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Virex

DRUG FACTS:

Approved
Approval ID

a37728d6-2428-42f7-b331-c07cdc4e9956

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Nutritional Specialties, Inc.

DUNS: 032744609

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Asclepias Tuberosa, Echinacea Purpurea, Trifolium Pratense, Natrum Muriaticum, Phytolacca Decandra, Euphrasia Officinalis, Lac Vaccinum (NSPC), Thuja Occidentalis, Calcarea Arsenicica, Camphora, Influenzinum, Cytomegalovirus Nosode, Morbillinum, Variolinum, Coxsackie A2 Nosode, Coxsackie A3 Nosode, Coxsackie A4 Nosode, Coxsackie A7 Nosode, Coxsackie B1 Nosode, Coxsackie B3 Nosode, Coxsackie B5 Nosode, Coxsackie A5 Nosode, Adenoviren Nosode, Epstein Barr Virus Nosode, Coxsackie B4 Nosode

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83027-0050
Product Classification
G
Generic Name
Asclepias Tuberosa, Echinacea Purpurea, Trifolium Pratense, Natrum Muriaticum, Phytolacca Decandra, Euphrasia Officinalis, Lac Vaccinum (NSPC), Thuja Occidentalis, Calcarea Arsenicica, Camphora, Influenzinum, Cytomegalovirus Nosode, Morbillinum, Variolinum, Coxsackie A2 Nosode, Coxsackie A3 Nosode, Coxsackie A4 Nosode, Coxsackie A7 Nosode, Coxsackie B1 Nosode, Coxsackie B3 Nosode, Coxsackie B5 Nosode, Coxsackie A5 Nosode, Adenoviren Nosode, Epstein Barr Virus Nosode, Coxsackie B4 Nosode
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (28)

ASCLEPIAS TUBEROSA ROOTActive
Quantity: 3 [hp_X] in 1 mL
Code: 1ZL82U5D18
Classification: ACTIB
ECHINACEA PURPUREA WHOLEActive
Quantity: 3 [hp_X] in 1 mL
Code: QI7G114Y98
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 4 [hp_X] in 1 mL
Code: 451W47IQ8X
Classification: ACTIB
EUPHRASIA STRICTAActive
Quantity: 6 [hp_X] in 1 mL
Code: C9642I91WL
Classification: ACTIB
COW MILKActive
Quantity: 6 [hp_X] in 1 mL
Code: 917J3173FT
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 6 [hp_X] in 1 mL
Code: 1NT28V9397
Classification: ACTIB
CALCIUM ARSENATEActive
Quantity: 12 [hp_X] in 1 mL
Code: 95OX15I8ZU
Classification: ACTIB
CAMPHOR (NATURAL)Active
Quantity: 12 [hp_X] in 1 mL
Code: N20HL7Q941
Classification: ACTIB
INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)Active
Quantity: 12 [hp_X] in 1 mL
Code: 34C49NV47P
Classification: ACTIB
INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)Active
Quantity: 12 [hp_X] in 1 mL
Code: P483J7GX6D
Classification: ACTIB
INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)Active
Quantity: 12 [hp_X] in 1 mL
Code: TBV2PPG6EF
Classification: ACTIB
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)Active
Quantity: 12 [hp_X] in 1 mL
Code: H2198F8ZNA
Classification: ACTIB
MEASLES VIRUSActive
Quantity: 16 [hp_X] in 1 mL
Code: HT3R7C012Q
Classification: ACTIB
HUMAN COXSACKIEVIRUS A2Active
Quantity: 9 [hp_C] in 1 mL
Code: 82KK5J435E
Classification: ACTIB
HUMAN COXSACKIEVIRUS A7Active
Quantity: 9 [hp_C] in 1 mL
Code: P3026TK92O
Classification: ACTIB
HUMAN COXSACKIEVIRUS B5Active
Quantity: 9 [hp_C] in 1 mL
Code: 63E6RXM429
Classification: ACTIB
HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGENActive
Quantity: 15 [hp_C] in 1 mL
Code: FKD3DUK39I
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TRIFOLIUM PRATENSE FLOWERActive
Quantity: 3 [hp_X] in 1 mL
Code: 4JS0838828
Classification: ACTIB
PHYTOLACCA AMERICANA ROOTActive
Quantity: 4 [hp_X] in 1 mL
Code: 11E6VI8VEG
Classification: ACTIB
HUMAN HERPESVIRUS 5Active
Quantity: 15 [hp_X] in 1 mL
Code: 7COI029E6K
Classification: ACTIB
VARIOLA VIRUSActive
Quantity: 16 [hp_X] in 1 mL
Code: 7J6DBS5FRN
Classification: ACTIB
HUMAN COXSACKIEVIRUS B1Active
Quantity: 9 [hp_C] in 1 mL
Code: ADL68M27WD
Classification: ACTIB
HUMAN COXSACKIEVIRUS AActive
Quantity: 9 [hp_C] in 1 mL
Code: 6F61V9UVRC
Classification: ACTIB
HUMAN COXSACKIEVIRUS B3Active
Quantity: 9 [hp_C] in 1 mL
Code: 69O1DAO10G
Classification: ACTIB
HUMAN HERPESVIRUS 4Active
Quantity: 15 [hp_C] in 1 mL
Code: 2A26YW7PNX
Classification: ACTIB
HUMAN COXSACKIEVIRUS BActive
Quantity: 18 [hp_C] in 1 mL
Code: NCM5G1A67U
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/13/2023

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0050-1

VIREX

2 FL. OZ (60 ml)

VIREX

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/13/2023

INDICATIONS:

Aids in temporary relief of symptoms including occasional headaches, sweats, chills, runny nose, and minor aches of muscles and joints.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/13/2023

ACTIVE INGREDIENTS:

Asclepias Tuberosa 3X, Echinacea Purpurea 3X, Trifolium Pratense 3X, Natrum Muriaticum 4X, Phytolacca Decandra 4X, Euphrasia Officinalis 6X, Lac Vaccinum 6X, Thuja Occidentalis 6X, 12X, 30X, Calcarea Arsenicica 12X, Camphora 12X, Influenzinum 12X, 30X, 60X, Cytomegalovirus Nosode 15X, 30X, 60X, Morbillinum 16X, 30X, 60X, Variolinum 16X, 30X, 60X, Coxsackie A2 Nosode 9C, Coxsackie A3 Nosode 9C, Coxsackie A4 Nosode 9C, Coxsackie A7 Nosode 9C, Coxsackie B1 Nosode 9C, Coxsackie B3 Nosode 9C, Coxsackie B5 Nosode 9C, Coxsackie A5 Nosode 15C, Adenoviren Nosode 15C, 30C, Epstein-Barr Virus Nosode 15C, 30C, Coxsackie B4 Nosode 18C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/13/2023

PURPOSE:

Aids in temporary relief of symptoms including occasional headaches, sweats, chills, runny nose, and minor aches of muscles and joints.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS SECTION

LOINC: 34071-1Updated: 4/13/2023

WARNINGS:

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/13/2023

KEEP OUT OF REACH OF CHILDREN:

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/13/2023

DIRECTIONS:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/13/2023

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/13/2023

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

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Virex - FDA Drug Approval Details