FDA.reportPublic FDA data

Trubrexa

Product NDC
83295-4000
11-digit product format
832954000
Labeler code
83295
Product ID
83295-4000_463f4eb6-9740-7c2e-e063-6394a90a2a56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine and capsaicin
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Strand Health Group
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
83295-4000-1Trubrexa8 in 1 BOXPATCH88
83295-4000-1Trubrexa4 in 1 POUCHPATCH48
83295-4000-4Trubrexa4 in 1 POUCHPATCH48
83295-4000-4Trubrexa2.7 g in 1 PATCHPATCH2.78
83295-4000-5Trubrexa4 in 1 POUCHPATCH48
83295-4000-5Trubrexa2.7 g in 1 PATCHPATCH2.78

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83295-4000-1EA - Each83295-40003511b98a-3fbf-41f0-911e-44084541485712023-12-05
83295-4000-4EA - Each83295-4000447b039e-5e22-4ae4-b3d2-78a83022407712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83295-4000TRUBREXA (LIDOCAINE AND CAPSAICIN) PATCH [STRAND HEALTH GROUP]7Current NDC, 6 package rows20240629_074b53d0-d9d8-8d24-e063-6294a90a9fda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667457lidocaine 4.75 % / capsaicin 0.025 % Medicated PatchPSN074b53d0-d9d8-8d24-e063-6294a90a9fda8
2667457capsaicin 0.00025 MG/MG / lidocaine 0.0475 MG/MG Medicated PatchSCD074b53d0-d9d8-8d24-e063-6294a90a9fda8
2667457capsaicin 0.025 % / lidocaine 4.75 % Medicated PatchSY074b53d0-d9d8-8d24-e063-6294a90a9fda8
2667457lidocaine 4.75 % / capsaicin 0.025 % Medicated PatchPSN0b28733a-1ac1-5e20-e063-6394a90a41f63
2667457lidocaine 4.75 % / capsaicin 0.025 % Medicated PatchPSN7a671ac6-5744-4e87-b1bd-434ca0a86e6d3
2667457capsaicin 0.00025 MG/MG / lidocaine 0.0475 MG/MG Medicated PatchSCD0b28733a-1ac1-5e20-e063-6394a90a41f63
2667457capsaicin 0.00025 MG/MG / lidocaine 0.0475 MG/MG Medicated PatchSCD7a671ac6-5744-4e87-b1bd-434ca0a86e6d3
2667457capsaicin 0.025 % / lidocaine 4.75 % Medicated PatchSY0b28733a-1ac1-5e20-e063-6394a90a41f63
2667457capsaicin 0.025 % / lidocaine 4.75 % Medicated PatchSY7a671ac6-5744-4e87-b1bd-434ca0a86e6d3
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
2667457lidocaine 4.75 % / capsaicin 0.025 % Medicated PatchPSN1367f190-670a-d2de-e063-6394a90abb131
2667457lidocaine 4.75 % / capsaicin 0.025 % Medicated PatchPSNdbdf1df3-7289-4165-8815-f664bef82c561
2667457capsaicin 0.00025 MG/MG / lidocaine 0.0475 MG/MG Medicated PatchSCD1367f190-670a-d2de-e063-6394a90abb131
2667457capsaicin 0.00025 MG/MG / lidocaine 0.0475 MG/MG Medicated PatchSCDdbdf1df3-7289-4165-8815-f664bef82c561
2667457capsaicin 0.025 % / lidocaine 4.75 % Medicated PatchSY1367f190-670a-d2de-e063-6394a90abb131
2667457capsaicin 0.025 % / lidocaine 4.75 % Medicated PatchSYdbdf1df3-7289-4165-8815-f664bef82c561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83295-4000-1832954000018 POUCH in 1 BOX (83295-4000-1) / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH8 pouch2023-10-03NoNoHistorical
83295-4000-4832954000044 PATCH in 1 POUCH (83295-4000-4) / 2.7 g in 1 PATCH4 patch2023-10-03NoNoHistorical
83295-4000-5832954000054 in 1 POUCHHistorical