Home NDC 44911-0640 Relaxatone
Product NDC 44911-0640
11-digit product format 449110640
Labeler code 44911
Product ID 44911-0640_ffdad01b-2ad0-45af-a545-76d40fd266f9
Type HUMAN OTC DRUG
Nonproprietary name Passiflora Incarnata, Scutellaria Lateriflora, Valeriana Officinalis, Arsenicum Album, Calcarea Carbonica, Coffea Cruda
Dosage form LIQUID
Route ORAL
Labeler Energique, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2021-06-22
Substance ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; DELPHINIUM STAPHISAGRIA SEED; LYCOPUS VIRGINICUS WHOLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SCUTELLARIA LATERIFLORA WHOLE; STRYCHNOS IGNATII SEED; VALERIAN
Active strength 12; 12; 12; 12; 12; 3; 12; 3; 12; 3 [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], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 44911-0640-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 44911-0640-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 44911-0640-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 44911-0640-1 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Relaxatone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PASSIFLORA INCARNATA FLOWERING TOP 12 [hp_X]/mL SCUTELLARIA LATERIFLORA WHOLE 12 [hp_X]/mL VALERIAN 12 [hp_X]/mL ARSENIC TRIOXIDE 12 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL ARABICA COFFEE BEAN 3 [hp_X]/mL STRYCHNOS IGNATII SEED 12 [hp_X]/mL POTASSIUM PHOSPHATE, DIBASIC 3 [hp_X]/mL LYCOPUS VIRGINICUS WHOLE 12 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED 3 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 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 44911-0640-1 Relaxatone 60 mL in 1 BOTTLE, DROPPER LIQUID 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0640 RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240713_98fd169f-84b7-415e-a7e8-bbb7d7f81ac4.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 Relaxatone PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA Energique, Inc. 98fd169f-84b7-415e-a7e8-bbb7d7f81ac4 2024-07-12 Warnings Exact identifier ndc (product): 44911-0640
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0640-1 44911064001 60 mL in 1 BOTTLE, DROPPER (44911-0640-1) 60 ml 2021-06-22 0000-00-00 No No Current