Bactex

Product NDC
83027-0047
11-digit product format
830270047
Labeler code
83027
Product ID
83027-0047_f5307c70-b68b-4d37-aabe-0139c0b587df
Type
HUMAN OTC DRUG
Nonproprietary name
Aloe, Hydrastis Canadensis, Allium Sativum, Anthracinum, Bacillus Tetani (Clostridium Tetani), Brucella Abortus, Colibacillinum Cum Natrum Muriaticum, Klebsiella Pneumoniae, Mycoplasma Pneumoniae, Pneumococcinum, Proteus (Vulgaris) Pseudomonas Aeruginosa, Staphylococcus Aureus, Streptococcus Viridans, Staphysagria, Eucalyptol, Pyrogenium, Lac Caninum, Lac Vaccinum, Pertussinum, Bacillus Cereus, Clostridium Perfringens, Coxiella Burnetii (Q Fever), Rickettsia Nosode, Serratia Marcescens
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-09-15
Substance
ALOE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BACILLUS CEREUS; BRUCELLA ABORTUS; CANIS LUPUS FAMILIARIS MILK; CLOSTRIDIUM PERFRINGENS; CLOSTRIDIUM TETANI; COW MILK; COXIELLA BURNETII; DELPHINIUM STAPHISAGRIA SEED; ESCHERICHIA COLI; EUCALYPTOL; GARLIC; GOLDENSEAL; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; KLEBSIELLA PNEUMONIAE; MYCOPLASMA PNEUMONIAE; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; RANCID BEEF; RICKETTSIA PROWAZEKII; SERRATIA MARCESCENS; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS VIRIDANS GROUP
Active strength
6; 16; 18; 16; 30; 18; 16; 30; 18; 16; 16; 20; 12; 6; 30; 16; 16; 16; 16; 20; 18; 18; 16; 16; 16 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALOE6 [hp_X]/mL
GOLDENSEAL16 [hp_X]/mL
GARLIC18 [hp_C]/mL
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT16 [hp_X]/mL
CLOSTRIDIUM TETANI30 [hp_X]/mL
BRUCELLA ABORTUS18 [hp_C]/mL
ESCHERICHIA COLI16 [hp_X]/mL
KLEBSIELLA PNEUMONIAE30 [hp_X]/mL
MYCOPLASMA PNEUMONIAE18 [hp_C]/mL
STREPTOCOCCUS PNEUMONIAE16 [hp_X]/mL
PROTEUS VULGARIS16 [hp_X]/mL
PSEUDOMONAS AERUGINOSA20 [hp_X]/mL
STAPHYLOCOCCUS AUREUS12 [hp_X]/mL
STREPTOCOCCUS VIRIDANS GROUP6 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED30 [hp_X]/mL
EUCALYPTOL16 [hp_Q]/mL
RANCID BEEF16 [hp_X]/mL
CANIS LUPUS FAMILIARIS MILK16 [hp_X]/mL
COW MILK16 [hp_X]/mL
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED20 [hp_X]/mL
BACILLUS CEREUS18 [hp_C]/mL
CLOSTRIDIUM PERFRINGENS18 [hp_C]/mL
COXIELLA BURNETII16 [hp_X]/mL
RICKETTSIA PROWAZEKII16 [hp_X]/mL
SERRATIA MARCESCENS16 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV5VD430YW9, ZW3Z11D0JV, V1V998DC17, 41LZ22DD4N, 751E8J54VM, 492LCM0TUL, 514B9K0L10, 09PA36CT5R, JQE470FAD0, BT6U234YR2, 11T9HCO30O, Y793W5V55N, O478WX4004, NNV2379HKR, 00543AP1JV, RV6J6604TK, 29SUH5R3HU, G39P120JQT, 917J3173FT, U364V64HUN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0047-1Bactex60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0047BACTEX (ALOE, HYDRASTIS CANADENSIS, ALLIUM SATIVUM, ANTHRACINUM, BACILLUS TETANI (CLOSTRIDIUM TETANI), BRUCELLA ABORTUS, COLIBACILLINUM CUM NATRUM MURIATICUM, KLEBSIELLA PNEUMONIAE, MYCOPLASMA PNEUMONIAE, PNEUMOCOCCINUM, PROTEUS (VULGARIS) PSEUDOMONAS AERUGINOSA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, STAPHYSAGRIA, EUCALYPTOL, PYROGENIUM, LAC CANINUM, LAC VACCINUM, PERTUSSINUM, BACILLUS CEREUS, CLOSTRIDIUM PERFRINGENS, COXIELLA BURNETII (Q FEVER), RICKETTSIA NOSODE, SERRATIA MARCESCENS) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20230919_c6055c02-a365-4adf-9d3a-47d717c4c93d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0047-18302700470160 mL in 1 BOTTLE, SPRAY (83027-0047-1) 60 ml2023-09-15NoNoHistorical