FDA.reportPublic FDA data

Bacti Sode

Product NDC
83027-0152
11-digit product format
830270152
Labeler code
83027
Product ID
83027-0152_3a8f0bb4-9f0d-4cb8-b343-3cf2d1ba1391
Type
HUMAN OTC DRUG
Nonproprietary 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
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-04-29
Substance
CLOSTRIDIUM TETANI; CHLAMYDIA TRACHOMATIS; ESCHERICHIA COLI; KLEBSIELLA PNEUMONIAE; MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS; MYCOPLASMA PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS VIRIDANS GROUP; RANCID BEEF; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS MUTANS; BACILLUS CEREUS
Active strength
20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 30; 15; 15; 15; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Bacti Sode
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOSTRIDIUM TETANI20 [hp_X]/mL
CHLAMYDIA TRACHOMATIS20 [hp_X]/mL
ESCHERICHIA COLI20 [hp_X]/mL
KLEBSIELLA PNEUMONIAE20 [hp_X]/mL
MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS20 [hp_X]/mL
MYCOPLASMA PNEUMONIAE20 [hp_X]/mL
STREPTOCOCCUS PNEUMONIAE20 [hp_X]/mL
SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI20 [hp_X]/mL
STAPHYLOCOCCUS AUREUS20 [hp_X]/mL
STREPTOCOCCUS VIRIDANS GROUP20 [hp_X]/mL
RANCID BEEF20 [hp_X]/mL
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED30 [hp_X]/mL
STREPTOCOCCUS AGALACTIAE15 [hp_C]/mL
STREPTOCOCCUS DYSGALACTIAE15 [hp_C]/mL
STREPTOCOCCUS MUTANS15 [hp_C]/mL
BACILLUS CEREUS18 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
751E8J54VMInternal UNII lookup
T6NI39QU44Internal UNII lookup
514B9K0L10Internal UNII lookup
09PA36CT5RInternal UNII lookup
XH0F4IP2RXInternal UNII lookup
JQE470FAD0Internal UNII lookup
BT6U234YR2Internal UNII lookup
760T5R8B3OInternal UNII lookup
O478WX4004Internal UNII lookup
NNV2379HKRInternal UNII lookup
29SUH5R3HUInternal UNII lookup
U364V64HUNInternal UNII lookup
2B3763S671Internal UNII lookup
LN0SH02Y5MInternal UNII lookup
5C7J33MJJ1Internal UNII lookup
7YC151N82LInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a56ddc9-2550-4a6a-a553-3bc919b844f0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0152-1Bacti Sode60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0152BACTI SODE (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) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20250430_5a56ddc9-2550-4a6a-a553-3bc919b844f0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacti SodeBACILLUS 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 CEREUSNutritional Specialties, Inc.5a56ddc9-2550-4a6a-a553-3bc919b844f02025-04-29WarningsExact identifier
ndc (product): 83027-0152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0152-18302701520160 mL in 1 BOTTLE, SPRAY (83027-0152-1) 60 ml2025-04-29NoNoCurrent