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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage83295-400083295-4000-5DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2667457Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
074b53d0-d9d8-8d24-e063-6294a90a9fdaAvailable on FDA.report

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

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
TrubrexaLIDOCAINE AND CAPSAICINStrand Health Group074b53d0-d9d8-8d24-e063-6294a90a9fda2025-12-18WarningsExact identifier
ndc (product): 83295-4000

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 pouch2023-10-03NoNoCurrent
83295-4000-4832954000044 PATCH in 1 POUCH (83295-4000-4) / 2.7 g in 1 PATCH4 patch2023-10-03NoNoCurrent
83295-4000-5832954000054 in 1 POUCHHistorical