Bactex
- Product NDC
- 83027-0047
- Requested package NDC
- 83027-0047-1
- 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 |
|---|---|
| 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 | 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 | 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.
| 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 | 83027-0047-1 83027-0047 83027004701 |
Packages#
| 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 |