FDA.reportPublic FDA data

Dendracin Neurodendraxcin

Product NDC
80425-0458
Requested package NDC
80425-0458-1
11-digit product format
804250458
Labeler code
80425
Product ID
80425-0458_28891eff-23c5-1409-e063-6394a90ad19d
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Menthol and Capsaicin
Dosage form
LOTION
Route
TOPICAL
Labeler
Advanced Rx of Tennessee, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-12-05
Substance
CAPSAICIN; MENTHOL; METHYL SALICYLATE
Active strength
.015; 6; 18 g/60mL; g/60mL; g/60mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE.015 g/60mL
MENTHOL6 g/60mL
CAPSAICIN18 g/60mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1116967Internal RxNorm lookup
1116971Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2889181b-12fc-245b-e063-6394a90a2c4cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0458-1Dendracin Neurodendraxcin120 mL in 1 BOTTLELOTION1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0458-1ML - Milliliter80425-04585cee2290-7b34-44b3-b436-0c2412f585a512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0458DENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 1 package rows20241212_2889181b-12fc-245b-e063-6394a90a2c4c.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
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINAdvanced Rx of Tennessee, LLC2889181b-12fc-245b-e063-6394a90a2c4c2024-12-05WarningsExact identifier
ndc (package): 80425-0458-1
ndc (product): 80425-0458
ndc11 (package): 80425045801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116967capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % Topical LotionPSN2889181b-12fc-245b-e063-6394a90a2c4c1
1116971DENDRACIN Neurodendraxcin 0.025 % / 10 % / 30 % Topical LotionPSN2889181b-12fc-245b-e063-6394a90a2c4c1
1116971capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical Lotion [Dendracin Neurodendraxcin]SBD2889181b-12fc-245b-e063-6394a90a2c4c1
1116967capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical LotionSCD2889181b-12fc-245b-e063-6394a90a2c4c1
1116967capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % Topical LotionSY2889181b-12fc-245b-e063-6394a90a2c4c1
1116971Dendracin Neurodendraxcin (capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % ) Topical LotionSY2889181b-12fc-245b-e063-6394a90a2c4c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0458-180425045801120 mL in 1 BOTTLE (80425-0458-1) 120 ml2024-12-05NoNoCurrent