FDA.reportPublic FDA data

Relaxatone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:28:34

Label at a glance#

ProductRelaxatone
Active ingredientPASSIFLORA INCARNATA FLOWERING TOP, SCUTELLARIA LATERIFLORA WHOLE, VALERIAN, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, POTASSIUM PHOSPHATE, DIBASIC, LYCOPUS VIRGINICUS WHOLE, DELPHINIUM STAPHISAGRIA SEED
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 14.24% of Arsenicum Album 12X, Calcarea Carbonica 12X, Coffea Cruda 12X, Ignatia Amara 12X, Kali Phosphoricum 12X, Lycopus Virginicus 12X, Staphysagria 12X; 0.10% of Passiflora Incarnata 3X, Scutellaria Lateriflora 3X, Valeriana Officinalis 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve anxiety and stress. 

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use. 

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve anxiety and stress.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

RELAXATONE

1 fl. oz. (30 ml)

RelaxatoneRelaxatone

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX721
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JV1
LYCOPUS VIRGINICUSACTIVE INGREDIENTTWH5125Q6F1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11O1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1Z1
SCUTELLARIA LATERIFLORAACTIVE INGREDIENT7BP4DH5PDC1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487K1
VALERIANACTIVE INGREDIENTJWF5YAW3QW1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX721
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JV1
LYCOPUS VIRGINICUSACTIVE MOIETYTWH5125Q6F1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11O1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR1
SCUTELLARIA LATERIFLORAACTIVE MOIETY7BP4DH5PDC1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487K1
VALERIANACTIVE MOIETYJWF5YAW3QW1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-007744911-0077-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
SCUTELLARIA LATERIFLORA WHOLE7BP4DH5PDCACTIB
VALERIANJWF5YAW3QWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
LYCOPUS VIRGINICUS WHOLETWH5125Q6FACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RelaxatonePASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDAEnergique, Inc.2547b712-9190-4b25-ad8c-61f74cd4cb6e2024-10-30WarningsExact identifier
ndc (package): 44911-0077-1
ndc (product): 44911-0077
ndc11 (package): 44911007701
spl id: 6a2c0261-aa0b-4ed0-97fa-350e07842734
spl set id: 2547b712-9190-4b25-ad8c-61f74cd4cb6e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.