Dendracin Neurodendraxcin®, Topical Pain Relief Lotion

Manufacturer
Unit Dose Services
Effective date
2018-07-02
Label type
HUMAN OTC DRUG LABEL
Version
25
Source
full-release
Hydrated at
2026-05-31 22:56:32

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 swallowed, call poison control. 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.

Warnings:

WARNINGS SECTION

For external use only. Do not use in eyes, mouth, on mucous membranes, or genitals. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products.

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 swallowed, call poison control. 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

Water, benzocaine, glyceryl stearate, PEG 100 stearate, stearic acid, cetyl alcohol, propylene glycol, dimethyl sulfoxide, triethanolamine, poloxamer 407, aloe barbadensis gel, borage oil, ammonium acryloyldimethyltaurate, zingiber officinale root extract, methylparaben, propylparaben, soya lecithin, DMDM hydantoin, sodium stearoyl glutamate.

SPL UNCLASSIFIED SECTION

Manufactured for Physicians' Science and Nature, Inc.

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

Made in the USA

Patent Pending

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50436-0165

NDC: 50436-0165-1 120 mL in a BOTTLE

DENDRACIN TOPICAL PAIN RELIEF

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116967capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % Topical LotionPSN25
1116971DENDRACIN Neurodendraxcin 0.025 % / 10 % / 30 % Topical LotionPSN25
1116971capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical Lotion [Dendracin Neurodendraxcin]SBD25
1116967capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical LotionSCD25
1116967capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % Topical LotionSY25
1116971Dendracin Neurodendraxcin (capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % ) Topical LotionSY25

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0165-12020-01-31C16284748780-19d75b9d0-62dd-f424-e053-dadaa90a57ceDendracin Neurodendraxcin®, Topical Pain Relief Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0165-1Dendracin Neurodendraxcin120 mL in 1 BOTTLELOTION12025

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0165DENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [UNIT DOSE SERVICES]25Legacy NDC, 1 package rows20180808_b36c7977-557d-4ab4-bc4a-35875f1848e6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0165-1ML - Milliliter50436-0165be4481ce-4c12-4c8b-989c-abf979f115b612012-07-24
27495-014-02ML - Milliliter27495-014c650ba41-26d0-4a0c-8aa5-e506bad4bc3812012-07-24
27495-014-04ML - Milliliter27495-01457cee12b-4811-4fbd-9fa3-e71c5e5af99a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM9
MENTHOLACTIVE INGREDIENTL7T10EIP3A9
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y9
CAPSAICINACTIVE MOIETYS07O44R1ZM9
MENTHOLACTIVE MOIETYL7T10EIP3A9
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ9
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X9
AMMONIO METHACRYLATE COPOLYMER TYPE AINACTIVE INGREDIENT8GQS4E66YY9
BENZOCAINEINACTIVE INGREDIENTU3RSY48JW59
BORAGE OILINACTIVE INGREDIENTF8XAG1755S9
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN9
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698H9
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW9
GINGERINACTIVE INGREDIENTC5529G5JPQ9
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE49
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM629
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T9
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R9
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M29
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V39
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH9
SODIUM STEAROYL GLUTAMATEINACTIVE INGREDIENT65A9F4P0249
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP9
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK9
WATERINACTIVE INGREDIENT059QF0KO0R9

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
50436-016550436-0165-1
27495-014

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 25 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GINGERGINGERC5529G5JPQELIXIR / ORAL10 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62POWDER, FOR SUSPENSION / ORAL39 mgExact identifier — unii candidate
7 equally ranked IID candidates
BENZOCAINEBENZOCAINEU3RSY48JW5OINTMENT / TOPICAL1 %w/wExact identifier — unii+route
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62AEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
AMMONIO METHACRYLATE COPOLYMER TYPE AAMMONIO METHACRYLATE COPOLYMER TYPE A8GQS4E66YYCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
4 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
TROLAMINETROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii+route+dosage form
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
AMMONIO METHACRYLATE COPOLYMER TYPE AAMMONIO METHACRYLATE COPOLYMER TYPE A8GQS4E66YYPOWDER, FOR SUSPENSION / ORAL161 mg/5mlExact identifier — unii candidate
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route+dosage form
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii candidate
7 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
POLOXAMER 407POLOXAMER 407TUF2IVW3M2LOTION / TOPICAL71 mgExact identifier — unii+route+dosage form
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
AMMONIO METHACRYLATE COPOLYMER TYPE AAMMONIO METHACRYLATE COPOLYMER TYPE A8GQS4E66YYTABLET, FILM COATED, EXTENDED RELEASE / ORAL25 mgExact identifier — unii candidate
4 equally ranked IID candidates
AMMONIO METHACRYLATE COPOLYMER TYPE AAMMONIO METHACRYLATE COPOLYMER TYPE A8GQS4E66YYTABLET, EXTENDED RELEASE / ORAL361 mgExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HLOTION / TOPICAL45.5 %w/wExact identifier — unii+route+dosage form
GINGERGINGERC5529G5JPQSYRUP / ORAL0.05 ml/5mlExact identifier — unii candidate
2 equally ranked IID candidates

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
9c3eaf3f-9fca-43ad-9f61-158e1826cbe0b36c7977-557d-4ab4-bc4a-35875f1848e62018-07-02WarningsExact identifier
spl id: 9c3eaf3f-9fca-43ad-9f61-158e1826cbe0
spl set id: b36c7977-557d-4ab4-bc4a-35875f1848e6

Reported adverse events (FAERS/openFDA)#

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