FDA.reportPublic FDA data

Relaxatone

Product NDC
44911-0077
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

Additional Listing Data#

Finished product
Yes
Brand name base
Relaxatone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARABICA COFFEE BEAN12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED12 [hp_X]/mL
LYCOPUS VIRGINICUS WHOLE12 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]/mL
POTASSIUM PHOSPHATE, DIBASIC12 [hp_X]/mL
SCUTELLARIA LATERIFLORA WHOLE3 [hp_X]/mL
STRYCHNOS IGNATII SEED12 [hp_X]/mL
VALERIAN3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3SW678MX72, S7V92P67HO, 00543AP1JV, TWH5125Q6F, 2E32821G6I, CLF5YFS11O, CI71S98N1Z, 7BP4DH5PDC, 1NM3M2487K, JWF5YAW3QW

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0077-12024-10-30C16284748780-1ba0f9c33-25c3-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0077-12023-01-30C16284748780-1ba0f9c33-25c3-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0077-12021-03-12C16284748780-1ba0f9c33-25c3-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0077-12021-01-29C16284748780-1ba0f9c33-25c3-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0077-1Relaxatone30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX72RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HORELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JVRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
LYCOPUS VIRGINICUSACTIVE INGREDIENTTWH5125Q6FRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6IRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11ORELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1ZRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
SCUTELLARIA LATERIFLORAACTIVE INGREDIENT7BP4DH5PDCRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487KRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
VALERIANACTIVE INGREDIENTJWF5YAW3QWRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX72RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AVRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JVRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
LYCOPUS VIRGINICUSACTIVE MOIETYTWH5125Q6FRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6IRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11ORELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
SCUTELLARIA LATERIFLORAACTIVE MOIETY7BP4DH5PDCRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487KRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
VALERIANACTIVE MOIETYJWF5YAW3QWRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MRELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RRELAXATONE (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
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0077RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.]4Current NDC, Legacy NDC, 1 package rows20241031_2547b712-9190-4b25-ad8c-61f74cd4cb6e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0077-14491100770130 mL in 1 BOTTLE, DROPPER (44911-0077-1) 30 ml2013-04-120000-00-00NoNoCurrent