Home NDC 63479-1401-1 N01
Product NDC 63479-1401
Requested package NDC 63479-1401-1
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 EPINEPHRINE; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; ARNICA MONTANA; SARSAPARILLA; GOLD; CHELIDONIUM MAJUS; NICKEL; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; SOLIDAGO VIRGAUREA FLOWERING TOP; ZINC VALERATE DIHYDRATE; CALCIUM SULFIDE; SODIUM FLUORIDE; QUININE ARSENITE; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA TOP
Active strength 4; 15; 1; 1; 12; 2; 30; 1; 15; 20; 12; 1; 12; 12; 12; 12; 3; 1 [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; [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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base N01
Brand name suffix PROTOMER
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPINEPHRINE 4 [hp_C]/mL SILVER NITRATE 15 [hp_X]/mL AVENA SATIVA FLOWERING TOP 1 [hp_X]/mL BERBERIS VULGARIS ROOT BARK 1 [hp_X]/mL ARNICA MONTANA 12 [hp_X]/mL SARSAPARILLA 2 [hp_X]/mL GOLD 30 [hp_X]/mL CHELIDONIUM MAJUS 1 [hp_X]/mL NICKEL 15 [hp_X]/mL SILICON DIOXIDE 20 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG 12 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP 1 [hp_X]/mL ZINC VALERATE DIHYDRATE 12 [hp_X]/mL CALCIUM SULFIDE 12 [hp_X]/mL SODIUM FLUORIDE 12 [hp_X]/mL QUININE ARSENITE 12 [hp_X]/mL HYPERICUM PERFORATUM 3 [hp_X]/mL PASSIFLORA INCARNATA TOP 1 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 18 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63479-1401-1 N01PROTOMER 30 mL in 1 BOTTLE, GLASS SOLUTION/ DROPS 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63479-1401 N01 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.] 2 Current NDC, Legacy NDC, 1 package rows 20240110_bfc8e049-2f62-31c4-e053-2a95a90a6e16.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join N01 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 Apex Energetics Inc. bfc8e049-2f62-31c4-e053-2a95a90a6e16 2024-01-08 Warnings Exact identifier ndc (package): 63479-1401-1 ndc (product): 63479-1401 ndc11 (package): 63479140101
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63479-1401-1 63479140101 30 mL in 1 BOTTLE, GLASS (63479-1401-1) 30 ml 1997-07-15 0000-00-00 No No Current