FDA.reportPublic FDA data

Trubrexa

Product NDC
76420-644
Requested package NDC
76420-644-32
11-digit product format
764200644
Labeler code
76420
Product ID
76420-644_0c5d5420-c6cf-0d61-e063-6394a90aea41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine and capsaicin
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Asclemed USA, Inc.
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

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
dbdf1df3-7289-4165-8815-f664bef82c56Available on FDA.report

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
76420-644-32Trubrexa8 in 1 BOXPATCH81
76420-644-32Trubrexa4 in 1 POUCHPATCH41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-644-32EA - Each76420-6448dd25317-1ab9-4c9a-9322-025bf8f4e3ff12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-644TRUBREXA (LIDOCAINE AND CAPSAICIN) PATCH [ASCLEMED USA, INC.]1Current NDC, 2 package rows20231214_dbdf1df3-7289-4165-8815-f664bef82c56.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 CAPSAICINAsclemed USA, Inc.dbdf1df3-7289-4165-8815-f664bef82c562023-12-12WarningsExact identifier
ndc (package): 76420-644-32
ndc (product): 76420-644
ndc11 (package): 76420064432

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667457lidocaine 4.75 % / capsaicin 0.025 % Medicated PatchPSNdbdf1df3-7289-4165-8815-f664bef82c561
2667457capsaicin 0.00025 MG/MG / lidocaine 0.0475 MG/MG Medicated PatchSCDdbdf1df3-7289-4165-8815-f664bef82c561
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
76420-644-32764200644328 POUCH in 1 BOX (76420-644-32) / 4 PATCH in 1 POUCH / 2.7 g in 1 PATCH8 pouch2023-12-13NoNoCurrent