FDA.reportPublic FDA data

Neurodexx

Manufacturer
Rely Wellness | Westwood Laboratories Inc.
Effective date
2023-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:16

Label at a glance#

ProductNeurodexx
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.

Keep Out Of Reach Of 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 or 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 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/VP Copolymer, Zingiber Officinale Root Extract, Methylparaben, Propylparaben, Soy Lecithin, DMDM Hydantoin, Sodium Stearoyl Glutamate

SPL UNCLASSIFIED SECTION

Manufactured for: Rely Wellness
5777 W. Century Blvd, #1100 Unit #371, Los Angeles, CA 90045

Neurodexx™ Pain Relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hot Deep

Penetrating MAXIMUM STRENGTH

Topical Pain Relief Lotion

Provides Fast Temporary Relief from:

  • Arthritis pain
  • Muscular & Rheumetric pain
  • Joint pain & stifness


Doctor Recommended

  • Doctor Formulated
  • Dermatologically Tested Hypoallergenic

120 ml (4 fl oz)
NDC 81649-030-04

BottleBottle

0.25gm (0.25 ml)

NDC 81649-030-25

SampleSample

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116967capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % Topical LotionPSN2
1116967capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical LotionSCD2
1116967capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % Topical LotionSY2

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
81649-030-042025-01-30C16284748780-12cef2736-9708-d83d-e063-dadaa90ab31fNeurodexx™ Pain Relief
81649-030-252025-01-30C16284748780-12cef2736-9708-d83d-e063-dadaa90ab31fNeurodexx™ Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81649-030-04Neurodexx120 mL in 1 BOTTLELOTION1202
81649-030-25Neurodexx0.25 mL in 1 PACKETLOTION0.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81649-030NEURODEXX (PAIN RELIEF) LOTION [RELY WELLNESS]2Legacy NDC, 2 package rows20230117_c14e75d4-12ca-7527-e053-2995a90a0e16.zip

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
81649-03081649-030-25, 81649-030-04

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f268083a-cd6a-5b85-e053-2a95a90aae67c14e75d4-12ca-7527-e053-2995a90a0e162023-01-16WarningsExact identifier
spl id: f268083a-cd6a-5b85-e053-2a95a90aae67
spl set id: c14e75d4-12ca-7527-e053-2995a90a0e16

Reported adverse events (FAERS/openFDA)#

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