FDA.reportPublic FDA data

Trubrexa

Product NDC
68788-8599
Requested package NDC
68788-8599-3
11-digit product format
687888599
Labeler code
68788
Product ID
68788-8599_fa7eb608-492f-48e5-8f08-71f32f723392
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine and capsaicin
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Preferred Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-03-15
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
7a671ac6-5744-4e87-b1bd-434ca0a86e6dAvailable 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
68788-8599-3Trubrexa8 in 1 BOXPATCH83
68788-8599-3Trubrexa4 in 1 POUCHPATCH43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8599-3EA - Each68788-8599bc87deff-5304-4f6c-8020-450b5ba7512e12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8599TRUBREXA (LIDOCAINE AND CAPSAICIN) PATCH [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20241110_7a671ac6-5744-4e87-b1bd-434ca0a86e6d.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 CAPSAICINPreferred Pharmaceuticals Inc.7a671ac6-5744-4e87-b1bd-434ca0a86e6d2025-10-02WarningsExact identifier
ndc (package): 68788-8599-3
ndc (product): 68788-8599
ndc11 (package): 68788859903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667457lidocaine 4.75 % / capsaicin 0.025 % Medicated PatchPSN7a671ac6-5744-4e87-b1bd-434ca0a86e6d3
2667457capsaicin 0.00025 MG/MG / lidocaine 0.0475 MG/MG Medicated PatchSCD7a671ac6-5744-4e87-b1bd-434ca0a86e6d3
2667457capsaicin 0.025 % / lidocaine 4.75 % Medicated PatchSY7a671ac6-5744-4e87-b1bd-434ca0a86e6d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8599-3687888599038 POUCH in 1 BOX (68788-8599-3) / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH8 pouch2024-03-15NoNoCurrent