Home NDC 63479-1409 N09
Product NDC 63479-1409
11-digit product format 634791409
Labeler code 63479
Product ID 63479-1409_0e773c6a-0172-fae5-e063-6294a90af595
Type HUMAN OTC DRUG
Nonproprietary name ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALIS
Dosage form SOLUTION/ DROPS
Route SUBLINGUAL
Labeler Apex Energetics Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1994-12-15
Substance SILICON DIOXIDE; ONION; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; LACHESIS MUTA VENOM; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; ACONITUM NAPELLUS; GARLIC; ATROPA BELLADONNA; VIROLA SEBIFERA RESIN; THUJA OCCIDENTALIS LEAFY TWIG; CALCIUM SULFATE ANHYDROUS
Active strength 12; 30; 1; 1; 200; 90; 60; 1; 200; 30; 200; 2; 90; 60 [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_X]/mL; [hp_X]/mL
Pharmacologic classes Allergens [CS], Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 N09
Brand name suffix BACTEROTOX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILICON DIOXIDE 12 [hp_X]/mL ONION 30 [hp_X]/mL CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/mL ECHINACEA ANGUSTIFOLIA 1 [hp_X]/mL CALCIUM SULFIDE 200 [hp_X]/mL LACHESIS MUTA VENOM 90 [hp_X]/mL FERROSOFERRIC PHOSPHATE 60 [hp_X]/mL GOLDENSEAL 1 [hp_X]/mL ACONITUM NAPELLUS 200 [hp_X]/mL GARLIC 30 [hp_X]/mL ATROPA BELLADONNA 200 [hp_X]/mL VIROLA SEBIFERA RESIN 2 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG 90 [hp_X]/mL CALCIUM SULFATE ANHYDROUS 60 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 14 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63479-1409-1 N09BACTEROTOX 30 mL in 1 BOTTLE, GLASS SOLUTION/ DROPS 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63479-1409 N09 BACTEROTOX (ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALIS) SOLUTION/ DROPS [APEX ENERGETICS INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240110_ba99bb1e-c36f-8bf8-e053-2995a90ac308.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 N09 BACTEROTOX ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALIS Apex Energetics Inc. ba99bb1e-c36f-8bf8-e053-2995a90ac308 2024-01-08 Warnings Exact identifier ndc (product): 63479-1409
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63479-1409-1 63479140901 30 mL in 1 BOTTLE, GLASS (63479-1409-1) 30 ml 1994-12-15 0000-00-00 No No Current