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Viri Sode

DRUG FACTS:

Approved
Approval ID

96512394-a9d8-488d-ba88-b15d3d988f61

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 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.

Cytomegalovirus Nosode, Herpes Simplex I Nosode, Herpes Simplex II Nosode, Influenzinum, Rubella Nosode, Hepatitis A Nosode, Hepatitis B Nosode, Hepatitis C Nosode, Epstein Barr Virus Nosode, Herpes Zoster Nosode

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83027-0070
Product Classification
G
Generic Name
Cytomegalovirus Nosode, Herpes Simplex I Nosode, Herpes Simplex II Nosode, Influenzinum, Rubella Nosode, Hepatitis A Nosode, Hepatitis B Nosode, Hepatitis C Nosode, Epstein Barr Virus Nosode, Herpes Zoster Nosode
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (15)

RUBELLA VIRUSActive
Quantity: 16 [hp_X] in 1 mL
Code: U751HEX436
Classification: ACTIB
INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)Active
Quantity: 16 [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: 16 [hp_X] in 1 mL
Code: P483J7GX6D
Classification: ACTIB
INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)Active
Quantity: 16 [hp_X] in 1 mL
Code: TBV2PPG6EF
Classification: ACTIB
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)Active
Quantity: 16 [hp_X] in 1 mL
Code: H2198F8ZNA
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HEPATITIS B VIRUSActive
Quantity: 30 [hp_X] in 1 mL
Code: 77H9EM77P7
Classification: ACTIB
HEPATITIS C VIRUSActive
Quantity: 30 [hp_X] in 1 mL
Code: QI56415283
Classification: ACTIB
HEPATITIS A VIRUSActive
Quantity: 30 [hp_X] in 1 mL
Code: G54MT8V18G
Classification: ACTIB
HUMAN HERPESVIRUS 5Active
Quantity: 16 [hp_X] in 1 mL
Code: 7COI029E6K
Classification: ACTIB
HUMAN HERPESVIRUS 1Active
Quantity: 16 [hp_X] in 1 mL
Code: 22G38P19RL
Classification: ACTIB
HUMAN HERPESVIRUS 2Active
Quantity: 16 [hp_X] in 1 mL
Code: 74J6DNH49U
Classification: ACTIB
HUMAN HERPESVIRUS 3Active
Quantity: 15 [hp_C] in 1 mL
Code: 9885M7D6JP
Classification: ACTIB
HUMAN HERPESVIRUS 4Active
Quantity: 15 [hp_C] in 1 mL
Code: 2A26YW7PNX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/31/2023

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0070-1

VIRI-SODE

2 FL. OZ (60 ml)

VIRI-SODE

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/31/2023

INDICATIONS:

Aids in temporary relief of symptoms including fatigue, 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 - PURPOSE SECTION

LOINC: 55105-1Updated: 5/31/2023

PURPOSE:

Aids in temporary relief of symptoms including fatigue, 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: 5/31/2023

ACTIVE INGREDIENTS:

Cytomegalovirus Nosode 16X, Herpes Simplex I Nosode 16X, Herpes Simplex II Nosode 16, Influenzinum 16X, Rubella Nosode 16X, Hepatitis A Nosode 30X, Hepatitis B Nosode 30X, Hepatitis C Nosode 30X, Epstein Barr Virus Nosode 15C, Herpes Zoster Nosode 15C.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/31/2023

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: 5/31/2023

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: 5/31/2023

DIRECTIONS:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage.

For high sensitive individuals: best tolerated administration is through imbrication (RUBBING IN) on skin at pulse points or abdomen.

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: 5/31/2023

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/31/2023

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

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Viri Sode - FDA Drug Approval Details