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
BACILLUS CEREUS; CHLAMYDIA TRACHOMATIS; CLOSTRIDIUM TETANI; ESCHERICHIA COLI; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; KLEBSIELLA PNEUMONIAE; MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS; MYCOPLASMA PNEUMONIAE; RANCID BEEF; SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS VIRIDANS GROUP
Active strength
18; 16; 16; 16; 30; 16; 16; 16; 20; 16; 16; 15; 15; 15; 16; 16 [hp_C]/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_X]/mL; [hp_X]/mL
NDC exclude flag
No
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

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

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

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

Additional Listing Data#

Finished product
Yes
Brand name base
Bacti Sode

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOSTRIDIUM TETANI18 [hp_C]/mL
CHLAMYDIA TRACHOMATIS16 [hp_X]/mL
ESCHERICHIA COLI16 [hp_X]/mL
KLEBSIELLA PNEUMONIAE16 [hp_X]/mL
MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS30 [hp_X]/mL
MYCOPLASMA PNEUMONIAE16 [hp_X]/mL
STREPTOCOCCUS PNEUMONIAE16 [hp_X]/mL
SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI16 [hp_X]/mL
STAPHYLOCOCCUS AUREUS20 [hp_X]/mL
STREPTOCOCCUS VIRIDANS GROUP16 [hp_X]/mL
RANCID BEEF16 [hp_X]/mL
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED15 [hp_C]/mL
STREPTOCOCCUS AGALACTIAE15 [hp_C]/mL
STREPTOCOCCUS DYSGALACTIAE15 [hp_C]/mL
STREPTOCOCCUS MUTANS16 [hp_X]/mL
BACILLUS CEREUS16 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii751E8J54VM, T6NI39QU44, 514B9K0L10, 09PA36CT5R, XH0F4IP2RX, JQE470FAD0, BT6U234YR2, 760T5R8B3O, O478WX4004, NNV2379HKR, 29SUH5R3HU, U364V64HUN, 2B3763S671, LN0SH02Y5M, 5C7J33MJJ1, 7YC151N82L

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

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