MedPath
FDA Approval

Vax Sode

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

FDA Approval Summary

Company
Effective Date
May 15, 2025
Labeling Type
HUMAN OTC DRUG LABEL
thuja occidentalis leafy twig(6 [hp_X] in 1 mL)
Silicon dioxide(9 [hp_X] in 1 mL)
anguilla rostrata blood serum(18 [hp_X] in 1 mL)
Clostridium tetani(30 [hp_X] in 1 mL)
Rubella virus vaccine(30 [hp_X] in 1 mL)
yersinia enterocolitica(30 [hp_X] in 1 mL)
salmonella enterica enterica serovar enteritidis(18 [hp_C] in 1 mL)
Ostrea edulis shell(9 [hp_X] in 1 mL)

Products1

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

Vax Sode

Product Details

NDC Product Code
83027-0071
Route of Administration
ORAL
Effective Date
May 15, 2025
thuja occidentalis leafy twigActive
Code: 1NT28V9397Class: ACTIBQuantity: 6 [hp_X] in 1 mL
Code: ETJ7Z6XBU4Class: ACTIBQuantity: 9 [hp_X] in 1 mL
anguilla rostrata blood serumActive
Code: L7B16ESD1UClass: ACTIBQuantity: 18 [hp_X] in 1 mL
Code: 751E8J54VMClass: ACTIBQuantity: 30 [hp_X] in 1 mL
Code: HT3R7C012QClass: ACTIBQuantity: 30 [hp_X] in 1 mL
Code: YF0S03R447Class: ACTIBQuantity: 30 [hp_X] in 1 mL
Code: U751HEX436Class: ACTIBQuantity: 30 [hp_X] in 1 mL
yersinia enterocoliticaActive
Code: AUL7Y5Z806Class: ACTIBQuantity: 30 [hp_X] in 1 mL
salmonella enterica enterica serovar enteritidisActive
Code: Y3V16D4PV4Class: ACTIBQuantity: 18 [hp_C] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
Code: 2E32821G6IClass: ACTIBQuantity: 9 [hp_X] in 1 mL
Code: 760T5R8B3OClass: ACTIBQuantity: 18 [hp_X] in 1 mL
Code: JDS6958QAGClass: ACTIBQuantity: 30 [hp_X] 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 83027-0071-1

VAX-SODE

2 FL. OZ (60 ml)

VAX-SODE


INDICATIONS & USAGE SECTION

INDICATIONS:

Aids in temporary relief of symptoms including sweats, chills, minor aches of muscles and joints, fatigue and headache.†

†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:

Thuja Occidentalis 6X, 30X, Calcarea Carbonica 9X, 30X, Silicea 9X, 30X, Salmonella Typhi Nosode 18X, Serum Anguillae 18X, Bacillus Tetani (Clostridium Tetani) 30X, Malandrinum 30X, Morbillinum 30X, Parotidinum 30X, Rubella Nosode 30X, Yersinia Enterocolitica 30X, Salmonella Enteriditis 18C.

OTC - PURPOSE SECTION

PURPOSE:

Aids in temporary relief of symptoms including sweats, chills, minor aches of muscles and joints, fatigue and headache.†

†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.


© Copyright 2025. All Rights Reserved by MedPath