FDA.reportPublic FDA data

Homeopathic Calm Drops

Manufacturer
HISTORICAL REMEDIES LLP.
Effective date
2025-10-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:37:18

Label at a glance#

ProductHomeopathic Calm Drops
Active ingredientARSENIC TRIOXIDE, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, POTASSIUM CARBONATE, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, PHOSPHORIC ACID, PULSATILLA VULGARIS WHOLE, VALERIAN, ACONITUM NAPELLUS WHOLE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED
Label structure6 sections

Dosage and administration

Adults and children over 8: Dissolve one Calm Drops lozenge in mouth. Repeat every half hour as needed.

Label contents#

Full prescribing information#

Indications

INDICATIONS & USAGE SECTION

For temporary relief of occasional anxiety, tension and irritability. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Aconitum nap 6X, Arsenicum alb 30C, Calcarea carb 30X, Chamomilla 12X, Ignatia 30X, Kali carb 30C, Lachesis 12X, Natrum mur 12X, Nux vom 30C, Phosphoricum ac 3X, Pulsatilla 12C, Sepia 30C.

Equal volumes of each ingredient.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 8: Dissolve one Calm Drops lozenge in mouth. Repeat every half hour as needed.

Warnings

WARNINGS SECTION

If symptoms persist more than 7 days or worsen, consult a physician. Keep out of children's reach.In case of overdose, get medical help or contact a poison control center right away. If pregnant or breast-feeding,ask a doctor before use. Do not use if shrink wrap is broken or missing.

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap 6X, Arsenicum alb 30C, Calcarea carb 30X, Chamomilla 12X, lgnatia 30X, Kali carb 30C, Lachesis 12X, Natrum mur 12X, Nux vom 30C, Phosphoricum ac 3X, Pulsatilla 12C, Sepia 30C.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, Organic Vanilla Flavor.

4 calories per lozenge. 1 gram sugar per lozenge. No gluten added.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57556-006-01Homeopathic Calm Drops30 in 1 BOXLOZENGE307

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57556-00657556-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSE MONOHYDRATELX22YL083GIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
ACHLYS TRIPHYLLA WHOLE91THU5EJ2IIACT
ARSENIC TRIOXIDES7V92P67HOACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
VALERIANJWF5YAW3QWACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-10-31full-release2026-06-01 02:28:45

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
Homeopathic Calm DropsARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30CHISTORICAL REMEDIES LLP.69c35bc2-b9a0-4bb4-a56d-0e2d1c3f79582025-10-07WarningsExact identifier
ndc (package): 57556-006-01
ndc (product): 57556-006
ndc11 (package): 57556000601
spl id: 4093d3c7-ecde-a030-e063-6294a90a885f
spl set id: 69c35bc2-b9a0-4bb4-a56d-0e2d1c3f7958

Reported adverse events (FAERS/openFDA)#

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