Home NDC 44911-0500-1 Melatonin Pro
Product NDC 44911-0500
Requested package NDC 44911-0500-1
11-digit product format 449110500
Labeler code 44911
Product ID 44911-0500_bdfbe914-ba46-48a2-885f-a5c8b74c8f7b
Type HUMAN OTC DRUG
Nonproprietary name Calcarea Carbonica, Chamomilla, Cocculus Indicus, Coffea Cruda, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Carbonica, Melatonin, Natrum Muriaticum, Nux Vomica, Pulsatilla (Pratensis)
Dosage form TABLET
Route ORAL
Labeler Energique, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2019-06-07
Substance ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; DIBASIC POTASSIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; MAGNESIUM CARBONATE; MATRICARIA CHAMOMILLA; MELATONIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA PRATENSIS WHOLE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED
Active strength 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes Allergens [CS], Allergens [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], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 44911-0500 44911-0500-1 I Inactivated by FDA excluded / ndc_excluded.zip 8dfbde2a14a4…c9ff85d89658…
Additional Listing Data#
Finished product Yes
Brand name base Melatonin Pro
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/1 MATRICARIA CHAMOMILLA 12 [hp_X]/1 ANAMIRTA COCCULUS SEED 12 [hp_X]/1 ARABICA COFFEE BEAN 12 [hp_X]/1 FERROSOFERRIC PHOSPHATE 12 [hp_X]/1 DIBASIC POTASSIUM PHOSPHATE 12 [hp_X]/1 MAGNESIUM CARBONATE 12 [hp_X]/1 MELATONIN 12 [hp_X]/1 SODIUM CHLORIDE 12 [hp_X]/1 STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/1 PULSATILLA PRATENSIS WHOLE 12 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 11 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44911-0500-1 Melatonin Pro 60 in 1 BOTTLE, PLASTIC TABLET 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0500 MELATONIN PRO (CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)) TABLET [ENERGIQUE, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20230722_1f374642-83f7-4e64-b330-0f6ef21000a9.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 Melatonin Pro CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS) Energique, Inc. 1f374642-83f7-4e64-b330-0f6ef21000a9 2023-07-19 Warnings Exact identifier ndc (package): 44911-0500-1 ndc (product): 44911-0500 ndc11 (package): 44911050001
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0500-1 44911050001 60 TABLET in 1 BOTTLE, PLASTIC (44911-0500-1) 60 tablet 2019-06-07 2024-06-19 No No Current