N01

Product NDC
63479-1401
11-digit product format
634791401
Labeler code
63479
Product ID
63479-1401_0e77063c-fc41-cee6-e063-6394a90a0d54
Type
HUMAN OTC DRUG
Nonproprietary name
ADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUM
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1997-07-15
Substance
ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CHELIDONIUM MAJUS; EPINEPHRINE; GOLD; HYPERICUM PERFORATUM; NICKEL; PASSIFLORA INCARNATA TOP; QUININE ARSENITE; SARSAPARILLA; SILICON DIOXIDE; SILVER NITRATE; SODIUM FLUORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; ZINC VALERATE DIHYDRATE
Active strength
12; 1; 1; 12; 1; 4; 30; 3; 15; 1; 12; 2; 20; 15; 12; 1; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
N01
Brand name suffix
PROTOMER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA12 [hp_X]/mL
AVENA SATIVA FLOWERING TOP1 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK1 [hp_X]/mL
CALCIUM SULFIDE12 [hp_X]/mL
CHELIDONIUM MAJUS1 [hp_X]/mL
EPINEPHRINE4 [hp_C]/mL
GOLD30 [hp_X]/mL
HYPERICUM PERFORATUM3 [hp_X]/mL
NICKEL15 [hp_X]/mL
PASSIFLORA INCARNATA TOP1 [hp_X]/mL
QUININE ARSENITE12 [hp_X]/mL
SARSAPARILLA2 [hp_X]/mL
SILICON DIOXIDE20 [hp_X]/mL
SILVER NITRATE15 [hp_X]/mL
SODIUM FLUORIDE12 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP1 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG12 [hp_X]/mL
ZINC VALERATE DIHYDRATE12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO80TY208ZW, MA9CQJ3F7F, 1TH8Q20J0U, 1MBW07J51Q, 7E889U5RNN, YKH834O4BH, 79Y1949PYO, XK4IUX8MNB, 7OV03QG267, CLF5YFS11O, 42QO5P0NLM, 2H1576D5WG, ETJ7Z6XBU4, 95IT3W8JZE, 8ZYQ1474W7, 5405K23S50, 1NT28V9397, MN0RX54EQA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
22bca8fc-c2b1-897d-b515-117a7522ccaeProduct name320150731
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1401-1N01PROTOMER30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1401N01 PROTOMER (ADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUM) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bfc8e049-2f62-31c4-e053-2a95a90a6e16.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-1401-16347914010130 mL in 1 BOTTLE, GLASS (63479-1401-1) 30 ml1997-07-150000-00-00NoNoCurrent