Home NDC 44911-0077-1 Relaxatone
Product NDC 44911-0077
Requested package NDC 44911-0077-1
11-digit product format 449110077
Labeler code 44911
Product ID 44911-0077_6a2c0261-aa0b-4ed0-97fa-350e07842734
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 2013-04-12
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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 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 44911-0077-1 Relaxatone 30 mL in 1 BOTTLE, DROPPER LIQUID 30 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ARABICA COFFEE BEAN ACTIVE INGREDIENT 3SW678MX72 RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 ARSENIC TRIOXIDE ACTIVE INGREDIENT S7V92P67HO RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 DELPHINIUM STAPHISAGRIA SEED ACTIVE INGREDIENT 00543AP1JV RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 LYCOPUS VIRGINICUS ACTIVE INGREDIENT TWH5125Q6F RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 OYSTER SHELL CALCIUM CARBONATE, CRUDE ACTIVE INGREDIENT 2E32821G6I RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 PASSIFLORA INCARNATA FLOWERING TOP ACTIVE INGREDIENT CLF5YFS11O RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 POTASSIUM PHOSPHATE, DIBASIC ACTIVE INGREDIENT CI71S98N1Z RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 SCUTELLARIA LATERIFLORA ACTIVE INGREDIENT 7BP4DH5PDC RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 STRYCHNOS IGNATII SEED ACTIVE INGREDIENT 1NM3M2487K RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 VALERIAN ACTIVE INGREDIENT JWF5YAW3QW RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 ARABICA COFFEE BEAN ACTIVE MOIETY 3SW678MX72 RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 ARSENIC CATION (3+) ACTIVE MOIETY C96613F5AV RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 DELPHINIUM STAPHISAGRIA SEED ACTIVE MOIETY 00543AP1JV RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 LYCOPUS VIRGINICUS ACTIVE MOIETY TWH5125Q6F RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 OYSTER SHELL CALCIUM CARBONATE, CRUDE ACTIVE MOIETY 2E32821G6I RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 PASSIFLORA INCARNATA FLOWERING TOP ACTIVE MOIETY CLF5YFS11O RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 PHOSPHATE ION ACTIVE MOIETY NK08V8K8HR RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 SCUTELLARIA LATERIFLORA ACTIVE MOIETY 7BP4DH5PDC RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 STRYCHNOS IGNATII SEED ACTIVE MOIETY 1NM3M2487K RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 VALERIAN ACTIVE MOIETY JWF5YAW3QW RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0077 RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20241031_2547b712-9190-4b25-ad8c-61f74cd4cb6e.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. 2547b712-9190-4b25-ad8c-61f74cd4cb6e 2024-10-30 Warnings Exact identifier ndc (package): 44911-0077-1 ndc (product): 44911-0077 ndc11 (package): 44911007701
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0077-1 44911007701 30 mL in 1 BOTTLE, DROPPER (44911-0077-1) 30 ml 2013-04-12 0000-00-00 No No Current