Bacti Sode

Product NDC
83027-0069
11-digit product format
830270069
Labeler code
83027
Product ID
83027-0069_25852327-53e2-4491-8883-8bdcd37e64fa
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
2023-05-03
Marketing end
2028-10-16
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
16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 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
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOSTRIDIUM TETANI16 [hp_X]/mL
CHLAMYDIA TRACHOMATIS16 [hp_X]/mL
ESCHERICHIA COLI16 [hp_X]/mL
KLEBSIELLA PNEUMONIAE16 [hp_X]/mL
MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS16 [hp_X]/mL
MYCOPLASMA PNEUMONIAE16 [hp_X]/mL
STREPTOCOCCUS PNEUMONIAE16 [hp_X]/mL
SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI16 [hp_X]/mL
STAPHYLOCOCCUS AUREUS16 [hp_X]/mL
STREPTOCOCCUS VIRIDANS GROUP16 [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
46816822-d850-44a7-a053-1c1bc12731c4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0069-1Bacti Sode60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0069BACTI 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.]2Current NDC, 1 package rows20250523_46816822-d850-44a7-a053-1c1bc12731c4.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.46816822-d850-44a7-a053-1c1bc12731c42025-05-21WarningsExact identifier
ndc (product): 83027-0069

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83027-0069-18302700690160 mL in 1 BOTTLE, SPRAY (83027-0069-1) 60 ml2023-05-032028-10-16NoNoHistorical