Home NDC 83027-0047 Bactex
Product NDC 83027-0047
11-digit product format 830270047
Labeler code 83027
Product ID 83027-0047_07bc64c9-4abf-4a6e-8e03-926567817886
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
Marketing end 2026-12-30
Substance ALOE; GOLDENSEAL; GARLIC; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; CLOSTRIDIUM TETANI; BRUCELLA ABORTUS; ESCHERICHIA COLI; KLEBSIELLA PNEUMONIAE; MYCOPLASMA PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS VIRIDANS GROUP; DELPHINIUM STAPHISAGRIA SEED; EUCALYPTOL; RANCID BEEF; CANIS LUPUS FAMILIARIS MILK; COW MILK; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; BACILLUS CEREUS; CLOSTRIDIUM PERFRINGENS; COXIELLA BURNETII; RICKETTSIA PROWAZEKII; SERRATIA MARCESCENS
Active strength 6; 6; 12; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 16; 20; 20; 30; 30; 30; 18; 18; 18; 18; 18 [hp_X]/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_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; [hp_C]/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
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 Bactex Active Ingredients# Ingredient, Strength table Ingredient Strength ALOE 6 [hp_X]/mL GOLDENSEAL 6 [hp_X]/mL GARLIC 12 [hp_X]/mL BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 16 [hp_X]/mL CLOSTRIDIUM TETANI 16 [hp_X]/mL BRUCELLA ABORTUS 16 [hp_X]/mL ESCHERICHIA COLI 16 [hp_X]/mL KLEBSIELLA PNEUMONIAE 16 [hp_Q]/mL MYCOPLASMA PNEUMONIAE 16 [hp_X]/mL STREPTOCOCCUS PNEUMONIAE 16 [hp_X]/mL PROTEUS VULGARIS 16 [hp_X]/mL PSEUDOMONAS AERUGINOSA 16 [hp_X]/mL STAPHYLOCOCCUS AUREUS 16 [hp_X]/mL STREPTOCOCCUS VIRIDANS GROUP 16 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED 16 [hp_X]/mL EUCALYPTOL 20 [hp_X]/mL RANCID BEEF 20 [hp_X]/mL CANIS LUPUS FAMILIARIS MILK 30 [hp_X]/mL COW MILK 30 [hp_X]/mL HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED 30 [hp_X]/mL BACILLUS CEREUS 18 [hp_C]/mL CLOSTRIDIUM PERFRINGENS 18 [hp_C]/mL COXIELLA BURNETII 18 [hp_C]/mL RICKETTSIA PROWAZEKII 18 [hp_C]/mL SERRATIA MARCESCENS 18 [hp_C]/mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83027-0047-1 Bactex 60 mL in 1 BOTTLE, SPRAY SPRAY 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83027-0047 BACTEX (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.] 1 Current NDC, 1 package rows 20230919_c6055c02-a365-4adf-9d3a-47d717c4c93d.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bactex 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 Nutritional Specialties, Inc. c6055c02-a365-4adf-9d3a-47d717c4c93d 2023-09-15 Warnings Exact identifier ndc (product): 83027-0047
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83027-0047-1 83027004701 60 mL in 1 BOTTLE, SPRAY (83027-0047-1) 60 ml 2023-09-15 2026-12-30 No No Historical