FDA.reportPublic FDA data

Dendracin Neurodendraxcin Topical Pain Relief Lotion

Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:41:50

Label at a glance#

ProductDendracin Neurodendraxcin
Active ingredientMETHYL SALICYLATE, MENTHOL, CAPSAICIN
Label structure11 sections

Indications and uses

For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Dosage and administration

Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If placed into eyes, rinse with cold water and call a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 30%
Menthol 10%
Capsaicin 0.025%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

USES:

INDICATIONS & USAGE SECTION

For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Keep away from children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

WARNINGS:

WARNINGS SECTION

For external use only. Do not use in eyes, mouth, on mucous membranes, or genitals. Do not allow treated skin to contact infants or pets. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products. May stain furniture, clothing or bedding.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If placed into eyes, rinse with cold water and call a doctor.

Do Not Use:

OTC - DO NOT USE SECTION

On cuts or infected skin, on children less than 12 years old, in large amounts, especially over raw or blistered skin, if allergic to any ingredients, PABA, aspirin products, or sulfa. Store below 90°F/32°C.

Stop Use and Ask a Physician:

OTC - STOP USE SECTION

For severe undiagnosed pain. If pain worsens or persist for more than 7 days. If pain clears up and then recurs in a few days. If itching or rash occurs.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Benzocaine, Borago Officinalis Seed Oil (Borage Oil), Cetyl Alcohol, Dimethyl Sulfoxide, DMDM Hydantoin, Glyceryl Stearate, Methylparaben, PEG 100 Stearate, Poloxamer 407, Propylene Glycol, Propylparaben, Lecithin (Soy), Stearic Acid, Sodium Stearoyl Glucamate, Triethanolamine, Water, Officinale Root Extract.

SPL UNCLASSIFIED SECTION

Manufactured for Physician’s Science and Nature Inc.

220 Newport Center Drive 11-634, Newport Beach, CA 92660

Distributed by:

Advanced Rx of Tennessee, LLC

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dendracin Neurodendraxcin Lotion #120Dendracin Neurodendraxcin Lotion #120

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116967capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % Topical LotionPSN1
1116971DENDRACIN Neurodendraxcin 0.025 % / 10 % / 30 % Topical LotionPSN1
1116971capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical Lotion [Dendracin Neurodendraxcin]SBD1
1116967capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical LotionSCD1
1116967capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % Topical LotionSY1
1116971Dendracin Neurodendraxcin (capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % ) Topical LotionSY1

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 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

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
27495-014-02ML - Milliliter27495-014c650ba41-26d0-4a0c-8aa5-e506bad4bc3812012-07-24
27495-014-04ML - Milliliter27495-01457cee12b-4811-4fbd-9fa3-e71c5e5af99a12012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80425-045880425-0458-1
27495-014

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
POLOXAMER 407TUF2IVW3M2IACT
ALOE VERA LEAFZY81Z83H0XIACT
BORAGE SEED OILF8XAG1755SIACT
AMMONIO METHACRYLATE COPOLYMER TYPE A8GQS4E66YYIACT
GINGERC5529G5JPQIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DMDM HYDANTOINBYR0546TOWIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
TROLAMINE9O3K93S3TKIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
CAPSAICINS07O44R1ZMACTIB

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINPhysicians Science & Nature Inc.05742cd5-ece2-4007-bdf0-46b76d23df742025-11-10WarningsExact identifier
ndc (product): 27495-014
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
spl id: 28891eff-23c5-1409-e063-6394a90ad19d
spl set id: 2889181b-12fc-245b-e063-6394a90a2c4c

Reported adverse events (FAERS/openFDA)#

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