NYLOXIN

Manufacturer: RECEPTOPHARM INC | LIQUID PACKAGING RESOURCES
Effective date: 2009-11-30
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:02:49

Label at a glance#

ProductNYLOXIN Stage 3 Pain Relief

Active ingredientNAJA NAJA VENOM

Label structure10 sections

Dosage and administration

Break off protective tab. Turn press lock so spray nozzle is visible in front. Press down 4 x to prime the pump. Spray 2 x directly into mouth or under tongue. Use spray intially every 3-4 hours.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Asian Cobra venom 140 mcg/mL

Purpose

OTC - PURPOSE SECTION

Analgesic^*

* According to the Homeopathic Pharmacopeia of the United States

INDICATIONS & USAGE SECTION

Uses: Temporarily relieves pain associated with sore back, inflamed joints, migraines, painful menses, and general presistent pain

Warnings:

WARNINGS SECTION

Side effects may include headache, nausea, sore throat, allergic rhinitis and gastrointestinal upset.
If symptoms persist or worsen, stop using this product and consult a physician.
When Using This Product: avoid contact with the eyes. If product gets into eyes, flush with water. Seek medical attention.

Directions For Use:

DOSAGE & ADMINISTRATION SECTION

Break off protective tab.
Turn press lock so spray nozzle is visible in front.
Press down 4 x to prime the pump.
Spray 2 x directly into mouth or under tongue.
Use spray intially every 3-4 hours.

Other Information:

SPL UNCLASSIFIED SECTION

Do not use if tamper-proof seal is broken.
This product is NOT intended to treat disease, it can provide 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 2) pain.
Clinical experience suggests Nyloxin may provide relief from other forms of pain.

SPL UNCLASSIFIED SECTION

Pregnant or nursing women and children should not use this product unless advised by a physician.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric Acid, Ethanol, Flavoring, Methylparaben, Sodium Citrate, Xylitol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel – 1.0 oz Spray Label

1.0 oz Spray Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel – 1.0 oz Spray Carton

1.0 oz Spray Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
47219-250-10	2019-10-21	C162847	48780-1	956f9ecf-c05d-621f-e053-dbdaa90a74ad	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47219-250-10	NYLOXINStage 3 Pain Relief	1 in 1 BOX	SPRAY, METERED	1		1
47219-250-10	NYLOXINStage 3 Pain Relief	30 mL in 1 BOTTLE, SPRAY	SPRAY, METERED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47219-250	NYLOXIN STAGE 3 PAIN RELIEF (NAJA NAJA VENOM) SPRAY, METERED [RECEPTOPHARM INC]	1	Legacy NDC, 2 package rows	20110113_33c96620-d90e-11de-8f2e-0002a5d5c51b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NAJA NAJA VENOM	ACTIVE INGREDIENT	ZZ4AG7L7VM	1
NAJA NAJA VENOM	ACTIVE MOIETY	ZZ4AG7L7VM	1
2-(DIETHYLAMINO)ETHANOL	INACTIVE INGREDIENT	S6DL4M053U	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	1
ANHYDROUS TRISODIUM CITRATE	INACTIVE INGREDIENT	RS7A450LGA	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

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

NYLOXIN Stage 3 Pain Relief
NAJA NAJA VENOM
ANHYDROUS CITRIC ACID
ANHYDROUS TRISODIUM CITRATE
METHYLPARABEN
XYLITOL
2-(DIETHYLAMINO)ETHANOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
47219-250	47219-250-10

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
Name	UNII	Kind
NAJA NAJA VENOM	ZZ4AG7L7VM	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
XYLITOL	VCQ006KQ1E	IACT
2-(DIETHYLAMINO)ETHANOL	S6DL4M053U	IACT

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 4 · 182 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION, CONCENTRATE / INTRAVENOUS		60 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE, LIQUID FILLED / ORAL		360 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRAMUSCULAR		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATE	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	SUSPENSION / RESPIRATORY (INHALATION)		2 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / ORAL		46 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / SUBLINGUAL		36 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		81 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / RECTAL		904 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATE	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	INJECTION / INTRAMUSCULAR		792 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATE	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	INJECTION, SOLUTION / INTRAVENOUS		24 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / SUBCUTANEOUS		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATE	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	LOTION / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATE	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		414 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM / BUCCAL		9 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / PERINEURAL	0.02 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / RESPIRATORY (INHALATION)		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATE	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	TABLET / SUBLINGUAL		36 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CREAM / TOPICAL		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2ce90140-d912-11de-b0c5-0002a5d5c51b			33c96620-d90e-11de-8f2e-0002a5d5c51b	2009-11-30	Warnings	Exact identifier spl id: 2ce90140-d912-11de-b0c5-0002a5d5c51b spl set id: 33c96620-d90e-11de-8f2e-0002a5d5c51b

Reported adverse events (FAERS/openFDA)#

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