FDA.reportPublic FDA data

Nyloxin

Manufacturer
Nutra Pharma Corporation
Effective date
2025-10-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:37:13

Label at a glance#

ProductNyloxin
Active ingredientNAJA NAJA VENOM
Label structure10 sections

Indications and uses

Temporarily relieves joint pain associated with overuse and pain associated with arthritis.

Dosage and administration

Remove protective wrapping. Liberally apply gel to the affected area and rub into joints. Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort. Allow several days for drug to take maximum effect.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Analgesic Topical Gel

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Asian Cobra Venom 4x

Purpose

OTC - PURPOSE SECTION

Analgesic*

*Claim based on traditional Homeopathic practices not accepted medical evidence. Not FDA approved.

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves joint pain associated with overuse and pain associated with arthritis.

Warnings:

WARNINGS SECTION

  • For external use only
  • If symptoms persist or worsen, discontinue use and seek medical attention.
  • Avoid contact with eyes. If product gets into eyes, flush with water. Seek medical attention.
  • Not for use on open wounds.

Directions For Use:

DOSAGE & ADMINISTRATION SECTION

  • Remove protective wrapping.
  • Liberally apply gel to the affected area and rub into joints.
  • Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort.
  • Allow several days for drug to take maximum effect.

Other Information:

OTHER SAFETY INFORMATION

OTC - DO NOT USE SECTION

  • Do not use if container seal is broken prior to opening.
  • This product is intended for use in cases of recurring joint pain.
  • This product is NOT intended to treat disease, it provides a temporary level of comfort, relief and a feeling of wellness.
  • This product has been determined to be safe and effective for moderate to severe (Stage 3) chronic pain, as indicated by the Homeopathic Pharmacopeia of the United States.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Pregnant or nursing women and children should consult a physician before use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Benzalkonium chloride, Ethanol, Methocel, Propylene glycol, Saline

Principal Display Panel - 2 oz Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chronic Pain Relief

Nyloxin™

TOPICAL GEL ES
ROLL ON APPLICATOR

• Joint Pain
• Neck Pain
• Arthritis Pain
• Pain from Repetitive Stress

BREAKTHROUGH
Stage 3
Pain Relief

REGULAR STRENGTH

2 oz. net wt.

Made in the U.S.A.

Principal Display Panel - 2 oz Carton Label
Principal Display Panel - 2 oz Carton Label

Principal Display Panel - 2 oz Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chronic Pain Relief

Nyloxin™
RS

• Joint Pain
• Neck Pain
• Arthritis Pain
• Pain from Repetitive Stress

BREAKTHROUGH
Stage 3
Pain Relief

REGULAR STRENGTH
TOPICAL GEL
ROLL ON APPLICATOR

HOMEOPATHIC

2 oz. net wt.

Principal Display Panel - 2 oz Bottle Label
Principal Display Panel - 2 oz Bottle Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130347219311023GTIN-13: 0347219311023
EAN-13: 0347219311023
GTIN-12: 347219311023
UPC-A: 347219311023
GTIN storage (14 digits): 00347219311023		nyl06-0000-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47219-311-022024-01-30C16284748780-1ba0f9c33-47b5-a910-e053-dadaa90a0b85Nyloxin Topical Gel ES
47219-311-022024-01-30C16284748780-1ba0f9c33-47b5-a910-e053-dadaa90a0b85DRUG FACTS
47219-311-022021-07-14C16284748780-1ba0f9c33-47b5-a910-e053-dadaa90a0b85Nyloxin Topical Gel ES
47219-311-022021-07-14C16284748780-1ba0f9c33-47b5-a910-e053-dadaa90a0b85DRUG FACTS
47219-311-022021-01-29C16284748780-1ba0f9c33-47b5-a910-e053-dadaa90a0b85Nyloxin Topical Gel ES
47219-311-022021-01-29C16284748780-1ba0f9c33-47b5-a910-e053-dadaa90a0b85DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47219-311-02Nyloxin60 mL in 1 BOTTLE, WITH APPLICATORGEL605
47219-311-02Nyloxin1 in 1 BOXGEL15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NAJA NAJA VENOMACTIVE INGREDIENTZZ4AG7L7VM1
NAJA NAJA VENOMACTIVE MOIETYZZ4AG7L7VM1
AlcoholINACTIVE INGREDIENT3K9958V90M1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W71
Hydroxypropyl CelluloseINACTIVE INGREDIENTRFW2ET671P1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47219-31147219-311-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
NAJA NAJA VENOMZZ4AG7L7VMACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
ALCOHOL3K9958V90MIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42021-07-14full-release2026-06-01 02:14:41

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 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii+route
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii+route
16 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XGEL / TOPICAL0.18 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii+route
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii+route
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Hydroxypropyl CelluloseHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGEL / TOPICAL222 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XGEL / TOPICAL0.18 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii+route
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7GEL / OPHTHALMIC0.01 %w/wExact identifier — unii+dosage form
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii+route
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii+route
16 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7GEL / OPHTHALMIC0.01 %w/wExact identifier — unii+dosage form
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii+route
16 equally ranked IID candidates
Hydroxypropyl CelluloseHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGEL / TOPICAL222 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NyloxinNAJA NAJA VENOMNutra Pharma Corporationc28c50db-4b6b-4307-8fcb-9020d6ae9cd32025-10-20WarningsExact identifier
ndc (package): 47219-311-02
ndc (product): 47219-311
ndc11 (package): 47219031102
spl id: cc0046fd-33b6-462c-bae8-8cd20d5713fb
spl set id: c28c50db-4b6b-4307-8fcb-9020d6ae9cd3

Reported adverse events (FAERS/openFDA)#

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