatchPSN3a6500e6-3820-392f-e063-6294a90a769e2
2667457capsaicin 0.00025 MG/MG / lidocaine 0.0475 MG/MG Medicated PatchSCD3a6500e6-3820-392f-e063-6294a90a769e2
2667457capsaicin 0.025 % / lidocaine 4.75 % Medicated PatchSY3a6500e6-3820-392f-e063-6294a90a769e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85509-4000-3855094000038 POUCH in 1 BOX (85509-4000-3) / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH8 pouch2025-07-20NoNoHistorical