MedPath

Vax Sode

DRUG FACTS:

Approved
Approval ID

6f8cfcad-4d23-44d3-9369-22b575b1e7e6

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.

Thuja Occidentalis, Calcarea Carbonica, Silicea, Salmonella Typhi Nosode, Serum Anguillae, Bacillus Tetani(Clostridium Tetani), Malandrinum, Morbillinum, Parotidinum, Rubella Nosode, Yersinia Enterocolitica, Salmonella Enteriditis

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83027-0071
Product Classification
G
Generic Name
Thuja Occidentalis, Calcarea Carbonica, Silicea, Salmonella Typhi Nosode, Serum Anguillae, Bacillus Tetani(Clostridium Tetani), Malandrinum, Morbillinum, Parotidinum, Rubella Nosode, Yersinia Enterocolitica, Salmonella Enteriditis
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (14)

THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 6 [hp_X] in 1 mL
Code: 1NT28V9397
Classification: ACTIB
SILICON DIOXIDEActive
Quantity: 9 [hp_X] in 1 mL
Code: ETJ7Z6XBU4
Classification: ACTIB
ANGUILLA ROSTRATA BLOOD SERUMActive
Quantity: 18 [hp_X] in 1 mL
Code: L7B16ESD1U
Classification: ACTIB
CLOSTRIDIUM TETANIActive
Quantity: 30 [hp_X] in 1 mL
Code: 751E8J54VM
Classification: ACTIB
MEASLES VIRUSActive
Quantity: 30 [hp_X] in 1 mL
Code: HT3R7C012Q
Classification: ACTIB
MUMPS VIRUSActive
Quantity: 30 [hp_X] in 1 mL
Code: YF0S03R447
Classification: ACTIB
RUBELLA VIRUSActive
Quantity: 30 [hp_X] in 1 mL
Code: U751HEX436
Classification: ACTIB
YERSINIA ENTEROCOLITICAActive
Quantity: 30 [hp_X] in 1 mL
Code: AUL7Y5Z806
Classification: ACTIB
SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDISActive
Quantity: 18 [hp_C] in 1 mL
Code: Y3V16D4PV4
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
OYSTER SHELL CALCIUM CARBONATE, CRUDEActive
Quantity: 9 [hp_X] in 1 mL
Code: 2E32821G6I
Classification: ACTIB
SALMONELLA ENTERICA ENTERICA SEROVAR TYPHIActive
Quantity: 18 [hp_X] in 1 mL
Code: 760T5R8B3O
Classification: ACTIB
VACCINIA VIRUSActive
Quantity: 30 [hp_X] in 1 mL
Code: JDS6958QAG
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/11/2023

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0071-1

VAX-SODE

2 FL. OZ (60 ml)

VAX-SODE

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/11/2023

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.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/11/2023

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 - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/11/2023

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.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/11/2023

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: 9/11/2023

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: 9/11/2023

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: 9/11/2023

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/11/2023

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

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