N12
N12
Approved
Approval ID
ba5fbf07-d92b-2b1d-e053-2995a90a7e52
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
Apex Energetics Inc.
DUNS: 195816384
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, SUS SCROFA BONE MARROW, BRYONIA ALBA ROOT, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, OLEA EUROPAEA FLOWER, ULEX EUROPAEUS, FLOWER, LACHESIS MUTA VENOM, LEVISTICUM OFFICINALE, TREPONEMIC SKIN CANKER HUMAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63479-1412
Product Classification
G
Generic Name
ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, SUS SCROFA BONE MARROW, BRYONIA ALBA ROOT, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, OLEA EUROPAEA FLOWER, ULEX EUROPAEUS, FLOWER, LACHESIS MUTA VENOM, LEVISTICUM OFFICINALE, TREPONEMIC SKIN CANKER HUMAN
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (27)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
LEVISTICUM OFFICINALEActive
Quantity: 12 [hp_X] in 1 mL
Code: SZD8739PH1
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STAPHYLOCOCCUS HAEMOLYTICUSActive
Quantity: 30 [hp_X] in 1 mL
Code: 092IJ99835
Classification: ACTIB
STAPHYLOCOCCUS SIMULANSActive
Quantity: 30 [hp_X] in 1 mL
Code: V68E0X60VL
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 30 [hp_X] in 1 mL
Code: T7J046YI2B
Classification: ACTIB
ULEX EUROPAEUS FLOWERActive
Quantity: 30 [hp_X] in 1 mL
Code: 398DBS1PXN
Classification: ACTIB
GONORRHEAL URETHRAL SECRETION HUMANActive
Quantity: 30 [hp_X] in 1 mL
Code: 9BZG9E3I8F
Classification: ACTIB
SULFURActive
Quantity: 30 [hp_X] in 1 mL
Code: 70FD1KFU70
Classification: ACTIB
SUS SCROFA SPLEENActive
Quantity: 7 [hp_C] in 1 mL
Code: 92AMN5J79Y
Classification: ACTIB
BILBERRYActive
Quantity: 30 [hp_X] in 1 mL
Code: 9P2U39H18W
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 30 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
ECHINACEA PURPUREAActive
Quantity: 9 [hp_X] in 1 mL
Code: QI7G114Y98
Classification: ACTIB
OLEA EUROPAEA FLOWERActive
Quantity: 30 [hp_X] in 1 mL
Code: 498M34P1VZ
Classification: ACTIB
TUBERCULIN PURIFIED PROTEIN DERIVATIVEActive
Quantity: 30 [hp_X] in 1 mL
Code: I7L8FKN87J
Classification: ACTIB
VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGENActive
Quantity: 30 [hp_X] in 1 mL
Code: 4SV59689SK
Classification: ACTIB
TREPONEMIC SKIN CANKER HUMANActive
Quantity: 30 [hp_X] in 1 mL
Code: 4ZWP7FWI8W
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 30 [hp_X] in 1 mL
Code: 1NT28V9397
Classification: ACTIB
BAPTISIA TINCTORIA ROOTActive
Quantity: 15 [hp_X] in 1 mL
Code: 5EF0HWI5WU
Classification: ACTIB
STREPTOCOCCUS PYOGENESActive
Quantity: 30 [hp_X] in 1 mL
Code: LJ2LP0YL98
Classification: ACTIB
VISCUM ALBUM FRUITING TOPActive
Quantity: 12 [hp_X] in 1 mL
Code: BK9092J5MP
Classification: ACTIB
RANCID BEEFActive
Quantity: 30 [hp_X] in 1 mL
Code: 29SUH5R3HU
Classification: ACTIB
STAPHYLOCOCCUS EPIDERMIDISActive
Quantity: 30 [hp_X] in 1 mL
Code: D5T403TNGE
Classification: ACTIB
SALMONELLA ENTERICA ENTERICA SEROVAR TYPHIActive
Quantity: 60 [hp_X] in 1 mL
Code: 760T5R8B3O
Classification: ACTIB
SUS SCROFA BONE MARROWActive
Quantity: 7 [hp_C] in 1 mL
Code: VP2CN2G7Y8
Classification: ACTIB
ECHINACEA ANGUSTIFOLIAActive
Quantity: 9 [hp_X] in 1 mL
Code: VB06AV5US8
Classification: ACTIB
LACHESIS MUTA VENOMActive
Quantity: 30 [hp_X] in 1 mL
Code: VSW71SS07I
Classification: ACTIB