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
ACONITUM NAPELLUS; ATROPA BELLADONNA; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; GARLIC; GOLDENSEAL; LACHESIS MUTA VENOM; ONION; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; VIROLA SEBIFERA RESIN
Active strength
200; 200; 60; 200; 1; 1; 60; 30; 1; 90; 30; 12; 90; 2 [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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
N09
Brand name suffix
BACTEROTOX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS200 [hp_X]/mL
ATROPA BELLADONNA200 [hp_X]/mL
CALCIUM SULFATE ANHYDROUS60 [hp_X]/mL
CALCIUM SULFIDE200 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA1 [hp_X]/mL
FERROSOFERRIC PHOSPHATE60 [hp_X]/mL
GARLIC30 [hp_X]/mL
GOLDENSEAL1 [hp_X]/mL
LACHESIS MUTA VENOM90 [hp_X]/mL
ONION30 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG90 [hp_X]/mL
VIROLA SEBIFERA RESIN2 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, WQZ3G9PF0H, E934B3V59H, 1MBW07J51Q, 18E7415PXQ, VB06AV5US8, 91GQH8I5F7, V1V998DC17, ZW3Z11D0JV, VSW71SS07I, 492225Q21H, ETJ7Z6XBU4, 1NT28V9397, GHJ5XX5SGS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1409-1N09BACTEROTOX30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1409N09 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.]3Current NDC, Legacy NDC, 1 package rows20240110_ba99bb1e-c36f-8bf8-e053-2995a90ac308.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-1409-16347914090130 mL in 1 BOTTLE, GLASS (63479-1409-1) 30 ml1994-12-150000-00-00NoNoCurrent