N03

Product NDC
63479-1403
11-digit product format
634791403
Labeler code
63479
Product ID
63479-1403_0e77340b-340c-fe13-e063-6294a90a0301
Type
HUMAN OTC DRUG
Nonproprietary name
ALLIUM SATIVUM, ARSENICUM ALBUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, BETULA VERRUCOSA, CALCAREA CARBONICA, CARBOLICUM ACIDUM, CHELIDONIUM MAJUS, CHLORINUM, CITRICUM ACIDUM, HISTAMINUM, ICHTHYOLUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM BICARBONICUM, SODIUM HYPOCHLORITE, SOLIDAGO VIRGAUREA, SULPHUR
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1988-08-15
Substance
ANHYDROUS CITRIC ACID; ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BETULA PENDULA LEAF; CHELIDONIUM MAJUS; CHLORINE; GARLIC; HISTAMINE DIHYDROCHLORIDE; ICHTHAMMOL; JUNIPERUS COMMUNIS STEM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENOL; SODIUM BICARBONATE; SODIUM HYPOCHLORITE; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR
Active strength
30; 30; 30; 12; 9; 9; 30; 15; 30; 15; 9; 30; 30; 30; 30; 30; 30; 9; 15 [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
Acidifying Activity [MoA], Alkalinizing Activity [MoA], Allergens [CS], Ammonium Ion Binding Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Nitrogen Binding Agent [EPC], Non-Standardized Food Allergenic Extract [EPC], Plant 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
N03
Brand name suffix
EXCHEM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
JUNIPERUS COMMUNIS STEM9 [hp_X]/mL
SODIUM HYPOCHLORITE30 [hp_X]/mL
ARSENIC TRIOXIDE30 [hp_X]/mL
PHENOL30 [hp_X]/mL
CHELIDONIUM MAJUS9 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE30 [hp_X]/mL
ICHTHAMMOL15 [hp_X]/mL
GARLIC15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE30 [hp_X]/mL
MERCURIUS SOLUBILIS30 [hp_X]/mL
SODIUM BICARBONATE30 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP9 [hp_X]/mL
ANHYDROUS CITRIC ACID30 [hp_X]/mL
BENZOIC ACID30 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK12 [hp_X]/mL
BETULA PENDULA LEAF9 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]/mL
CHLORINE30 [hp_X]/mL
SULFUR15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 19 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HBU87MH6OYInternal UNII lookup
DY38VHM5ODInternal UNII lookup
S7V92P67HOInternal UNII lookup
339NCG44TVInternal UNII lookup
7E889U5RNNInternal UNII lookup
3POA0Q644UInternal UNII lookup
NQ14646378Internal UNII lookup
V1V998DC17Internal UNII lookup
C88X29Y479Internal UNII lookup
324Y4038G2Internal UNII lookup
8MDF5V39QOInternal UNII lookup
5405K23S50Internal UNII lookup
XF417D3PSLInternal UNII lookup
8SKN0B0MIMInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
5HW39H9KDHInternal UNII lookup
2E32821G6IInternal UNII lookup
4R7X1O2820Internal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba73a050-9a5d-1549-e053-2a95a90a62aaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1403-1N03EXCHEM1 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1403N03 EXCHEM (ALLIUM SATIVUM, ARSENICUM ALBUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, BETULA VERRUCOSA, CALCAREA CARBONICA, CARBOLICUM ACIDUM, CHELIDONIUM MAJUS, CHLORINUM, CITRICUM ACIDUM, HISTAMINUM, ICHTHYOLUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM BICARBONICUM, SODIUM HYPOCHLORITE, SOLIDAGO VIRGAUREA, SULPHUR) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_ba73a050-9a5d-1549-e053-2a95a90a62aa.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
N03 EXCHEMALLIUM SATIVUM, ARSENICUM ALBUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, BETULA VERRUCOSA, CALCAREA CARBONICA, CARBOLICUM ACIDUM, CHELIDONIUM MAJUS, CHLORINUM, CITRICUM ACIDUM, HISTAMINUM, ICHTHYOLUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM BICARBONICUM, SODIUM HYPOCHLORITE, SOLIDAGO VIRGAUREA, SULPHURApex Energetics Inc.ba73a050-9a5d-1549-e053-2a95a90a62aa2024-01-08WarningsExact identifier
ndc (product): 63479-1403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-1403-1634791403011 mL in 1 BOTTLE, GLASS (63479-1403-1) 1 ml1997-07-150000-00-00NoNoCurrent