Home NDC 63479-2304 W04
Product NDC 63479-2304
11-digit product format 634792304
Labeler code 63479
Product ID 63479-2304_0e7729de-1053-e578-e063-6394a90a7de6
Type HUMAN OTC DRUG
Nonproprietary name AMERICAN GINSENG, AVENA SATIVA, CHAMOMILLA, COFFEA TOSTA, ESCHSCHOLTZIA CALIFORNICA, GLYCYRRHIZA GLABRA, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA VULGARIS, VALERIANA OFFICINALIS, ZINCUM VALERIANICUM
Dosage form SOLUTION/ DROPS
Route SUBLINGUAL
Labeler Apex Energetics Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1994-08-15
Substance AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; COFFEA ARABICA SEED, ROASTED; ESCHSCHOLZIA CALIFORNICA; GLYCYRRHIZA GLABRA; HOPS; HYPERICUM PERFORATUM; MATRICARIA CHAMOMILLA; PASSIFLORA INCARNATA TOP; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; VALERIAN; ZINC VALERATE DIHYDRATE
Active strength 1; 1; 12; 1; 1; 1; 3; 3; 1; 10; 9; 12; 1; 12 [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base W04
Brand name suffix NEUROCALM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYPERICUM PERFORATUM 1 [hp_X]/mL POTASSIUM PHOSPHATE, DIBASIC 1 [hp_X]/mL MATRICARIA CHAMOMILLA 12 [hp_X]/mL ESCHSCHOLZIA CALIFORNICA 1 [hp_X]/mL PASSIFLORA INCARNATA TOP 1 [hp_X]/mL VALERIAN 1 [hp_X]/mL HOPS 3 [hp_X]/mL PHOSPHORUS 3 [hp_X]/mL PULSATILLA VULGARIS 1 [hp_X]/mL ZINC VALERATE DIHYDRATE 10 [hp_X]/mL AMERICAN GINSENG 9 [hp_X]/mL AVENA SATIVA FLOWERING TOP 12 [hp_X]/mL COFFEA ARABICA SEED, ROASTED 1 [hp_X]/mL GLYCYRRHIZA GLABRA 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 14 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 63479-2304-1 W04NEUROCALM 60 mL in 1 BOTTLE, GLASS SOLUTION/ DROPS 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63479-2304 W04 NEUROCALM (AMERICAN GINSENG, AVENA SATIVA, CHAMOMILLA, COFFEA TOSTA, ESCHSCHOLTZIA CALIFORNICA, GLYCYRRHIZA GLABRA, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA VULGARIS, VALERIANA OFFICINALIS, ZINCUM VALERIANICUM) SOLUTION/ DROPS [APEX ENERGETICS INC.] 2 Current NDC, Legacy NDC, 1 package rows 20240110_bf50b27a-e6d0-5393-e053-2995a90a1dff.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 W04 NEUROCALM AMERICAN GINSENG, AVENA SATIVA, CHAMOMILLA, COFFEA TOSTA, ESCHSCHOLTZIA CALIFORNICA, GLYCYRRHIZA GLABRA, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA VULGARIS, VALERIANA OFFICINALIS, ZINCUM VALERIANICUM Apex Energetics Inc. bf50b27a-e6d0-5393-e053-2995a90a1dff 2024-01-08 Warnings Exact identifier ndc (product): 63479-2304
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63479-2304-1 63479230401 60 mL in 1 BOTTLE, GLASS (63479-2304-1) 60 ml 1994-08-15 0000-00-00 No No Current