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Bacti Sode

DRUG FACTS:

Approved
Approval ID

46816822-d850-44a7-a053-1c1bc12731c4

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.

Bacillus Tetani, Chlamydia Trachomatis, Colibacillinum Cum Natrum Muriaticum, Klebsiella Pneumoniae, Mycobacterium Paratuberculosis, Mycoplasma Pneumoniae, Pneumococcinum, Salmonella Typhi Nosode, Staphylococcus Aureus, Streptococcus Viridans, Pyrogenium, Pertussinum, Streptococcus Agalactiae, Streptococcus Dysgalactiae, Streptococcus Mutans, Bacillus Cereus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83027-0069
Product Classification
G
Generic Name
Bacillus Tetani, Chlamydia Trachomatis, Colibacillinum Cum Natrum Muriaticum, Klebsiella Pneumoniae, Mycobacterium Paratuberculosis, Mycoplasma Pneumoniae, Pneumococcinum, Salmonella Typhi Nosode, Staphylococcus Aureus, Streptococcus Viridans, Pyrogenium, Pertussinum, Streptococcus Agalactiae, Streptococcus Dysgalactiae, Streptococcus Mutans, Bacillus Cereus
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (18)

CLOSTRIDIUM TETANIActive
Quantity: 16 [hp_X] in 1 mL
Code: 751E8J54VM
Classification: ACTIB
ESCHERICHIA COLIActive
Quantity: 16 [hp_X] in 1 mL
Code: 514B9K0L10
Classification: ACTIB
MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSISActive
Quantity: 16 [hp_X] in 1 mL
Code: XH0F4IP2RX
Classification: ACTIB
STREPTOCOCCUS PNEUMONIAEActive
Quantity: 16 [hp_X] in 1 mL
Code: BT6U234YR2
Classification: ACTIB
STREPTOCOCCUS VIRIDANS GROUPActive
Quantity: 16 [hp_X] in 1 mL
Code: NNV2379HKR
Classification: ACTIB
STREPTOCOCCUS AGALACTIAEActive
Quantity: 15 [hp_C] in 1 mL
Code: 2B3763S671
Classification: ACTIB
STREPTOCOCCUS DYSGALACTIAEActive
Quantity: 15 [hp_C] in 1 mL
Code: LN0SH02Y5M
Classification: ACTIB
BACILLUS CEREUSActive
Quantity: 18 [hp_C] in 1 mL
Code: 7YC151N82L
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CHLAMYDIA TRACHOMATISActive
Quantity: 16 [hp_X] in 1 mL
Code: T6NI39QU44
Classification: ACTIB
KLEBSIELLA PNEUMONIAEActive
Quantity: 16 [hp_X] in 1 mL
Code: 09PA36CT5R
Classification: ACTIB
MYCOPLASMA PNEUMONIAEActive
Quantity: 16 [hp_X] in 1 mL
Code: JQE470FAD0
Classification: ACTIB
STAPHYLOCOCCUS AUREUSActive
Quantity: 16 [hp_X] in 1 mL
Code: O478WX4004
Classification: ACTIB
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTEDActive
Quantity: 30 [hp_X] in 1 mL
Code: U364V64HUN
Classification: ACTIB
SALMONELLA ENTERICA ENTERICA SEROVAR TYPHIActive
Quantity: 16 [hp_X] in 1 mL
Code: 760T5R8B3O
Classification: ACTIB
RANCID BEEFActive
Quantity: 20 [hp_X] in 1 mL
Code: 29SUH5R3HU
Classification: ACTIB
STREPTOCOCCUS MUTANSActive
Quantity: 15 [hp_C] in 1 mL
Code: 5C7J33MJJ1
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/3/2023

PACKAGE LABEL DISPLAY:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0069-1

BACTI-SODE

2 FL. OZ (60 ml)

BACTI-SODE

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/3/2023

INDICATIONS:

Aids in temporary relief of headache, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.†

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/3/2023

ACTIVE INGREDIENTS:

Bacillus Tetani 16X, Chlamydia Trachomatis 16X, Colibacillinum Cum Natrum Muriaticum (e Coli) 16X, Klebsiella Pneumoniae 16X, Mycobacterium Paratuberculosis 16X, Mycoplasma Pneumoniae 16X, Pneumococcinum 16X, Salmonella Typhi Nosode 16X, Staphylococcus Aureus 16X, Streptococcus Viridans 16X, Pyrogenium 20X, Pertussinum 30X, Streptococcus Agalactiae 15C, Streptococcus Dysgalactiae 15C, Streptococcus Mutans 15C, Bacillus Cereus 18C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/3/2023

PURPOSE:

Aids in temporary relief of headache, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.†

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

WARNINGS SECTION

LOINC: 34071-1Updated: 5/3/2023

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: 5/3/2023

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: 5/3/2023

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: 5/3/2023

INACTIVE INGREDIENTS:

Alcohol USP 20%, Purified Water USP.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/3/2023

QUESTIONS:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

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Bacti Sode - FDA Drug Approval Details