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FDA Approval

Viri Sode

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Nutritional Specialties, Inc.
DUNS: 032744609
Effective Date
May 15, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Rubella virus vaccine(16 [hp_X] in 1 mL)
Influenza A virus A/Victoria/2570/2019 IVR-215 (H1N1) antigen (UV, formaldehyde inactivated)(16 [hp_X] in 1 mL)
Influenza A virus A/Darwin/9/2021 IVR-228 (H3N2) antigen (UV, formaldehyde inactivated)(16 [hp_X] in 1 mL)
Influenza B virus B/Austria/1359417/2021 BVR-26 antigen (UV, formaldehyde inactivated)(16 [hp_X] in 1 mL)
Influenza B virus B/Phuket/3073/2013 antigen (UV, formaldehyde inactivated)(16 [hp_X] in 1 mL)
hepatitis B virus vaccine(30 [hp_X] in 1 mL)
Hepatitis C virus inhibitors(Progenics)(30 [hp_X] in 1 mL)
hepatitis A virus vaccine(30 [hp_X] in 1 mL)
Herpesvirus vector gene transfer therapy(University of Pennsylvania)(16 [hp_X] in 1 mL)
human herpesvirus 6 (HHV-6) U94/REP protein-based therapy (Biopharm Technology)(16 [hp_X] in 1 mL)
Herpesvirus vector gene transfer therapy(University of Pennsylvania)(16 [hp_X] in 1 mL)
Herpesvirus vector gene transfer therapy(University of Pennsylvania)(15 [hp_C] in 1 mL)
Herpesvirus vector gene transfer therapy(University of Pennsylvania)(15 [hp_C] in 1 mL)

Products1

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

Viri Sode

Product Details

NDC Product Code
83027-0070
Route of Administration
ORAL
Effective Date
May 15, 2025
Rubella virus vaccineActive
Code: U751HEX436Class: ACTIBQuantity: 16 [hp_X] in 1 mL
Influenza A virus A/Victoria/2570/2019 IVR-215 (H1N1) antigen (UV, formaldehyde inactivated)Active
Code: 34C49NV47PClass: ACTIBQuantity: 16 [hp_X] in 1 mL
Influenza A virus A/Darwin/9/2021 IVR-228 (H3N2) antigen (UV, formaldehyde inactivated)Active
Code: P483J7GX6DClass: ACTIBQuantity: 16 [hp_X] in 1 mL
Influenza B virus B/Austria/1359417/2021 BVR-26 antigen (UV, formaldehyde inactivated)Active
Code: TBV2PPG6EFClass: ACTIBQuantity: 16 [hp_X] in 1 mL
Influenza B virus B/Phuket/3073/2013 antigen (UV, formaldehyde inactivated)Active
Code: H2198F8ZNAClass: ACTIBQuantity: 16 [hp_X] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
hepatitis B virus vaccineActive
Code: 77H9EM77P7Class: ACTIBQuantity: 30 [hp_X] in 1 mL
Hepatitis C virus inhibitors(Progenics)Active
Code: QI56415283Class: ACTIBQuantity: 30 [hp_X] in 1 mL
hepatitis A virus vaccineActive
Code: G54MT8V18GClass: ACTIBQuantity: 30 [hp_X] in 1 mL
Herpesvirus vector gene transfer therapy(University of Pennsylvania)Active
Code: 7COI029E6KClass: ACTIBQuantity: 16 [hp_X] in 1 mL
human herpesvirus 6 (HHV-6) U94/REP protein-based therapy (Biopharm Technology)Active
Code: 22G38P19RLClass: ACTIBQuantity: 16 [hp_X] in 1 mL
Herpesvirus vector gene transfer therapy(University of Pennsylvania)Active
Code: 74J6DNH49UClass: ACTIBQuantity: 16 [hp_X] in 1 mL
Herpesvirus vector gene transfer therapy(University of Pennsylvania)Active
Code: 9885M7D6JPClass: ACTIBQuantity: 15 [hp_C] in 1 mL
Herpesvirus vector gene transfer therapy(University of Pennsylvania)Active
Code: 2A26YW7PNXClass: ACTIBQuantity: 15 [hp_C] in 1 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0070-1

VIRI-SODE

2 FL. OZ (60 ml)

VIRI-SODE

INDICATIONS & USAGE SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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.

WARNINGS SECTION

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 - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

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 - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN:

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

OTC - QUESTIONS SECTION

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

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