FDA.reportPublic FDA data

A03

Product NDC
63479-0103
11-digit product format
634790103
Labeler code
63479
Product ID
63479-0103_0e765c65-dfc5-b0fa-e063-6294a90a4b51
Type
HUMAN OTC DRUG
Nonproprietary name
ALFALFA, AMERICAN GINSENG, APIS MELLIFICA, ASPARAGUS OFFICINALIS, AVENA SATIVA, BARYTA IODATA, BERBERIS VULGARIS, BRYONIA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, CONIUM MACULATUM, FERRUM IODATUM, LAPIS ALBUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, PASSIFLORA INCARNATA, SCROPHULARIA NODOSA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA URSI
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1994-12-15
Substance
ALFALFA; AMERICAN GINSENG; APIS MELLIFERA; ARCTOSTAPHYLOS UVA-URSI LEAF; ASPARAGUS; AVENA SATIVA FLOWERING TOP; BARIUM IODIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM HEXAFLUOROSILICATE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; FERROUS IODIDE; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; MILK THISTLE; PASSIFLORA INCARNATA FLOWERING TOP; SCROPHULARIA NODOSA; SODIUM CARBONATE; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE
Active strength
1; 2; 6; 1; 2; 1; 12; 1; 15; 15; 1; 12; 12; 6; 1; 1; 1; 3; 6; 1; 1 [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; [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], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], 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
A03
Brand name suffix
ULTRA ANTITOX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRYONIA ALBA ROOT1 [hp_X]/mL
APIS MELLIFERA2 [hp_X]/mL
ASPARAGUS6 [hp_X]/mL
AVENA SATIVA FLOWERING TOP1 [hp_X]/mL
ALFALFA2 [hp_X]/mL
AMERICAN GINSENG1 [hp_X]/mL
FERROUS IODIDE12 [hp_X]/mL
SODIUM CARBONATE1 [hp_X]/mL
BARIUM IODIDE15 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP15 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP1 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
SCROPHULARIA NODOSA12 [hp_X]/mL
TARAXACUM OFFICINALE6 [hp_X]/mL
CALCIUM HEXAFLUOROSILICATE1 [hp_X]/mL
ARCTOSTAPHYLOS UVA-URSI LEAF1 [hp_X]/mL
MATRICARIA CHAMOMILLA1 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK6 [hp_X]/mL
MILK THISTLE1 [hp_X]/mL
CHELIDONIUM MAJUS1 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 21 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T7J046YI2BInternal UNII lookup
7S82P3R43ZInternal UNII lookup
Z1EJP3037ZInternal UNII lookup
MA9CQJ3F7FInternal UNII lookup
DJO934BRBDInternal UNII lookup
8W75VCV53QInternal UNII lookup
F5452U54PNInternal UNII lookup
45P3261C7TInternal UNII lookup
WKC4T7680AInternal UNII lookup
CLF5YFS11OInternal UNII lookup
Q28R5GF371Internal UNII lookup
C88X29Y479Internal UNII lookup
7H443NUB2TInternal UNII lookup
39981FM375Internal UNII lookup
2NVP93XVQ3Internal UNII lookup
3M5V3D1X36Internal UNII lookup
G0R4UBI2ZZInternal UNII lookup
5405K23S50Internal UNII lookup
1TH8Q20J0UInternal UNII lookup
U946SH95EEInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b945cb81-aee4-38e8-e053-2a95a90aa8dfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0103-1A03ULTRA ANTITOX30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0103A03 ULTRA ANTITOX (ALFALFA, AMERICAN GINSENG, APIS MELLIFICA, ASPARAGUS OFFICINALIS, AVENA SATIVA, BARYTA IODATA, BERBERIS VULGARIS, BRYONIA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, CONIUM MACULATUM, FERRUM IODATUM, LAPIS ALBUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, PASSIFLORA INCARNATA, SCROPHULARIA NODOSA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA URSI) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_b945cb81-aee4-38e8-e053-2a95a90aa8df.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A03 ULTRA ANTITOXALFALFA, AMERICAN GINSENG, APIS MELLIFICA, ASPARAGUS OFFICINALIS, AVENA SATIVA, BARYTA IODATA, BERBERIS VULGARIS, BRYONIA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, CONIUM MACULATUM, FERRUM IODATUM, LAPIS ALBUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, PASSIFLORA INCARNATA, SCROPHULARIA NODOSA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA URSIApex Energetics Inc.b945cb81-aee4-38e8-e053-2a95a90aa8df2024-01-08WarningsExact identifier
ndc (product): 63479-0103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-0103-16347901030130 mL in 1 BOTTLE, GLASS (63479-0103-1) 30 ml1994-12-150000-00-00NoNoCurrent